Publications by authors named "Shabina Ariff"

45 Publications

Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection: The INTERCOVID Multinational Cohort Study.

JAMA Pediatr 2021 Apr 22. Epub 2021 Apr 22.

College of Medicine, University of Ibadan, Ibadan, Nigeria.

Importance: Detailed information about the association of COVID-19 with outcomes in pregnant individuals compared with not-infected pregnant individuals is much needed.

Objective: To evaluate the risks associated with COVID-19 in pregnancy on maternal and neonatal outcomes compared with not-infected, concomitant pregnant individuals.

Design, Setting, And Participants: In this cohort study that took place from March to October 2020, involving 43 institutions in 18 countries, 2 unmatched, consecutive, not-infected women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge.

Exposures: COVID-19 in pregnancy determined by laboratory confirmation of COVID-19 and/or radiological pulmonary findings or 2 or more predefined COVID-19 symptoms.

Main Outcomes And Measures: The primary outcome measures were indices of (maternal and severe neonatal/perinatal) morbidity and mortality; the individual components of these indices were secondary outcomes. Models for these outcomes were adjusted for country, month entering study, maternal age, and history of morbidity.

Results: A total of 706 pregnant women with COVID-19 diagnosis and 1424 pregnant women without COVID-19 diagnosis were enrolled, all with broadly similar demographic characteristics (mean [SD] age, 30.2 [6.1] years). Overweight early in pregnancy occurred in 323 women (48.6%) with COVID-19 diagnosis and 554 women (40.2%) without. Women with COVID-19 diagnosis were at higher risk for preeclampsia/eclampsia (relative risk [RR], 1.76; 95% CI, 1.27-2.43), severe infections (RR, 3.38; 95% CI, 1.63-7.01), intensive care unit admission (RR, 5.04; 95% CI, 3.13-8.10), maternal mortality (RR, 22.3; 95% CI, 2.88-172), preterm birth (RR, 1.59; 95% CI, 1.30-1.94), medically indicated preterm birth (RR, 1.97; 95% CI, 1.56-2.51), severe neonatal morbidity index (RR, 2.66; 95% CI, 1.69-4.18), and severe perinatal morbidity and mortality index (RR, 2.14; 95% CI, 1.66-2.75). Fever and shortness of breath for any duration was associated with increased risk of severe maternal complications (RR, 2.56; 95% CI, 1.92-3.40) and neonatal complications (RR, 4.97; 95% CI, 2.11-11.69). Asymptomatic women with COVID-19 diagnosis remained at higher risk only for maternal morbidity (RR, 1.24; 95% CI, 1.00-1.54) and preeclampsia (RR, 1.63; 95% CI, 1.01-2.63). Among women who tested positive (98.1% by real-time polymerase chain reaction), 54 (13%) of their neonates tested positive. Cesarean delivery (RR, 2.15; 95% CI, 1.18-3.91) but not breastfeeding (RR, 1.10; 95% CI, 0.66-1.85) was associated with increased risk for neonatal test positivity.

Conclusions And Relevance: In this multinational cohort study, COVID-19 in pregnancy was associated with consistent and substantial increases in severe maternal morbidity and mortality and neonatal complications when pregnant women with and without COVID-19 diagnosis were compared. The findings should alert pregnant individuals and clinicians to implement strictly all the recommended COVID-19 preventive measures.
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http://dx.doi.org/10.1001/jamapediatrics.2021.1050DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8063132PMC
April 2021

Effectiveness of management of severe acute malnutrition (SAM) through community health workers as compared to a traditional facility-based model: a cluster randomized controlled trial.

Eur J Nutr 2021 Apr 20. Epub 2021 Apr 20.

Department of Pediatric and Child Health, Associate Director Center of Excellence in Women and Child Health, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.

Purpose: We compared the impact of management of severe acute malnutrition (SAM) by lady health workers (LHWs) at a community level with the standard CMAM program provided at the health facility.

Methods: A two-arm cluster randomised controlled trial was conducted in a rural district in sindh Pakistan. The primary outcome was recovery from SAM and secondary outcomes were relapse, defaulter and mortality rate.

Results: A total of 829 children were recruited in the trial (430 in intervention and 399 in control groups). No significant difference was noted in recovery rate between the intervention and control groups (79.2% vs 85.6%, p = 0.276). Similarly, no significant differences were noted in relapse (p = 0.757), weight gain (p = 0.609), deaths (p = 0.775) and defaulter rate (p = 0.324) across the groups. Compliance of RUTF was significantly higher in the control group (93%) than in the intervention group (87%), p < 0.000.

Conclusion: Our results showed no impact of SAM treatment on performance indicators of CMAM (recovery, relapse, death and default) between the standard CMAM programme performed at the health facility by the government and NGO staff and the programme performed at health house level by the LHWs in Pakistan. We recommend further robust trials in other settings to confirm our results.
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http://dx.doi.org/10.1007/s00394-021-02550-yDOI Listing
April 2021

Bovine Lactoferrin to Prevent Neonatal Infections in Low-Birth-Weight Newborns in Pakistan: Protocol for a Three-Arm Double-Blind Randomized Controlled Trial.

JMIR Res Protoc 2021 Mar 11;10(3):e23994. Epub 2021 Mar 11.

School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

Background: Sepsis is a common and severe complication in premature neonates, particularly those born with low birth weights (<2500 g). Neonatal sepsis is steadily emerging as a leading cause of neonatal mortality in Pakistan. Lactoferrin is a natural product with broad-spectrum antimicrobial properties and glycoprotein that is actively involved in innate immune host responses. Clinical trials have revealed its protective effect on sepsis, but lactoferrin dosage, duration, and role in the prevention of sepsis are still uncertain.

Objective: We aimed to establish the efficacy of bovine lactoferrin in the prevention of late-onset sepsis and to determine the optimal dose and method of administering bovine lactoferrin that may contribute to improvement in overall survival of low birth weight infants.

Methods: We will implement the study in 2 phases at the Aga Khan University Hospital. The first phase, which we have completed, was formative research. This phase mainly focused on a qualitative exploration of perceptions about feeding and caring practices of low birth weight newborns and a trial of improved practices for the preparation and administration of bovine lactoferrin to newborns. The second phase is a 3-arm double-blind randomized controlled trial. In this phase, we randomly allocated 2 different daily oral prophylactic doses of bovine lactoferrin (150 mg or 300 mg) and placebo to 300 low-birth weight neonates starting within the first 72 hours of birth and continuing for the first 28 days of life.

Results: The study protocol was approved by the Ethics Review Committee of Aga Khan University on August 16, 2017. Data collection began in April 2018 and was completed in September 2020. Data analyses are yet to be completed. We expect the results to be published in peer-reviewed journals by autumn of 2021.

Conclusions: This intervention, if effective, has the potential to be translated into a safe, affordable, and widely utilized treatment to prevent sepsis and, subsequently, may improve the survival outcomes of low birth weight neonates in Pakistan and other low- and middle-income countries.

Trial Registration: ClinicalTrials.gov NCT03431558; https://clinicaltrials.gov/ct2/show/NCT03431558.

International Registered Report Identifier (irrid): PRR1-10.2196/23994.
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http://dx.doi.org/10.2196/23994DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7995063PMC
March 2021

Determinants of infant and young complementary feeding practices among children 6-23 months of age in urban Pakistan: a multicenter longitudinal study.

BMC Nutr 2020 Dec 16;6(1):75. Epub 2020 Dec 16.

Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Background: Suboptimal feeding practices have a negative impact on children's health and growth in the first 2 years of life and increase their risk of undernutrition, morbidity, and mortality. The aim of the study was to assess the factors that influence infant and young child feeding practices among urban mothers in a hospital setting at Karachi, Pakistan.

Methods: A longitudinal multi-center cohort study was conducted in four countries, MULTICENTER BODY COMPOSITION REFERENCE STUDY (MBCRS) to produce normal body composition reference data in healthy infants from 3 months to 24 months of age. Repeated anthropometric (weight, length and head circumference) and body composition measurements using "deuterium dilution method" along with 24-h dietary recall questionnaires were performed on 250 healthy term infants at 3, 6, 9, 12, 18, and 24 months of age. The 24-h dietary recall data from this study was used to assess the breastfeeding and complementary feeding practices in children aged 6-24 months.

Results: A total of 250 healthy infants were enrolled in the study. A majority of newborns (75.4%) were exclusively breastfed till 3 months of age; however, by 6 months of age, only 30.2% of infants were exclusively breastfed. Only 44.1% of children aged 6-24 months achieved minimum dietary diversity (MDD), 84.7% achieved minimum meal frequency (MMF), and 44.1% achieved a minimum acceptable diet (MAD). 71.4% achieved MDD and MAD and 100% achieved MMF at 24 months. The bivariate analysis found that breastfed children (OR 3.93, 95% CI 2.72-5.68), with employed mothers (OR 1.55, 95% CI 1.06-2.27) who had graduated from secondary school (OR 1.45, 95% CI 1.08-1.94) were more likely to meet minimum dietary diversity. The multivariable analysis showed that only the child's age was significantly associated with MDD (p value< 0.0001), with the likelihood of meeting MDD increasing as the children aged; 9 months (OR 18.96, 95% CI 6.63-54.19), 12 months (OR 40.25, 95% CI 14.14-114.58), 18 months (OR 90.02, 95% CI 30.84-262.77) and 24 months (OR 82.14, 95% CI 27.23-247.83).

Conclusion: Our study revealed that Infant and young child feeding practices are significantly associated with maternal education, employment, and the child's age. Therefore, it is essential that investments be made towards protective breastfeeding and complementary feeding policies and legislations, emphasis on female education and ensuring the availability of affordable nutritious and diverse foods.
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http://dx.doi.org/10.1186/s40795-020-00401-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7739450PMC
December 2020

Simulator-based ultrasound training for identification of endotracheal tube placement in a neonatal intensive care unit using point of care ultrasound.

BMC Med Educ 2020 Nov 7;20(1):409. Epub 2020 Nov 7.

Pediatric Emergency Medicine, McMaster Children's Hospital, Hamilton, Canada.

Background: Simulators are an extensively utilized teaching tool in clinical settings. Simulation enables learners to practice and improve their skills in a safe and controlled environment before using these skills on patients. We evaluated the effect of a training session utilizing a novel intubation ultrasound simulator on the accuracy of provider detection of tracheal versus esophageal neonatal endotracheal tube (ETT) placement using point-of-care ultrasound (POCUS). We also investigated whether the time to POCUS image interpretation decreased with repeated simulator attempts.

Methods: Sixty neonatal health care providers participated in a three-hour simulator-based training session in the neonatal intensive care unit (NICU) of Aga Khan University Hospital (AKUH), Karachi, Pakistan. Participants included neonatologists, neonatal fellows, pediatric residents and senior nursing staff. The training utilized a novel low-cost simulator made with gelatin, water and psyllium fiber. Training consisted of a didactic session, practice with the simulator, and practice with intubated NICU patients. At the end of training, participants underwent an objective structured assessment of technical skills (OSATS) and ten rounds of simulator-based testing of their ability to use POCUS to differentiate between simulated tracheal and esophageal intubations.

Results: The majority of the participants in the training had an average of 7.0 years (SD 4.9) of clinical experience. After controlling for gender, profession, years of practice and POCUS knowledge, linear mixed model and mixed effects logistic regression demonstrated marginal improvement in POCUS interpretation over repeated simulator testing. The mean time-to-interpretation decreased from 24.7 (SD 20.3) seconds for test 1 to 10.1 (SD 4.5) seconds for Test 10, p < 0.001. There was an average reduction of 1.3 s (β = - 1.3; 95% CI: - 1.66 to - 1.0) in time-to-interpretation with repeated simulator testing after adjusting for the covariates listed above.

Conclusion: We found a three-hour simulator-based training session had a significant impact on technical skills and performance of neonatal health care providers in identification of ETT position using POCUS. Further research is needed to examine whether these skills are transferable to intubated newborns in various health settings.

Trial Registration: ClinicalTrials.gov Identifier: NCT03533218 . Registered May 2018.
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http://dx.doi.org/10.1186/s12909-020-02338-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7648944PMC
November 2020

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

N Engl J Med 2020 12 23;383(26):2514-2525. Epub 2020 Oct 23.

The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).

Background: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.

Methods: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.

Results: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.

Conclusions: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).
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http://dx.doi.org/10.1056/NEJMoa2022398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660991PMC
December 2020

Evaluating implementation of "management of Possible Serious Bacterial Infection (PSBI) when referral is not feasible" in primary health care facilities in Sindh province, Pakistan.

PLoS One 2020 14;15(10):e0240688. Epub 2020 Oct 14.

Center of Excellance in Women & Child Health, Aga Khan University, Karachi, Pakistan.

Background: The World Health Organization (WHO) launched a guideline in 2015 for managing Possible Serious Bacterial Infection (PSBI) when referral is not feasible in young infants aged 0-59 days. This guideline was implemented across 303 Basic Health Unit (BHU) Plus primary health care (PHC) facilities in peri-urban and rural settings of Sindh, Pakistan. We evaluated the implementation of PSBI guideline, and the quality of care provided to sick young infants at these facilities.

Methods: Thirty (10%) out of 303 BHU Plus facilities were randomly selected for evaluation. A survey team visited each facility for one day, assessed the health system support, observed the management of sick young infants by health care providers (HCP), validated their management, interviewed HCPs and caretakers of sick infants. HCPs who were unable to see a young infant on the day of survey were evaluated using pre-prepared case scenarios.

Results: Thirty (100%) BHU Plus facilities had oral amoxicillin, injectable gentamicin, thermometers, baby weighing scales and respiratory timers available; 29 (97%) had disposable syringes and needles; 28 (93%) had integrated management of childhood illness (IMCI)/PSBI chart booklets and job aids and 18 (60%) had a functional ambulance. Each facility had at least one HCP trained in PSBI, and 21 (70%) facilities had been visited by a supervisor in the preceding six months. Of 42 HCPs, 19 (45.3%) were trained within the preceding 12 months. During the survey, 26 sick young infants were identified in 18 facilities. HCPs asked about history of breastfeeding in 23 (89%) infants, history of vomiting in 17 (65%), and history of convulsions in 14 (54%); weighed 25 (97%) infants; measured respiratory rate in all (100%) and temperature in 24 (92%); assessed 20 (77%) for movement and 14 (54%) for chest indrawing. HCPs identified two infants with fast breathing pneumonia and managed them correctly per IMCI/PSBI protocol. HCPs identified six (23%) infants with clinical severe infection (CSI), two of them were referred to a higher-level facility, only one accepted the referral advice. Only one CSI patient was managed correctly per IMCI/PSBI protocol at the outpatient level. HCPs described the PSBI danger signs to eight (31%) caretakers. Caretakers of five infants with CSI and two with pneumonia were not counselled for PSBI danger signs. Five of the six CSI cases categorized by HCPs were validated as CSI on re-examination, whereas one had pneumonia. Similarly, one of the two pneumonia patients categorized by HCPs had CSI and one identified as local bacterial infection was classified as CSI upon re-examination.

Conclusion: Health system support was adequate but clinical management and counselling by HCPs was sub-optimal particularly with CSI cases who are at higher risk of adverse outcomes. Scaling up PSBI management is potentially feasible in PHC facilities in Pakistan, provided that HCPs are trained well and mentored, receive refresher training to appropriately manage sick young infants, and have adequate supplies and counselling skills.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240688PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556471PMC
December 2020

Effect of an integrated neonatal care kit on cause-specific neonatal mortality in rural Pakistan.

Glob Health Action 2020 12;13(1):1802952

Centre for Global Child Health, The Hospital for Sick Children , Toronto, Canada.

Background: In 2018, Pakistan had the world's highest neonatal mortality rate. Within Pakistan, most neonatal deaths occur in rural areas where access to health facilities is limited, and robust vital registration systems are lacking. To improve newborn survival, there is a need to better understand the causes of neonatal death in high burden settings and engage caregivers in the promotion of newborn health.

Objective: To describe the causes of neonatal death in a rural area in Pakistan and to estimate the effect of an integrated neonatal care kit (iNCK) on cause-specific neonatal mortality.

Methods: We analyzed data from a community-based, cluster-randomized controlled trial of 5286 neonates in Rahim Yar Khan (RYK), Punjab, Pakistan between April 2014 and August 2015. In intervention clusters, Lady Health Workers (LHW) delivered the iNCK and education on its use to pregnant women while control clusters received the local standard of care. The iNCK included interventions to prevent and identify signs of infection, identify low birthweight (LBW), and identify and manage hypothermia. Verbal autopsies were attempted for all deaths. The primary outcome was cause-specific neonatal mortality.

Results: Verbal autopsies were conducted for 84 (57%) of the 147 reported neonatal deaths. The leading causes of death were infection (44%), intrapartum-related complications (26%) and prematurity/LBW (20%). There were no significant differences in neonatal mortality due to prematurity/LBW (RR 0.43; 95% CI 0.15-1.24), infection (RR 1.10; 95% CI 0.58-2.10) or intrapartum-related complications (RR 1.04; 95% CI 0.0.45-2.41) among neonates who died in the intervention arm compared to those who died in the control arm.

Conclusion: The major causes of neonatal deaths in RYK, Pakistan mirror the global landscape of neonatal deaths. The iNCK did not significantly reduce any cause-specific neonatal mortality.
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http://dx.doi.org/10.1080/16549716.2020.1802952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7480452PMC
December 2020

Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial.

JMIR Res Protoc 2020 Aug 24;9(8):e19001. Epub 2020 Aug 24.

Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Background: In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country-43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households.

Objective: The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months.

Methods: A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package.

Results: The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020.

Conclusions: The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months.

Trial Registration: ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218.

International Registered Report Identifier (irrid): DERR1-10.2196/19001.
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http://dx.doi.org/10.2196/19001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7477667PMC
August 2020

Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial.

PLoS One 2020 13;15(8):e0237210. Epub 2020 Aug 13.

Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Background: Chronic childhood malnutrition, or stunting, remains a persistent barrier to achieve optimal cognitive development, child growth and ability to reach full potential. Almost half of children under-five years of age are stunted in the province of Sindh, Pakistan.

Objective: The primary objective of this study was to test the hypothesis that the provision of lipid-based nutrient supplement-medium-quantity (LNS-MQ) known as Wawamum will result in a 10% reduction in risk of being stunted at the age of 24 months in the intervention group compared with the control group.

Design: A cluster randomized controlled trial was conducted in Thatta and Sujawal districts of Sindh province, Pakistan. A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study. The unit of randomization was union council and considered as a cluster. A total of 12 clusters, 6 in each study group were randomly assigned to intervention and control group. All children received standard government health services, while children in the intervention group also received 50 grams/day of Wawamum.

Results: Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88-0.94, p<0.001) and wasting (RR = 0.78, 95% CI; 0.67-0.92, p = 0.004) as compared to children who received the standard government health services. There was no evidence of a reduction in the risk of underweight (RR = 0.94, 95% CI; 0.85-1.04, p = 0.235) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94-0.99, p = 0.042). The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008). The mean compliance of Wawamum was 60% among children.

Conclusions: The study confirmed that the provision of Wawamum to children 6-23 months of age is effective in reducing the risk of stunting, wasting and anaemia. This approach should be scaled up among the most food insecure areas/households with a high prevalence of stunting to achieve positive outcomes for nutrition and health. This study was registered at clinicaltrials.gov as NCT02422953. Clinical Trial Registration Number: NCT02422953.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237210PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425934PMC
October 2020

Characteristics Of Preterm With Sight Threatening Retinopathy Of Prematurity.

J Ayub Med Coll Abbottabad 2020 Apr- Jun;32(2):174-178

Department of Pediatrics and Child Health.

Background: Retinopathy of prematurity (ROP) is a preventable and treatable vasoproliferative disorder of the retina which develops mostly in preterm babies. It is a leading cause of childhood blindness and more common in under developed countries. Prevalence of the severe ROP is 7.7% in Pakistan. We reviewed the characteristics of preterm babies with severe ROP to evaluate the predictors of sight threatening ROP.

Methods: Our study was conducted at the NICU of Aga Khan University Hospital which is a tertiary care private sector hospital in Karachi. Ninety-seven cases of severe ROP were found out of which 83 cases were enrolled. Data on determinants for ROP were collected including gestational age, birth weight, weight gain at two and four weeks, h/o blood transfusion, supplementary oxygen, presence of PDA and its treatment. Data analysis was done by using SPSS version 20.0.

Results: Frequency of severe ROP in our cohort was 5.95%. Mean gestational age for severe ROP was 28.27±1.79 and mean birth weight was 1069.16±271.71 grams. The overall mean weight gain per week in these babies was 94.62±75.64 grams. Supplementary oxygen was provided in almost 100% (82/83 cases) of cases. Surfactant was given to 56.6 % babies. PDA was found in 23 cases out of which 19 were treated by medical therapy whereas surgical treatment was done in 4 cases.

Conclusions: Severe Retinopathy of prematurity was directly correlated with low birth weight, and gestational age. An average, weight gain in four weeks was lower in ROP babies (94.62±75.64 grams) than the recommended weight gain (WHO recommended 140-210 gm per week). This could be associated with the development and severity of ROP requiring treatment. Therefore, a prospective case control study is required to further identify risk factors associated with the above cohort. Screening and follow up of all such babies according to the international criteria is the need of the day.
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November 2020

Effectiveness of wheat soya blend supplementation during pregnancy and lactation on pregnancy outcomes and nutritional status of their infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan: a cluster randomized-controlled trial.

Eur J Nutr 2021 Mar 24;60(2):781-789. Epub 2020 May 24.

Institute for Global Health and Development, A, Aga Khan University, Karachi, Pakistan.

Purpose: We aimed to assess the effectiveness of wheat soya blend plus (WSBP) provided during pregnancy and lactation on weight gain during pregnancy, reduction of low birthweight (LBW), and improvement in nutritional status in infants at 6 months of age in Thatta and Sujawal districts of Sindh, Pakistan.

Methods: A cluster randomized-controlled trial was conducted in Thatta and Sujawal districts in Pakistan from August 2014 to December 2016. A total of 2030 pregnant women were enrolled in the study. These women and their infants were followed during pregnancy and first 6 months of life. Pregnant women received a monthly ration of 5 kg (i.e., 165 g/day) of WSB + during pregnancy and the first 6 months of their lactation period.

Results: There was no difference in weight gain during pregnancy between the intervention and control groups (n = 496, 326.7 g/week 95% CI 315.2-338.1 vs. (n = 507, 306.9 g/week, 95% CI 279.9-333.9 P = 0.192), after adjustment with different factors. The reduction in the prevalence of LBW was not different between intervention and control groups (n = 325, 34.0%, 95% CI 31.7-36.4, vs. (n = 127, 34.3%, 95% CI 27.2-41.5, P = 0.932). Significant reductions in risk of stunting (n = 1319 RR 0.85, 95% CI 0.73-0.99, P = 0.041), wasting (n = 1330 RR 0.77, 95% CI 0.65-0.91, P = 0.003), and underweight (n = 1295 RR 0.77, 95% CI 0.69-0.87, P < 0.001) were observed in infants at 6 months of age in the intervention as compared to the control group. However, no difference was noted on reduction in the risk of stunting among infants at 6 months of age in the intervention and control group (n = 1318 RR 0.91, 95% CI 0.78-1.07, P = 0.253) after adjustment. A significant reduction in anemia was noted (n = 1328 RR 0.94, 95% CI 0.91-0.98, P = 0.002) in infants at 6 months of age in the intervention as compared to the control group in adjusted analysis.

Conclusions: Provision of WSB + during pregnancy and the first 6 months of lactation is effective in reducing the risk of under nutrition and anemia in infants at 6 months of age. This study can potentially guide the government and donor agencies in investing in nutritional programmes, especially for pregnant and lactating women living in vulnerable settings.
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http://dx.doi.org/10.1007/s00394-020-02276-3DOI Listing
March 2021

CLABSI reduction using evidence based interventions and nurse empowerment: a quality improvement initiative from a tertiary care NICU in Pakistan.

Arch Dis Child 2021 Apr 6;106(4):394-400. Epub 2020 Apr 6.

Department of Pediatrics & Child Health, The Aga Khan University, Karachi, Sindh, Pakistan.

Objective: Central line associated bloodstream infection (CLABSI) is an important cause of morbidity and mortality in the neonatal intensive care unit (NICU). We designed a CLABSI Prevention Package (CPP) to decrease NICU CLABSI rates, using evidence-proven interventions.

Design: This was a quality improvement (QI) project. Data collection was divided into three phases (pre-implementation, implementation and post implementation). SQUIRE2.0 guidelines were used to design, implement and report this QI initiative.

Setting: A tertiary care level 3 NICU at the Aga Khan University Hospital (AKUH), Karachi, Pakistan.

Patients: All patients admitted to the AKUH NICU from 1 January 2016 to 31 March 2018 who had a central line in place during their NICU admission.

Interventions: CPP used evidence-based interventions focusing on hand hygiene, aseptic central line insertion techniques and central line care, prevention of fungal infections and nurse empowerment.

Main Outcome Measures: CLABSI rates pre and post intervention were recorded. Secondary outcomes were risk factors for CLABSI, device (central line) utilisation ratio, CLABSI related mortality and micro-organism profile.

Results: CLABSI rates decreased from 17.1/1000 device days to 5.0/1000 device days (relative risk (RR)=0.36, CI=0.17-0.74). Device (central line) utilisation ratio declined from 0.30 to 0.25. Out of 613 patients enrolled in our study, 139 (22.7%) died. Mortality was higher in CLABSI group (n=20, 44%) as compared with non CLABSI group (n=119, 21.1%) (p<0.001). Gestational age of <27 weeks was an independent risk factor for CLABSI (RR=4.45, CI=1.10-18.25, p=0.03). A total of 158 pathogens were isolated among which 68 were associated with CLABSI. Gram-negative bacteria 31 (47.7%) were the most common cause of CLABSI. Ninety-seven (61%) micro-organisms were multi-drug resistant.

Conclusions: CPP was effective in decreasing NICU CLABSI rates and can be used as a model to decrease NICU CLABSI rates in low or middle-income countries.
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http://dx.doi.org/10.1136/archdischild-2019-318779DOI Listing
April 2021

Frequency of Early Morbidities in Low Birth Weight Neonates at The Aga Khan University Hospital, Karachi.

Cureus 2019 Nov 3;11(11):e6061. Epub 2019 Nov 3.

Pediatrics and Child Health, Aga Khan University Hospital, Karachi, PAK.

Background Globally, approximately 14.6% children are born with low birth weight (LBW) annually. In Pakistan, this figure however reaches approximately 16%. Low birth weight infants are vulnerable to develop early morbidities like hypothermia, hypoglycemia, respiratory distress syndrome and hypocalcemia. There is a scarcity of statistics which creates a gap in development of strategies for improving quality of care in developing countries. The aim of our study was to determine the frequency of early morbidities such as respiratory distress syndrome (RDS), hypoglycemia, hypothermia and hypocalcemia in low birth weight neonates. Methodology A prospective descriptive study was conducted via non-probability sampling technique from 1 April 2016 to 30 September 2016 at The Aga Khan University Hospital, Karachi. All low birth weight infants, i.e., those with birth weight < 2500 grams were included in this study and observed for early morbidities, including hypothermia, hypoglycemia, hypocalcemia and respiratory distress syndrome. Descriptive analysis was done using SPSS version 22 (IBM Corp., Armonk, NY), mean and standard deviation were determined for quantitative variables, whereas frequency and percentages were calculated for qualitative variables. Results A total of 2082 neonates were born during the study period, of which 271 (13%) were born with low birth weight. One hundred and eighty-five (68.1%) of these LBW neonates were preterm babies while 86 (31.9%) were born at term. Among LBW neonates 137 (51.0%) were males and 134 (49.0%) females. In the study population, hypoglycemia was seen in 17.3%, hypocalcemia in 13.6%, respiratory distress syndrome in 11%, and hypothermia in 2.5%. Conclusion Our study highlighted major early morbidities of LBW neonates, and their association with birth weight, gestational age and gender. Significant association of birth weight was found with hypothermia and hypocalcemia, whereas hypocalcemia and RDS were significantly associated with gestational age. However, none of the early morbidities had significant association with gender. Keeping in perspective the early morbidities in this population we propose that priority be given to providing adequate attention to low birth weight neonates.
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http://dx.doi.org/10.7759/cureus.6061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6890161PMC
November 2019

Frequency and Early Complications of Late Preterm Infants: A Descriptive Analysis from Two Secondary-care Hospitals of Karachi.

Cureus 2019 Sep 28;11(9):e5789. Epub 2019 Sep 28.

Pediatrics and Child Health, Aga Khan University Hospital, Karachi, PAK.

Introduction Globally, prematurity accounts for 12.7% of all live births while late preterm accounts for around three-fourth (73%) of these premature births. In Pakistan, the prevalence of prematurity is approximately 18.89%. Late preterm infants often have weight and size similar to some term infants, but they are still metabolically and physiologically immature. Hence, these infants, as compared to term infants, are at a higher risk of developing medical complications, which results in higher morbidity and mortality during the birth hospitalization. We aim to determine the frequency of early complications in late preterm infants during their stay at Aga Khan Secondary-care Hospitals, Karachi. Methods A prospective descriptive study was conducted via the nonprobability sampling technique from March 22, 2016, to March 22, 2017, at secondary-care hospitals of The Aga Khan University Hospital; The Aga Khan Hospital for Women, Karimabad, and The Aga Khan Hospital for Women and Children, Garden. All late-preterm infants, i.e. those born between the 34 through 36 weeks gestation were included in this study and observed for 72 hours after birth for early complications, including hypothermia, sepsis, hypoglycemia, respiratory distress, and hyperbilirubinemia. Descriptive analysis was done using SPSS Version 19.0 (IBM Corp., Armonk, NY, US) and frequency and percentages were calculated. Results Throughout the period of study, a total of 1696 infants were born in secondary-care hospitals, of which 86.67% (n=1470) were term and 13.3% (n=226) were preterm. Late preterm infants constituted 95.5% (n=217) of preterm births and 12.7% of all newborns delivered at study sites. Among them, respiratory distress was diagnosed in 23.5%, hyperbilirubinemia in 17.5%, hypoglycemia in 13.8%, sepsis in 9.2%, and hypothermia in 6%. Conclusion Late preterm neonates form the major subgroup of preterm infants delivered at secondary-care hospitals. They have a significant risk of morbidity and birth hospitalizations. We propose that late preterm infants, regardless of their physical dimensions, be given medical attention similar to all preterms.
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http://dx.doi.org/10.7759/cureus.5789DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6827863PMC
September 2019

A novel training simulator for portable ultrasound identification of incorrect newborn endotracheal tube placement - observational diagnostic accuracy study protocol.

BMC Pediatr 2019 11 13;19(1):434. Epub 2019 Nov 13.

Department of Paediatrics & Child Health, Aga Khan University, Stadium Road, Karachi, 74800, Pakistan.

Background: Endotracheal tube (ETT) placement is a critical procedure for newborns that are unable to breathe. Inadvertent esophageal intubation can lead to oxygen deprivation and consequent permanent neurological impairment. Current standard-of-care methods to confirm ETT placement in neonates (auscultation, colorimetric capnography, and chest x-ray) are time consuming or unreliable, especially in the stressful resuscitation environment. Point-of-care ultrasound (POCUS) of the neck has recently emerged as a powerful tool for detecting esophageal ETTs. It is accurate and fast, and is also easy to learn and perform, especially on children.

Methods: This will be an observational diagnostic accuracy study consisting of two phases and conducted at the Aga Khan University Hospital in Karachi, Pakistan. In phase 1, neonatal health care providers that currently perform standard-of-care methods for ETT localization, regardless of experience in portable ultrasound, will undergo a two-hour training session. During this session, providers will learn to detect tracheal vs. esophageal ETTs using POCUS. The session will consist of a didactic component, hands-on training with a novel intubation ultrasound simulator, and practice with stable, ventilated newborns. At the end of the session, the providers will undergo an objective structured assessment of technical skills, as well as an evaluation of their ability to differentiate between tracheal and esophageal endotracheal tubes. In phase 2, newborns requiring intubation will be assessed for ETT location via POCUS, at the same time as standard-of-care methods. The initial 2 months of phase 2 will include a quality assurance component to ensure the POCUS accuracy of trained providers. The primary outcome of the study is to determine the accuracy of neck POCUS for ETT location when performed by neonatal providers with focused POCUS training, and the secondary outcome is to determine whether neck POCUS is faster than standard-of-care methods.

Discussion: This study represents the first large investigation of the benefits of POCUS for ETT confirmation in the sickest newborns undergoing intubations for respiratory support.

Trial Registration: ClinicalTrials.gov Identifier: NCT03533218. Registered May 2018.
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http://dx.doi.org/10.1186/s12887-019-1717-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852924PMC
November 2019

Quality improvement initiative using transcutaneous bilirubin nomogram to decrease serum bilirubin sampling in low-risk babies.

BMJ Paediatr Open 2019 24;3(1):e000403. Epub 2019 Apr 24.

Department of Paediatrics and Child Health, The Aga Khan University, Karachi, Pakistan.

Background: Screening for neonatal hyperbilirubinaemia in the postnatal ward has traditionally been performed using serum bilirubin sampling, but this has significant drawbacks such as risk of infection and slower reporting time.

Objective: We aimed to assess the impact of introducing transcutaneous bilirubin (TcBR) testing using TcBR nomogram on the number of serum bilirubin samples sent.

Methods: A before-and-after study was performed following the introduction of a protocol integrating the use of the Dragger JM-105 transcutaneous bilirubinometer in the postnatal ward. Only babies born at ≥37 weeks of gestation, weighing ≥2500 g who presented with jaundice after the first 24 hours and within the first 7 days of life were included in the study. The number of total serum bilirubin samples (TSBRs) sent were compared for the 6-month periods before and after (a total of 12 months) implementation of the new protocol.

Results: In the pre-implementation phase, a total of 882 (49%) out of 1815 babies had at least one serum bilirubin sample taken as opposed to a total of 236 (17%) out of 1394 babies in the post-implementation phase. The odds of performing TSBRs at least one time among babies in post-implementation phase were 79% lower than in pre-implementation phase (OR 0.21, 95% CI 0.18 to 0.25). We also estimated a significant cost saving of approximately US$1800 over a period of 6 months.

Conclusion: TcBR testing used in conjunction with our proposed nomogram significantly reduces the need for serum bilirubin sampling.
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http://dx.doi.org/10.1136/bmjpo-2018-000403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6542442PMC
April 2019

Effect of an integrated neonatal care kit on neonatal health outcomes: a cluster randomised controlled trial in rural Pakistan.

BMJ Glob Health 2019 16;4(3):e001393. Epub 2019 May 16.

Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada.

Introduction: In 2016, 2.6 million children died during their first month of life. We assessed the effectiveness of an integrated neonatal care kit (iNCK) on neonatal survival and other health outcomes in rural Pakistan.

Methods: We conducted a community-based, cluster randomised, pragmatic, open-label, controlled intervention trial in Rahim Yar Khan, Punjab, Pakistan. Clusters, 150 villages and their lady health workers (LHWs), were randomly assigned to deliver the iNCK (intervention) or standard of care (control). In intervention clusters, LHWs delivered the iNCK and education on its use to pregnant women. The iNCK contained a clean birth kit, chlorhexidine, sunflower oil, a continuous temperature monitor (ThermoSpot), a heat reflective blanket and reusable heat pack. LHWs were also given a hand-held scale. The iNCK was implemented primarily by caregivers. The primary outcome was all-cause neonatal mortality. Outcomes are reported at the individual level, adjusted for cluster allocation. Enrolment took place between April 2014 and July 2015 and participant follow-up concluded in August 2015.

Results: 5451 pregnant women (2663 and 2788 in intervention and control arms, respectively) and their 5286 liveborn newborns (2585 and 2701 in intervention and control arms, respectively) were enrolled. 147 newborn deaths were reported, 65 in the intervention arm (25.4 per 1000 live births) compared with 82 in the control arm (30.6 per 1000 live births). Neonatal mortality was not significantly different between treatment groups (risk ratio 0.83, 95% CI 0.58 - 1.18; p = 0.30).

Conclusion: Providing co-packaged interventions directly to women did not significantly reduce neonatal mortality. Further research is needed to improve compliance with intended iNCK use.
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http://dx.doi.org/10.1136/bmjgh-2019-001393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6528753PMC
May 2019

An Asian multicenter retrospective study on persistent pulmonary hypertension of the newborn: incidence, etiology, diagnosis, treatment and outcome.

J Matern Fetal Neonatal Med 2020 Jun 4;33(12):2032-2037. Epub 2018 Dec 4.

Department of Neonatal and Developmental Medicine, Singapore General Hospital, Singapore.

To explore the incidence, etiologies, diagnostic methods, treatment options and outcomes in neonates with persistent pulmonary hypertension of the newborn (PPHN) and to identify mortality risk factors in a study from six Asian countries. A retrospective chart review of patients with documented PPHN from seven centers in six Asian countries (Japan, Kuwait, India, Pakistan, Singapore, and Thailand) between 1 January, 2014 and 31 December, 2016, was performed. A total of 369 PPHN infants were identified. The incidence of PPHN ranged from 1.2 to 4.6 per 1000 live births. The all-cause mortality rate was 20.6% (76 of 369). Meconium aspiration syndrome was the primary cause of PPHN (24.1%). In most cases (84.8%) echocardiography was used to establish the diagnosis of PPHN. Sildenafil was the most commonly used pulmonary vasodilator (51.2%). Multivariate multiple regression analysis indicated gestational age <34 weeks (adjusted odds ratio (OR) = 3.27; 95% CI 1.56-6.74), congenital diaphragmatic hernia (CDH)/lung hypoplasia (LH) (adjusted OR = 6.13 (95% CI 2.28-16.42)), treatment with high frequency oscillation ventilation (HFOV) with or without inhaled nitric oxide (iNO) (adjusted OR = 3.11 (95% CI 1.52-6.34)), and inotropic agents (adjusted OR = 9.43 (95% CI 2.71-32.83)) were independently associated with increased risk of death. The incidence of PPHN in the current study was higher than in western settings. Birth weight, gestational age, CDH/LH, HFOV/iNO, and inotropic agents were significant mortality risk factors.
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http://dx.doi.org/10.1080/14767058.2018.1536740DOI Listing
June 2020

Causes and incidence of community-acquired serious infections among young children in south Asia (ANISA): an observational cohort study.

Lancet 2018 07 6;392(10142):145-159. Epub 2018 Jul 6.

Department of Microbiology, Child Health Research Foundation, Dhaka Shishu Hospital, Sher-E-Bangla Nagar, Dhaka, Bangladesh.

Background: More than 500 000 neonatal deaths per year result from possible serious bacterial infections (pSBIs), but the causes are largely unknown. We investigated the incidence of community-acquired infections caused by specific organisms among neonates in south Asia.

Methods: From 2011 to 2014, we identified babies through population-based pregnancy surveillance at five sites in Bangladesh, India, and Pakistan. Babies were visited at home by community health workers up to ten times from age 0 to 59 days. Illness meeting the WHO definition of pSBI and randomly selected healthy babies were referred to study physicians. The primary objective was to estimate proportions of specific infectious causes by blood culture and Custom TaqMan Array Cards molecular assay (Thermo Fisher, Bartlesville, OK, USA) of blood and respiratory samples.

Findings: 6022 pSBI episodes were identified among 63 114 babies (95·4 per 1000 livebirths). Causes were attributed in 28% of episodes (16% bacterial and 12% viral). Mean incidence of bacterial infections was 13·2 (95% credible interval [CrI] 11·2-15·6) per 1000 livebirths and of viral infections was 10·1 (9·4-11·6) per 1000 livebirths. The leading pathogen was respiratory syncytial virus (5·4, 95% CrI 4·8-6·3 episodes per 1000 livebirths), followed by Ureaplasma spp (2·4, 1·6-3·2 episodes per 1000 livebirths). Among babies who died, causes were attributed to 46% of pSBI episodes, among which 92% were bacterial. 85 (83%) of 102 blood culture isolates were susceptible to penicillin, ampicillin, gentamicin, or a combination of these drugs.

Interpretation: Non-attribution of a cause in a high proportion of patients suggests that a substantial proportion of pSBI episodes might not have been due to infection. The predominance of bacterial causes among babies who died, however, indicates that appropriate prevention measures and management could substantially affect neonatal mortality. Susceptibility of bacterial isolates to first-line antibiotics emphasises the need for prudent and limited use of newer-generation antibiotics. Furthermore, the predominance of atypical bacteria we found and high incidence of respiratory syncytial virus indicated that changes in management strategies for treatment and prevention are needed. Given the burden of disease, prevention of respiratory syncytial virus would have a notable effect on the overall health system and achievement of Sustainable Development Goal.

Funding: Bill & Melinda Gates Foundation.
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http://dx.doi.org/10.1016/S0140-6736(18)31127-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6053599PMC
July 2018

Effectiveness of transcutaneous bilirubin measurement in managing neonatal jaundice in postnatal ward of a tertiary care hospital in Pakistan.

BMJ Paediatr Open 2017 31;1(1):e000065. Epub 2017 Aug 31.

Department of Pediatrics, The Aga Khan University Hospital, Karachi, Sindh, Pakistan.

Introduction: Neonatal jaundice is a common cause of concern in immediate newborn period for parents as well as for the caregivers. Babies with visible jaundice are identified by the healthcare provider, and blood samples are sent for confirmation. Clinical expertise varies from person to person and may lead to sending excessive blood sampling. Obtaining blood bilirubin samples is a painful procedure; it predisposes the baby to infections and requires skilled health personnel. Moreover, laboratory tests are costly and time consuming, leading to unnecessary delays in commencing phototherapy and discharge from hospital. Transcutaneous bilirubinometer has been in use for a long time as screening tool in postnatal wards. With passage of time, its accuracy and validity have improved tremendously.

Methodology: We aim to implement a quality improvement initiative to reduce the number of blood bilirubin samples using transcutaneous bilirubin (TcBR) nomogram in full-term, low-risk babies who are born at our hospital and are admitted in postnatal ward after birth. Using preanalysis and postanalysis study design, this study will be performed in two phases of 6 months each. Data regarding total number of admissions in postnatal wards, demographics, serum bilirubin(TSBR) samplings and need for phototherapy will be recorded in both phases. TcBR will be done and recorded in postimplementation phase.

Analysis And Results: Comparisons between the two groups will be made. Primary outcome will be reduction in blood bilirubin samples for TSBR after the implementation of TcBr protocol. The proportion of infants having TSBR performed in both periods will be compared. Crude sampling cost of TSBR will be obtained from laboratory, and cost comparison between two phases will be done to look for difference.
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http://dx.doi.org/10.1136/bmjpo-2017-000065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5862169PMC
August 2017

A protocol for quality improvement programme to reduce central line-associated bloodstream infections in NICU of low and middle income country.

BMJ Paediatr Open 2017 1;1(1):e000008. Epub 2017 Nov 1.

Department of Pediatrics, The Aga Khan University Hospital, Karachi, Pakistan.

Introduction: Central line-associated bloodstream infections (CLABSI) are the most important cause of morbidity and mortality in critically ill patients. Evidence-based interventions when used in form of a bundle have proven to decrease CLABSI. Our unit has a high CLABSI rate (9/1000 central line days). Therefore, we intend to introduce evidence-based CLABSI prevention package in our practice to improve CLABSI rates in our NICU within limited resources.

Methods And Analysis: The study will be conducted using preanalysis and postanalysis design from January 2016 to December 2017. It is going to be conducted in three phases with phase I being the preimplimentation phase where retrospective data will be collected. Phase II, implementation phase, where the CLABSI prevention package will be introduced and phase III will be follow-up to see the impact. Primary outcome will be reduction in CLABSI rates.

Analysis Plan And Reporting: For all three phases, descriptive analysis will be performed. Nominal data will be presented as mean±SD, whereas categorical data will be presented as frequencies and percentages. To compare the effect of intervention we will use independent sample t-test for continuous outcomes, whereas Χ test will be used for categorical outcomes. Relative risk ratios, 95% CI, and p values will be determined. Incidence density will be calculated and Poisson regression will be used to determine factors associated with incidence of CLABSI. Microbiological profiles and antimicrobial resistance pattern will be reported as pan sensitive, multidrug-resistant organism and carbapenem-resistant organism. SQUIRE V.2.0 guidelines will be used for manuscript writing and reporting.
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http://dx.doi.org/10.1136/bmjpo-2017-000008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842986PMC
November 2017

Assessment of knowledge, attitudes and practices towards newborn screening for congenital hypothyroidism before and after a health education intervention in pregnant women in a hospital setting in Pakistan.

Int Health 2018 Mar;10(2):100-107

Aga Khan University, Karachi, Pakistan.

Background: Most congenital hypothyroidism (CH) is not avertable; however, the adverse effects of CH are preventable with early detection and treatment. It is a common congenital endocrine disorder that affects 1 in 2000-4000 newborns globally. The true incidence in Pakistan is unknown. Data from hospital studies quote an incidence of 1 in 1600-2000. The aim of this study was to uncover existing knowledge of CH and screening for the condition and to assess the impact of health education on mothers' knowledge and attitudes towards having their newborns screened.

Methods: The study was conducted from January 2012 to August 2013 at a local hospital in Karachi, Pakistan. This was a prospective, interventional cohort study implemented through a pre- and post-cross-sectional knowledge, attitudes and practices (KAP) survey. Interviews were conducted using structured questionnaires on CH.

Results: At baseline (pre-intervention survey), 400 participants consented and 355 (88.9%) completed the study. There was a significant increase in awareness among participating women following the intervention (20% to approximately 98%). Similarly, 78.9% agreed to opt for a screening test for their newborns following delivery as compared with 57.7% in the pre-intervention KAP survey (relative risk 1.38, p-value <0.0001).

Conclusion: Unfortunately, the majority of mothers were unaware of CH and its implications, leading to less screening and fewer diagnoses. This study underlines the importance of education in screening programmes to create awareness and maximize uptake.
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http://dx.doi.org/10.1093/inthealth/ihx069DOI Listing
March 2018

Exchangeable Zinc Pool Size at Birth in Pakistani Small for Gestational Age and Appropriate for Gestational Age Infants Do Not Differ But Are Lower Than in US Infants.

J Pediatr Gastroenterol Nutr 2018 03;66(3):496-500

Aga Khan University, Karachi, Pakistan.

Objectives: Small for gestational age (SGA) infants are more susceptible to infectious morbidity and growth faltering compared to their appropriate for gestational age (AGA) counterparts. Zinc supplementation of SGA infants may be beneficial but the underlying susceptibility to zinc deficiency of SGA infants has not been examined.

Methods: In a community-based, observational, longitudinal study in a peri-urban settlement of Karachi, Pakistan, we compared the size of the exchangeable zinc pools (EZPs) in term SGA and AGA infants at birth and at 6 months of age, hypothesizing that the EZP would be lower in the SGA group. To measure EZP size, a zinc stable isotope was intravenously administered within 48 hours of birth (n = 17 and 22) at 6 months (n = 11 and 14) in SGA and AGA infants, respectively. Isotopic enrichment in urine was used to determine EZP.

Results: No significant difference was detected in the mean (±standard deviation) EZP between SGA and AGA infants at birth, with values of 9.8 ± 3.5 and 10.1 ± 4.1 mg/kg, respectively (P = 0.86), or at 6 months. Longitudinal EZP measurements demonstrated a significant decline in EZP relative to body weight in both groups at 6 months (P < 0.001). Mean EZP (adjusted for body weight) size at birth for the combined Pakistani groups was significantly lower than AGA infants at birth in the United States (P = 0.017).

Conclusions: These results did not support a difference in zinc endowment between SGA and AGA Pakistani infants. They, however, do suggest lower in utero zinc transfer to the fetus in a setting where poor maternal nutritional status may confer a high susceptibility to postnatal zinc deficiency.
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http://dx.doi.org/10.1097/MPG.0000000000001778DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6343844PMC
March 2018

Factors associated with low birthweight in term pregnancies: a matched case-control study from rural Pakistan.

East Mediterr Health J 2018 Jan;23(11):754-763

Department of Obstetrics, Gynecology and Neonatology, Central Clinical School, University of Sydney, Sydney, NSW, Australia.

Low birthweight (LBW) remains a significant public health problem in Pakistan and further understanding of factors associated with LBW is required. We conducted a hospital-based matched case control study to identify risk factors associated with LBW in a rural district of Pakistan. We found that illiteracy (AOR: 2.68; 95% CI: 1.59 - 4.38), nulliparity (AOR: 1.82; 95% CI: 1.26-2.44), having a previous miscarriage/abortion (AOR: 1.22; 95% CI: 1.06-2.35), having < 2 antenatal care (ANC) visits during last pregnancy (AOR: 2.43; 95% CI: 1.34-2.88), seeking ANC in third trimester (AOR: 3.62; 95% CI : 2.14-5.03), non-use of iron folic acid during last pregnancy (AOR: 2.72; 95% CI: 1.75-3.17), having hypertension during last pregnancy (AOR: 1.42; 95% CI: 1.13-2.20), being anemic (AOR: 2.67; 95% CI: 1.65-5.24) and having postpartum weight of <45 kg (AOR: 3.30; 95% CI : 1.97-4.52) were significantly associated with an increased odds of having a LBW baby. Our study identifies modifiable risk factors requiring immediate commitment from the health authorities.
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http://dx.doi.org/10.26719/2017.23.11.754DOI Listing
January 2018

Prevalence and possible factors associated with anaemia, and vitamin B and folate deficiencies in women of reproductive age in Pakistan: analysis of national-level secondary survey data.

BMJ Open 2017 12 22;7(12):e018007. Epub 2017 Dec 22.

Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Objective: To determine the prevalence and possible factors associated with anaemia, and vitamin B and folate deficiencies in women of reproductive age (WRA) in Pakistan.

Methods: A secondary analysis was conducted on data collected through the large-scale National Nutrition Survey in Pakistan in 2011. Anaemia was defined as haemoglobin levels <12 g/dL, vitamin B deficiency as serum vitamin B levels of <203 pg/mL (150 pmol/L) and folate deficiency as serum folate levels <4 ng/mL (10 nmol/L).

Results: A total of 11 751 blood samples were collected and analysed. The prevalence of anaemia, vitamin B deficiency and folate deficiency was 50.4%, 52.4% and 50.8%, respectively. After adjustment, the following factors were positively associated with anaemia: living in Sindh province (RR 1.07; 95% CI 1.04 to 1.09) P<0.00, food insecure with moderate hunger (RR 1.03; 95% CI 1.00 to 1.06) P=0.02, four or more pregnancies (RR 1.03; 95% CI 1.01 to 1.05) P<0.00, being underweight (RR 1.03; 95% CI 1.00 to 1.05) P=0.02, being overweight or obese (RR 0.95; 95% CI 0.93 to 0.97) P<0.00 and weekly intake of leafy green vegetables (RR 0.98; 95% CI 0.95 to 1.00) P=0.04. For vitamin B deficiency, a positive association was observed with rural population (RR 0.81; 95% CI 0.66 to 1.00) P=0.04, living in Khyber Pakhtunkhwa province (RR 1.25; 95% CI 1.11 to 1.43) P<0.00 and living in Azad Jammu and Kashmir (RR 1.50; 95% CI 1.08 to 2.08) P=0.01. Folate deficiency was negatively associated with daily and weekly intake of eggs (RR 0.89; 95% CI 0.81 to 0.98) P=0.02 and (RR 0.88; 95% CI 0.78 to 0.99) P=0.03.

Conclusions: In Pakistan, anaemia, and vitamin B and folate deficiencies are a severe public health concern among WRA. Our findings suggest that further research is needed on culturally appropriate short-term and long-term interventions within communities and health facilities to decrease anaemia, and vitamin B and folate deficiencies among Pakistani women.
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http://dx.doi.org/10.1136/bmjopen-2017-018007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5770950PMC
December 2017

Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials.

BMJ Glob Health 2017 30;2(3):e000398. Epub 2017 Aug 30.

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

The scientific basis for antenatal corticosteroids (ACS) for women at risk of preterm birth has rapidly changed in recent years. Two landmark trials-the Antenatal Corticosteroid Trial and the Antenatal Late Preterm Steroids Trial-have challenged the long-held assumptions on the comparative health benefits and harms regarding the use of ACS for preterm birth across all levels of care and contexts, including resource-limited settings. Researchers, clinicians, programme managers, policymakers and donors working in low-income and middle-income countries now face challenging questions of whether, where and how ACS can be used to optimise outcomes for both women and preterm newborns. In this article, we briefly present an appraisal of the current evidence around ACS, how these findings informed WHO's current recommendations on ACS use, and the knowledge gaps that have emerged in the light of new trial evidence. Critical considerations in the generalisability of the available evidence demonstrate that a true state of clinical equipoise exists for this treatment option in low-resource settings. An expert group convened by WHO concluded that there is a clear need for more efficacy trials of ACS in these settings to inform clinical practice.
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http://dx.doi.org/10.1136/bmjgh-2017-000398DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5656119PMC
August 2017

Delayed versus Immediate Cord Clamping in Preterm Infants.

N Engl J Med 2017 12 29;377(25):2445-2455. Epub 2017 Oct 29.

From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (W.T.-M., A. Kirby, K.R., L.A., R.B., S.F., V.G., A. Ghadge, W.H., A. Keech, L. Sebastian, J.S.), University of Sydney (J.M., N.E., M.F., D.I., M.J., M.K., H. Popat, H.L., D.O.), Royal North Shore Hospital (Y.C.), and University of New South Wales (K.L.), Sydney, Australian National University, Canberra (M.A.-L., G.R.), University of Queensland, Brisbane (P.C., H.L., M. Pritchard), James Cook University, Cairns (G.K.), University of Western Australia, Perth (A. Gill, J.N., K.S.), Flinders University, Adelaide (S.M.), Monash University (A.S., E.W.) and University of Melbourne (S.W.), Melbourne, Mercy Hospital for Women, Heidelberg (A.W.), and University of Newcastle, Newcastle (K.W., P.F.), and University of Wollongong, Wollongong (I.W.) - all in Australia; Baylor College of Medicine, Houston (K.A., M.B., M. Pammi); Aga Khan University Hospital, Karachi, Pakistan (S.A., L. Sheikh); Hôpital Antoine-Beclere, Clamart, France (D.L.); University of Nottingham, Nottingham, United Kingdom (L.D.); Dalhousie University, Halifax, NS, Canada (W.E.-N.); University of Auckland, Auckland (K.G.), and University of Otago, Dunedin (P.W., J.G., H. Patel) - both in New Zealand; University College London, London (N.M.), and Royal Jubilee Maternity Hospital, Belfast (D.S.) - both in the United Kingdom; and University of Vermont, Burlington (R.S., L.Y.).

Background: The preferred timing of umbilical-cord clamping in preterm infants is unclear.

Methods: We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (≤10 seconds after delivery) or delayed clamping (≥60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births.

Results: Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P=0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P=0.03 in unadjusted analyses; P=0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities.

Conclusions: Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping. (Funded by the Australian National Health and Medical Research Council [NHMRC] and the NHMRC Clinical Trials Centre; APTS Australian and New Zealand Clinical Trials Registry number, ACTRN12610000633088 .).
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http://dx.doi.org/10.1056/NEJMoa1711281DOI Listing
December 2017

Determinants of infant and young child feeding practices by mothers in two rural districts of Sindh, Pakistan: a cross-sectional survey.

Int Breastfeed J 2017 16;12:40. Epub 2017 Sep 16.

Department of Paediatrics and Child Health, The Aga Khan University, Karachi, Pakistan.

Background: Infant and young child feeding (IYCF) practices during the first two years of life are important for the growth and development of a child. The aim of this study was to assess IYCF practices and its associated factors in two rural districts of Pakistan.

Methods: A cross-sectional study was conducted in two rural districts of Sindh province, Pakistan as part of a stunting prevention project between May and August 2014. A standard questionnaire on IYCF practices recommended by World Health Organization was used to collect information from 2013 mothers who had a child aged between 0 and 23 months.

Results: Only 49% of mothers initiated breastfeeding within one hour of birth. Thirty-seven percent of mothers exclusively breastfed their infants for six months. Seventy-percent mothers introduced complementary feeding at 6-8 months of age. Eighty-two percent of mothers continued breastfeeding for at least one year and 75% for at least two years of age. IYCF practices were not significantly different for boys and girls in the study area. Being an employed mother (AOR 2.14; 95% CI 1.02, 4.51) was positively associated with the early initiation of breastfeeding. Children who were born at a health facility (AOR 0.65; 95% CI 0.50, 0.84) and were aged six to eleven months (AOR 0.70; 95% CI 0.54, 0.90) were less likely to be have an early initiation of breastfeeding. Mothers aged 25 to 29 years (AOR 1.83; 95% CI 1.05, 3.18), being literate (AOR 1.79; 95% CI 1.15, 2.78), and higher income (AOR 10.6; 95% CI 4.40, 25.30) were more likely to have an improved dietary diversity. Being an employed mother (AOR 2.18; 95% CI 1.77, 4.03) and higher income were more likely to have minimum acceptable diet (AOR 9.7; 95% CI 4.33, 21.71).

Conclusion: IYCF practices were below the acceptable level and associated with maternal age, maternal illiteracy, unemployment, and poor household wealth status. Emphasis should be given to improve maternal literacy and reduction in poverty to improve IYCF practices.
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http://dx.doi.org/10.1186/s13006-017-0131-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603092PMC
September 2017

Effect of provision of home-based curative health services by public sector health-care providers on neonatal survival: a community-based cluster-randomised trial in rural Pakistan.

Lancet Glob Health 2017 08;5(8):e796-e806

Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan; Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, Canada. Electronic address:

Background: Although the effectiveness of community mobilisation and promotive care delivered by community health workers in reducing perinatal and neonatal mortality is well established, evidence in support of home-based neonatal resuscitation and infection management is mixed. We assessed the effectiveness of adding training in neonatal bag and mask resuscitation and oral antibiotic therapy for suspected neonatal infections to a basic preventive and promotive interventions package delivered by public sector community-based lady health workers (LHWs) in rural Pakistan.

Methods: We did a cluster-randomised controlled trial in two subdistricts of Naushahro Feroze in rural Sindh, Pakistan, between April 15, 2009, and Dec 10, 2012. LHWs, trained in basic newborn resuscitation and in recognition and treatment (with oral amoxicillin) of suspected neonatal respiratory infections, were linked with traditional birth attendants and encouraged to attend home births. Control clusters received routine care through the existing national programme. The primary outcome was all-cause neonatal mortality. Independent data collection teams recorded data for all pregnancies and their outcomes, morbidity, mortality, and household practices related to maternal and newborn care.

Findings: Of the 27 randomised clusters with functional LHW programmes, 13 were allocated to the intervention group (n=242 749) and 14 to the control group (n=256 985). In the intervention group, LHWs did 80% of the planned community mobilisation sessions, but were able to attend only 1184 (14%) of 8425 deliveries and 4318 (25%) of 17 288 neonatal visits within 72 h of birth (p<0·0001 for both variables compared with the control group). The neonatal mortality rate was 42 deaths per 1000 livebirths in intervention clusters compared with 55 per 1000 in the control group (risk ratio 0·80, 95% CI 0·68-0·93; p=0·005).

Interpretation: The reduction in neonatal mortality in intervention clusters occurred against a background of improvements in domiciliary practices for maternal and newborn care. However, the poor reach of LHWs in accessing newborn infants at birth and in the early postnatal period underscores the limitations of tasking community health workers in public sector programmes working in similar circumstances with such complex interventions. Such community-based interventions in health systems should be accompanied by concerted efforts to improve quality of care in facilities and referral systems.

Funding: Saving Newborn Lives, Save the Children USA.
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http://dx.doi.org/10.1016/S2214-109X(17)30248-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5762815PMC
August 2017