Publications by authors named "Sajid B Soofi"

27 Publications

  • Page 1 of 1

Characterizing Micronutrient Status and Risk Factors among Late Adolescent and Young Women in Rural Pakistan: A Cross-Sectional Assessment of the MaPPS Trial.

Nutrients 2021 Apr 9;13(4). Epub 2021 Apr 9.

Department of Nutritional Sciences, University of Toronto, Toronto, ON M5S 1A8, Canada.

Nutritional deficiencies are a leading underlying risk factor contributing to the global burden of disease. In Pakistan, late adolescence is considered a nutritionally vulnerable period, as micronutrient requirements are increased to support maturation, and dietary staples are nutrient poor. However, there has been limited evaluation of micronutrient status beyond anemia and its determinants. Using cross-sectional data from late adolescent and young women (15-23 years) at enrolment in the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, we aimed to describe the prevalence of key micronutrient deficiencies of public health concern, and generate hierarchical models to examine associations with proxies for social determinants of health (SDoH). The prevalence of micronutrient deficiencies was high: 53.6% (95% confidence interval (CI): 53.0-54.3%) had anemia; 38.0% (95% CI: 36.4-39.6%) iron deficiency anemia; 31.8% (95% CI: 30.2-33.3%) vitamin A deficiency; and 81.1% (95% CI: 79.8-82.4%) vitamin D deficiency. At least one deficiency was experienced by 91.0% (95% CI: 90.1-92.0%). Few SDoH were maintained in the final hierarchical models, although those maintained were often related to socioeconomic status (e.g., education, occupation). To improve the micronutrient status of late adolescent and young women in Pakistan, a direct micronutrient intervention is warranted, and should be paired with broader poverty alleviation methods.
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http://dx.doi.org/10.3390/nu13041237DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8069550PMC
April 2021

The relationship between pubertal timing and under-nutrition in rural Pakistan.

J Adolesc 2021 Apr 19;88:58-66. Epub 2021 Feb 19.

Centre for Global Child Health, Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 11th Floor, Suite 11.9805, Toronto, ON, M5G 0A4, Canada; Department of Nutritional Sciences, University of Toronto, 1 King's Circle College, Toronto, Ontario, M5S 1A8, Canada; Centre of Excellence in Women and Child Health, Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan; Dalla Lana School of Public Health University of Toronto, 155 College Street, 6th Floor, Toronto, ON, M5T 3M7, Canada. Electronic address:

Introduction: Sexual development in females and males are routinely measured according to the Tanner Stages. Sparse data exist on the timing of pubertal milestones in Pakistan. To fill this gap, the age of attainment of pubertal milestones and their relationship with nutritional status was explored among children and adolescents living in the rural district of Matiari, Pakistan.

Methods: Anthropometry, nutrition biomarkers and Tanner Stage were assessed among girls aged 9.0-14.9 years (n = 723) and boys aged 10.0-15.9 years (n = 662) who were free from known disease in the rural District of Matiari, Pakistan. Median age was calculated for all Tanner Stages and menarche. Multivariable linear regressions were undertaken to determine covariates associated with the timing (age) of pubertal milestones.

Results: Among participants living in this rural community, the median age of puberty onset for girls was 11.9 years (95%CI:10.9; 12.5) and boys was 12.3 years (95%CI:11.5; 12.9). Age at first menarche was 12.9 years (95%CI:12.1; 13.3). Undernutrition was widespread among adolescents in this community. Thirty-seven percent of females and 27.0% of males were stunted while 20.5% of females and 31.3% of males were thin. Only 8% (n = 58) of females and 12% (n = 78) of males were free from any nutrient deficiency with most adolescents having two or three nutrient deficiencies.

Conclusions: Undernutrition (stunting or thinness) was associated with relatively older ages for early puberty stages but not puberty completion. This may decrease the duration of the pubertal growth spurt and curtail potential catch-up growth that may occur during puberty. Efforts to decrease nutrient deficiencies, stunting and thinness beyond childhood should be made in rural Pakistan.
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http://dx.doi.org/10.1016/j.adolescence.2021.02.002DOI Listing
April 2021

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

Food supplements to reduce stunting in Pakistan: a process evaluation of community dynamics shaping uptake.

BMC Public Health 2020 Jul 2;20(1):1046. Epub 2020 Jul 2.

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

Background: There is an increasing interest in use of food supplements to prevent childhood stunting, however the evidence on the process indicators is scarce. We in this study explore the barriers to the effective implementation of food supplementation programs and the possible mitigation strategies which can guide the design of future programs.

Methods: We undertook a process evaluation of a stunting prevention food supplementation pilot program in rural Pakistan that distributed Wheat Soy Blend (WSB) to pregnant & lactating women, and Lipid-based Nutrient Supplement (LNS) and micronutrient powder (MNP) to < 5 years children. We used a mixed methods approach through a quantitative survey of 800 households and conducted 18 focused group discussion (FGDs) (with male and female caregivers), 4 FGDs (with Community Health Workers (CHWs)) and 22 key informant interviews (with district stakeholders) to evaluate the community side factors affecting uptake through five parameters: value, acceptability, receipt of supplement, usage and correct dosage.

Results: The findings show that proportionately few beneficiaries consumed the full dose of supplements, despite reasonable knowledge amongst caregivers. Sharing of supplements with other household member was common, and the full monthly stock was usually not received. Qualitative findings suggest that caregivers did not associate food supplements with stunting prevention. WSB was well accepted as an extra ration, LNS was popular due its chocolaty taste and texture, whereas MNP sprinkles were perceived to be of little value. The cultural food practices led to common sharing, whereas interaction with CHWs was minimal for nutrition counselling. Qualitative findings also indicate CHWs related programmatic constraints of low motivation, multi-tasking, inadequate counselling skills and weak supervision.

Conclusion: We conclude that the community acceptability of food supplements does not translate into optimal consumption. Hence a greater emphasis is needed on context specific demand creation and focusing on the supply side constraints with improved logistical planning, enhanced motivation and supervision of community workers with involvement of multiple stakeholders. While, similar studies are needed in varying contexts to help frame universal guidelines.

Trial Registration: ClinicalTrials.gov Identifier: NCT02422953 . Registered on April 22, 2015.
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http://dx.doi.org/10.1186/s12889-020-09103-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7331235PMC
July 2020

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

Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial.

Pediatrics 2019 12 6;144(6). Epub 2019 Nov 6.

Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan.

Background: Ondansetron is an effective antiemetic employed to prevent vomiting in children with gastroenteritis in high-income countries; data from low- and middle-income countries are sparse.

Methods: We conducted a randomized, double-blind, placebo-controlled superiority trial in 2 pediatric emergency departments in Pakistan. Dehydrated children aged 6 to 60 months with ≥1 diarrheal (ie, loose or liquid) stool and ≥1 vomiting episode within the preceding 4 hours were eligible to participate. Participants received a single weight-based dose of oral ondansetron (8-15 kg: 2 mg; >15 kg: 4 mg) or identical placebo. The primary outcome was intravenous administration of ≥20 mL/kg over 4 hours of an isotonic fluid within 72 hours of random assignment.

Results: All 918 (100%) randomly assigned children completed follow-up. Intravenous rehydration was administered to 14.7% (68 of 462) and 19.5% (89 of 456) of those administered ondansetron and placebo, respectively (difference: -4.8%; 95% confidence interval [CI], -9.7% to 0.0%). In multivariable logistic regression analysis adjusted for other antiemetic agents, antibiotics, zinc, and the number of vomiting episodes in the preceding 24 hours, children administered ondansetron had lower odds of the primary outcome (odds ratio: 0.70; 95% CI, 0.49 to 1.00). Fewer children in the ondansetron, relative to the placebo group vomited during the observation period (difference: -12.9%; 95% CI, -18.0% to -7.8%). The median number of vomiting episodes ( < .001) was lower in the ondansetron group.

Conclusions: Among children with gastroenteritis-associated vomiting and dehydration, oral ondansetron administration reduced vomiting and intravenous rehydration use. Ondansetron use may be considered to promote oral rehydration therapy success among dehydrated children in low- and middle-income countries.
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http://dx.doi.org/10.1542/peds.2019-2161DOI Listing
December 2019

Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: A Randomized Controlled Trial.

Ann Emerg Med 2019 03 2;73(3):255-265. Epub 2018 Nov 2.

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

Study Objective: We determine whether single-dose oral ondansetron administration to children with vomiting as a result of acute gastroenteritis without dehydration reduces administration of intravenous fluid rehydration.

Methods: In this 2-hospital, double-blind, placebo-controlled, emergency department-based, randomized trial conducted in Karachi Pakistan, we recruited children aged 0.5 to 5.0 years, without dehydration, who had diarrhea and greater than or equal to 1 episode of vomiting within 4 hours of arrival. Patients were randomly assigned (1:1), through an Internet-based randomization service using a stratified variable-block randomization scheme, to single-dose oral ondansetron or placebo. The primary endpoint was intravenous rehydration (administration of ≥20 mL/kg of an isotonic fluid during 4 hours) within 72 hours of randomization.

Results: Participant median age was 15 months (interquartile range 10 to 26) and 59.4% (372/626) were male patients. Intravenous rehydration use was 12.1% (38/314) and 11.9% (37/312) in the placebo and ondansetron groups, respectively (odds ratio 0.98; 95% confidence interval [CI] 0.60 to 1.61; difference 0.2%; 95% CI of the difference -4.9% to 5.4%). Bolus fluid administration occurred within 72 hours of randomization in 10.8% (34/314) and 10.3% (27/312) of children administered placebo and ondansetron, respectively (odds ratio 0.95; 95% CI 0.56 to 1.59). A multivariable regression model fitted with treatment group and adjusted for antiemetic administration, antibiotics, zinc prerandomization, and vomiting frequency prerandomization yielded similar results (odds ratio 0.91; 95% CI 0.55 to 1.53). There was no interaction between treatment group and age, greater than or equal to 3 stools in the preceding 24 hours, or greater than or equal to 3 vomiting episodes in the preceding 24 hours.

Conclusion: Oral administration of a single dose of ondansetron did not result in a reduction in intravenous rehydration use. In children without dehydration, ondansetron does not improve clinical outcomes.
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http://dx.doi.org/10.1016/j.annemergmed.2018.09.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6390170PMC
March 2019

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

Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial.

Reprod Health 2018 May 31;15(1):104. Epub 2018 May 31.

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

Background: Risk factors known to impact maternal and newborn nutrition and health can exist from adolescence. If an undernourished adolescent girl becomes pregnant, her own health and pregnancy are at an increased risk for adverse outcomes. Offering preconception care from adolescence could provide an opportunity for health and nutrition promotion to improve one's own well-being, as well as future pregnancy outcomes and the health of the next generation.

Methods: The Matiari emPowerment and Preconception Supplementation (MaPPS) Trial is a population-based two-arm, cluster-randomized, controlled trial of life skills building education and multiple micronutrient supplementation provided in a programmatic context to evaluate the impact on pre-identified nutrition and health outcomes among adolescent and young women (15-24 years) in Matiari district Pakistan, and the infants born to them within the context of the trial. The primary aim is to assess the effect of the intervention on the prevalence of low birth weight births (< 2500 g). The intervention includes bi-monthly life skills building education provided from preconception, and supplementation with multiple micronutrients during preconception (twice-weekly), pregnancy (daily), and post-partum (daily to 6 months). The standard of care includes non-regulated community-based health sessions and daily iron and folic acid supplementation during pregnancy. Additional outcome information will also be collected at set time periods. Among participants, these relate to nutrition (anthropometry, nutritional status), morbidity, and mortality. Among infants, these include birth outcomes (stillbirth, preterm birth, length of gestation, small for gestational age, birth defects), anthropometry, morbidity, and mortality.

Discussion: Preconception care from adolescence that includes interventions targeting life skills development and nutrition is suggested to be important to improving the health and nutrition of adolescent and young women and their future offspring. This study is expected to offer insight into providing such an intervention both within a programmatic context and with an extended exposure period prior to conception.

Trial Registration: The MaPPS Trial was registered retrospectively on clinicaltrials.gov (Identifier: NCT03287882 ) on September 19, 2017.
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http://dx.doi.org/10.1186/s12978-018-0545-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984313PMC
May 2018

Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial.

Reprod Health 2018 May 30;15(1):103. Epub 2018 May 30.

Centre for Global Child Health, The Hospital for Sick Children, Toronto, ON, M6S 1S6, Canada.

Background: Adolescence is a critical period for physical and psychological growth and development, and vitamin and mineral requirements are correspondingly increased. Health and health behaviours correspond strongly from adolescence to adulthood. Developing a preconception care package for adolescent and young women in resource-limited settings could serve to empower them to make informed decisions about their nutrition, health, and well-being, as well as function as a platform for the delivery of basic nutrition-related interventions to address undernutrition.

Methods: In this population-based two-arm, cluster-randomized, controlled trial of life skills building education (provided bi-monthly) and multiple micronutrient supplementation (provided twice-weekly; UNIMMAP composition), we aim to evaluate the effectiveness of the intervention on the prevention of anemia (hemoglobin concentration < 12 g/dL) among adolescent and young women (15-24 years) in Matiari district, Pakistan compared to the standard of care. Several secondary objectives related to nutrition (anthropometry [height, weight, middle upper arm circumference (MUAC)], nutritional status [iron, vitamin A, vitamin D]); general health (morbidity, mortality); and empowerment (age at marriage, completion of the 10th grade, use of personal hygienic materials during menstruation) will also be assessed. Participants will be enrolled in the study for a maximum of 2 years.

Discussion: Empowering adolescent and young women with the appropriate knowledge to make informed and healthy decisions will be key to sustained behavioural change throughout the life-course. Although multiple micronutrient deficiencies are known to exist among adolescent and young women in low-resource settings, recommendations on preconception multiple micronutrient supplementation do not exist at this time. This study is expected to offer insight into providing an intervention that includes both education and supplements to non-pregnant adolescent and young women for a prolonged duration of time within the existing public health programmatic context.

Trial Registration: This study is part of the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial. The MaPPS Trial was registered retrospectively on clinicaltrials.gov (Identifier: NCT03287882 ) on September 19, 2017.
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http://dx.doi.org/10.1186/s12978-018-0547-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977744PMC
May 2018

Seroprevalence of anti-polio antibodies in children from polio high risk area of Afghanistan: A cross sectional survey 2017.

Vaccine 2018 04 3;36(15):1921-1924. Epub 2018 Mar 3.

Department of Peadiatrics and Child Health, Aga Khan University, Karachi, Pakistan. Electronic address:

Background: Afghanistan is one of the remaining wild-poliovirus (WPV) endemic countries. We conducted a seroprevalence survey of anti-poliovirus antibodies in Kandahar Province.

Methods: Children in two age groups (6-11 months and 36-48 months) visiting Mirwais hospital in Kandahar for minor ailments unrelated to polio were enrolled. After obtaining informed consent, we collected venous blood and conducted neutralization assay to detect poliovirus neutralizing antibodies.

Results: A total of 420 children were enrolled and 409/420 (97%) were analysed. Seroprevalence to poliovirus type 1 (PV1) was 97% and 100% in the younger and older age groups respectively; it was 71% and 91% for PV2; 93% and 98% for PV3. Age group (RR = 3.6, CI 95% = 2.2-5.6) and place of residence outside of Kandahar city (RR = 1.8, CI 95% = 1.2-2.6) were found to be significant risk factors for seronegativity.

Conclusions: The polio eradication program in Kandahar achieved high serological protection, especially against PV1 and PV3. Lower PV2 seroprevalence in the younger age group is a result of a withdrawal of live type 2 vaccine in 2016 and is expected. Ability to reach all children with poliovirus vaccines is a pre-requisite for achieving poliovirus eradication.
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http://dx.doi.org/10.1016/j.vaccine.2018.02.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5873527PMC
April 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

Seroprevalence of Anti-polio Antibodies in Children From Polio High-risk Areas of Pakistan: A Cross-Sectional Survey 2015-2016.

Pediatr Infect Dis J 2017 Sep;36(9):e230-e236

From the *Department of Peadiatrics and Child Health, Aga Khan University, Karachi, Pakistan; †Polio Eradication Department, World Health Organization, Geneva, Switzerland; and ‡Polio and Picornavirus Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: Pakistan is one of the 3 remaining wild poliovirus endemic countries. We collected sera from children to assess the prevalence of poliovirus antibodies in selected high-risk areas for poliovirus transmission.

Methods: Children in 2 age groups (6-11 and 36-48 months) were randomly selected between November 2015 and March 2016 in 6 areas of Pakistan (Sindh Province: Karachi and Kashmore; Khyber Pakhtunkhwa Province: Peshawar, Bannu and Nowshera; Punjab Province: Faisalabad). After obtaining informed consent, basic demographic and vaccination history data were collected, 1 peripheral venipuncture was obtained, and assays to detect poliovirus (PV)-neutralizing antibodies were performed.

Results: A total of 1301 children were enrolled and had peripheral blood drawn that analyzed. Study subjects were evenly distributed among survey sites and age groups. Anti-polio seroprevalence differed significantly among geographic areas (P < 0.001); in the 6-11 months group, it ranged between 89% and 98%, 58% and 95%, and 74% and 96% for PV serotypes 1, 2 and 3, respectively; in 36-48 months group, it ranged between 99% and 100%, 95% and 100%, and 92% and 100% for PV 1, 2, and 3, respectively. Having received inactivate poliovirus vaccine, malnourishment (stunting) and educational level of parents were found to be associated with presence of anti-polio antibodies.

Conclusion: The polio eradication program achieved overall high serologic protection; however, immunity gaps in young children in the high polio risk areas remain. These gaps enable sustained circulation of wild poliovirus type 1, and pose risk for emergence of vaccine-derived polioviruses. Focusing on the lowest socioeconomic strata of society, where malnutrition is most prevalent, could accelerate poliovirus eradication.
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http://dx.doi.org/10.1097/INF.0000000000001622DOI Listing
September 2017

Early Antibiotic Exposure in Low-resource Settings Is Associated With Increased Weight in the First Two Years of Life.

J Pediatr Gastroenterol Nutr 2017 09;65(3):350-356

*Department of Public Health Sciences †Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA ‡Fogarty International Center, National Institutes of Health, Bethesda, MD §Christian Medical College, Vellore, India ||International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh ¶Institute of Medicine, Tribhuvan University #Walter Reed/Armed Forces Research Institute of Medical Sciences Research Unit, Kathmandu, Nepal **Center for International Health, University of Bergen, Bergen, Norway ††Aga Khan University, Karachi, Pakistan ‡‡Asociación Benéfica PRISMA, Iquitos, Peru §§Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD ||||Haydom Lutheran Hospital, Haydom, Tanzania ¶¶Haukeland University Hospital, Bergen, Norway ##Clinical Research Unit and Institute of Biomedicine, Federal University of Ceara, Fortaleza, Brazil ***Foundation for the National Institutes of Health, Bethesda, MD †††University of Venda, Thohoyandou, South Africa.

Objectives: The potential growth-promoting effects of antibiotics are not well understood among undernourished children in environments with high pathogen exposure. We aimed to assess whether early antibiotic exposure duration and class were associated with growth to 2 years of age across 8 low-resource sites in the MAL-ED birth cohort study.

Methods: We followed 1954 children twice per week from birth to 2 years to record maternally reported antibiotic exposures and measure anthropometry monthly. We estimated the associations between antibiotic exposure before 6 months of age and weight-for-age and length-for-age (LAZ) z scores to 2 years. We assessed the impact of class-specific exposures and duration, and compared these results to effects of antibiotic exposures after 6 months of age.

Results: Antibiotic use before 6 months of age was associated with increased weight from 6 months to 2 years, whereas associations with length were less consistent across sites and antibiotic classes. Compared to unexposed children, 2 or more courses of metronidazole, macrolides, and cephalosporins were associated with adjusted increases in weight-for-age of 0.24 (95% confidence interval (CI): 0.04, 0.43), 0.23 (95% CI: 0.05, 0.42), and 0.19 (95% CI: 0.04, 0.35) from 6 months to 2 years, respectively.

Conclusions: Antibiotic use in low-resource settings was most associated with the ponderal growth of children who had multiple exposures to antibiotics with broad spectrum and anaerobic activity in early infancy. Opportunities for rational and targeted antibiotic therapy in low resource settings may also promote short-term weight gain in children, although longer-term physical growth and metabolic impacts are unknown.
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http://dx.doi.org/10.1097/MPG.0000000000001640DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559187PMC
September 2017

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries.

Bull World Health Organ 2016 Oct 30;94(10):752-758B. Epub 2016 Aug 30.

Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, avenue Appia 20, 1211 Geneva 27, Switzerland .

Objective: To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries.

Methods: We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality.

Findings: Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality.

Conclusion: Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings.
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http://dx.doi.org/10.2471/BLT.15.160945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5043199PMC
October 2016

Cost of management of severe pneumonia in young children: systematic analysis.

J Glob Health 2016 Jun;6(1):010408

Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK; Public Health Foundation of India, New Delhi, India.

Background: Childhood pneumonia is a major cause of childhood illness and the second leading cause of child death globally. Understanding the costs associated with the management of childhood pneumonia is essential for resource allocation and priority setting for child health.

Methods: We conducted a systematic review to identify studies reporting data on the cost of management of pneumonia in children younger than 5 years old. We collected unpublished cost data on non-severe, severe and very severe pneumonia through collaboration with an international working group. We extracted data on cost per episode, duration of hospital stay and unit cost of interventions for the management of pneumonia. The mean (95% confidence interval, CI) and median (interquartile range, IQR) treatment costs were estimated and reported where appropriate.

Results: We identified 24 published studies eligible for inclusion and supplemented these with data from 10 unpublished studies. The 34 studies included in the cost analysis contained data on more than 95 000 children with pneumonia from both low- and-middle income countries (LMIC) and high-income countries (HIC) covering all 6 WHO regions. The total cost (per episode) for management of severe pneumonia was US$ 4.3 (95% CI 1.5-8.7), US$ 51.7 (95% CI 17.4-91.0) and US$ 242.7 (95% CI 153.6-341.4)-559.4 (95% CI 268.9-886.3) in community, out-patient facilities and different levels of hospital in-patient settings in LMIC. Direct medical cost for severe pneumonia in hospital inpatient settings was estimated to be 26.6%-115.8% of patients' monthly household income in LMIC. The mean direct non-medical cost and indirect cost for severe pneumonia management accounted for 0.5-31% of weekly household income. The mean length of stay (LOS) in hospital for children with severe pneumonia was 5.8 (IQR 5.3-6.4) and 7.7 (IQR 5.5-9.9) days in LMIC and HIC respectively for these children.

Conclusion: This is the most comprehensive review to date of cost data from studies on the management of childhood pneumonia and these data should be helpful for health services planning and priority setting by national programmes and international agencies.
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http://dx.doi.org/10.7189/jogh.06.010408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4871066PMC
June 2016

Infection Surveillance Protocol for a Multicountry Population-based Study in South Asia to Determine the Incidence, Etiology and Risk Factors for Infections Among Young Infants of 0 to 59 Days Old.

Pediatr Infect Dis J 2016 May;35(5 Suppl 1):S9-15

From the *Department of Microbiology, Child Health Research Foundation, Dhaka, Bangladesh; †Department of International Health, Johns Hopkins University, Baltimore, Maryland; ‡Department of Pediatrics and Child Health, The Aga Khan University, Karachi, Pakistan; §Department of Epidemiology and Pediatrics, University of Nebraska Medical Center, Omaha, Nebraska; ¶Department of Community Health, Christian Medical College, Vellore, India; ‖Asian Institute of Public Health, Bhubaneswar, Odisha, India; **Centre for Child and Adolescent Health, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh; ††Department of Paediatrics, Hospital for Sick Children, Ontario, Canada; and ‡‡Department of Child and Adolescent Health and Development, World Health Organization, Geneva, Switzerland.

Background: Insufficient knowledge of the etiology and risk factors for community-acquired neonatal infection in low-income countries is a barrier to designing appropriate intervention strategies for these settings to reduce the burden and treatment of young infant infection. To address these gaps, we are conducting the Aetiology of Neonatal Infection in South Asia (ANISA) study among young infants in Bangladesh, India and Pakistan. The objectives of ANISA are to establish a comprehensive surveillance system for registering newborns in study catchment areas and collecting data on bacterial and viral etiology and associated risk factors for infections among young infants aged 0-59 days.

Methods: We are conducting active surveillance in 1 peri-urban and 4 rural communities. During 2 years of surveillance, we expect to enroll an estimated 66,000 newborns within 7 days of their birth and to follow-up them until 59 days of age. Community health workers visit each young infant in the study area 3 times in the first week of life and once a week thereafter. During these visits, community health workers assess the newborns using a clinical algorithm and refer young infants with signs of suspected infection to health care facilities where study physicians reassess them and provide care if needed. On physician confirmation of suspected infection, blood and respiratory specimens are collected and tested to identify the etiologic agent.

Conclusions: ANISA is one of the largest initiatives ever undertaken to understand the etiology of young infant infection in low-income countries. The data generated from this surveillance will help guide evidence-based decision making to improve health care in similar settings.
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http://dx.doi.org/10.1097/INF.0000000000001100DOI Listing
May 2016

Methods Employed in Monitoring and Evaluating Field and Laboratory Systems in the ANISA Study: Ensuring Quality.

Pediatr Infect Dis J 2016 May;35(5 Suppl 1):S39-44

From the *Centre for Child and Adolescent Health, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh; †Child Health Research Foundation, Dhaka, Bangladesh; ‡Centers for Disease Control and Prevention, Atlanta, Georgia; §Department of International Health, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland; ¶The Aga Khan University, Karachi, Pakistan; ‖Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska; **Christian Medical College, Vellore, India; and ††Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.

Background: The Aetiology of Neonatal Infection in South Asia (ANISA) study maintains operations in Bangladesh, India and Pakistan. We developed and deployed a multilayered monitoring system to measure performance indicators of field sites and laboratory operations. This system allows for real-time provision of feedback to study site teams and project stakeholders. The goal of this monitoring and evaluation system is to promote optimal performance and consistency in protocol application at all sites over the course of the study, thereby safeguarding the validity of project findings. This article describes each of the interdependent monitoring layers that were conceptualized, developed and employed by the ANISA coordination team.

Methods: Layers of monitoring include site-level, central and database-related activities along with periodic site visitation. We provide a number of real-world examples of how feedback from the ANISA monitoring system directly informs a number of crucial decisions and course corrections during the project.

Conclusion: The ANISA monitoring system represents a transparent, understandable and practical resource for development of project monitoring systems in complex multisite health research projects.
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May 2016

A systematic review of community-to-facility neonatal referral completion rates in Africa and Asia.

BMC Public Health 2015 Sep 30;15:989. Epub 2015 Sep 30.

Save the Children, 2000 L Street NW, Suite 500, Washington, DC, 20036, USA.

Background: An estimated 2.8 million neonatal deaths occur annually worldwide. The vulnerability of newborns makes the timeliness of seeking and receiving care critical for neonatal survival and prevention of long-term sequelae. To better understand the role active referrals by community health workers play in neonatal careseeking, we synthesize data on referral completion rates for neonates with danger signs predictive of mortality or major morbidity in low- and middle-income countries.

Methods: A systematic review was conducted in May 2014 of the following databases: Medline-PubMed, Embase, and WHO databases. We also searched grey literature. In addition, an investigator group was established to identify unpublished data on newborn referral and completion rates. Inquiries were made to the network of research groups supported by Save the Children's Saving Newborn Lives project and other relevant research groups.

Results: Three Sub-Saharan African and five South Asian studies reported data on community-to-facility referral completion rates. The studies varied on factors such as referral rates, the assessed danger signs, frequency of home visits in the neonatal period, and what was done to facilitate referrals. Neonatal referral completion rates ranged from 34 to 97 %, with the median rate of 74 %. Four studies reported data on the early neonatal period; early neonatal completion rates ranged from 46 to 97 %, with a median of 70 %. The definition of referral completion differed by studies, in aspects such as where the newborns were referred to and what was considered timely completion.

Conclusions: Existing literature reports a wide range of neonatal referral completion rates in Sub-Saharan Africa and South Asia following active illness surveillance. Interpreting these referral completion rates is challenging due to the great variation in study design and context. Often, what qualifies as referral and/or referral completion is poorly defined, which makes it difficult to aggregate existing data to draw appropriate conclusions that can inform programs. Further research is necessary to continue highlighting ways for programs, governments, and policymakers to best aid families in low-resource settings in protecting their newborns from major health consequences.
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http://dx.doi.org/10.1186/s12889-015-2330-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589085PMC
September 2015

Impact of service provision platforms on maternal and newborn health in conflict areas and their acceptability in Pakistan: a systematic review.

Confl Health 2015 22;9:25. Epub 2015 Aug 22.

Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada ; Program for Global Paediatric Research, Hospital for Sick Children, Toronto, ON Canada.

Various models and strategies have been implemented over the years in different parts of the world to improve maternal and newborn health (MNH) in conflict affected areas. These strategies are based on specific needs and acceptability of local communities. This paper has undertaken a systematic review of global and local (Pakistan) information from conflict areas on platforms of health service provision in the last 10 years and information on acceptability from local stakeholders on effective models of service delivery; and drafted key recommendations for improving coverage of health services in conflict affected areas. The literature search revealed ten studies that described MNH service delivery platforms. The results from the systematic review showed that with utilisation of community outreach services, the greatest impacts were observed in skilled birth attendance and antenatal consultation rates. Facility level services, on the other hand, showed that labour room services for an internally displaced population (IDP) improved antenatal care coverage, contraceptive prevalence rate and maternal mortality. Consultative meetings and discussions conducted in Quetta and Peshawar (capitals of conflict affected provinces) with relevant stakeholders revealed that no systematic models of MNH service delivery, especially tailored for conflict areas, are available. During conflict, even previously available services and infrastructure suffered due to various barriers specific to times of conflict and unrest. A number of barriers that hinder MNH services were discussed. Suggestions for improving MNH services in conflict areas were also laid down by participants. The review identified some important steps that can be undertaken to mitigate the effects of conflict on MNH services, which include: improve provision and access to infrastructure and equipment; development and training of healthcare providers; and advocacy at different levels for free access to healthcare services and for the introduction of the programme model in existing healthcare system. The obligation is enormous, however, for a sustainable programme, it is important to work closely with both the IDP and host community, and collaborating with the government and non-government organisations.
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http://dx.doi.org/10.1186/s13031-015-0054-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4546286PMC
August 2015

Impact of a community-based perinatal and newborn preventive care package on perinatal and neonatal mortality in a remote mountainous district in Northern Pakistan.

BMC Pregnancy Childbirth 2015 Apr 30;15:106. Epub 2015 Apr 30.

Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.

Background: There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. We evaluated the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan.

Methods: The package was evaluated using quasi experimental design included promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices. Control areas continued to receive the routine standard health services. The intervention areas received intervention package in addition to the routine standard health services. Outcome measures included changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.

Results: The intervention was implemented in a population of 283324 over a 18 months period. 3200 pregnant women received the intervention. Significant improvements in antenatal care (92% vs 76%, p < .001), TT vaccination (67% vs 47%, p < .001), institutional delivery (85% vs 71%, p < .001), cord application (51% vs 71%, p < .001), delayed bathing (15% vs 43%, p < .001), colostrum administration (83% vs 64%, p < .001), and initiation of breastfeeding within 1 hour after birth (55% vs 40%, p < .001) were seen in intervention areas compared with control areas. Our results indicate significant reductions in mortality rates in intervention areas as compared to control areas from baseline in perinatal mortality rate (from 47.1 to 35.3 per 1000 births, OR 0.62; 95% CI: 0.56-0.69; P 0.02) and neonatal mortality rates (from 26.0 to 22.8 per 1000 live births, 0.58; 95% CI: 0.48-0.68; P 0.03).

Conclusions: The implementation of a set of low cost community-based intervention package within the health system settings in a mountainous region of Pakistan was found to be both feasible and beneficial. The interventions had a significant impact in reduction of the burden of perinatal and neonatal mortality.

Trial Registration: This study is registered, ClinicalTrial.gov NCT02412293 .
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http://dx.doi.org/10.1186/s12884-015-0538-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4446857PMC
April 2015

Geographical and socioeconomic inequalities in women and children's nutritional status in Pakistan in 2011: an analysis of data from a nationally representative survey.

Lancet Glob Health 2015 Apr;3(4):e229-39

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

Background: Pakistan has one of the highest levels of child and maternal undernutrition worldwide, but little information about geographical and socioeconomic inequalities is available. We aimed to analyse anthropometric indicators for childhood and maternal nutrition at a district level in Pakistan and assess the association of nutritional status with food security and maternal and household socioeconomic factors.

Methods: We used data from the 2011 Pakistan National Nutrition Survey, which included anthropometric measurements for 33 638 children younger than 5 years and 24 826 women of childbearing age. We estimated the prevalences of stunting, wasting, and underweight among children and of underweight, overweight, and obesity in women for all 143 districts of Pakistan using a Bayesian spatial technique. We used a mixed-effect linear model to analyse the association of nutritional status with individual and household sociodemographic factors and food security.

Findings: Stunting prevalence in Pakistan's districts ranged between 22% (95% credible interval 19-26) and 76% (69-83); the lowest figures for wasting and underweight were both less than 2·5% and the highest were 42% (34-50) for wasting and 54% (49-59) for underweight. In 106 districts, more women were overweight than were underweight; in 49 of these districts more women were obese than were underweight. Children were better nourished if their mothers were taller or had higher weight, if they lived in wealthier households, and if their mothers had 10 or more years of education. Severe food insecurity was associated with worse nutritional outcomes for both children and women.

Interpretation: We noted large social and geographical inequalities in child and maternal nutrition in Pakistan, masked by national and provincial averages. Pakistan is also beginning to face the concurrent challenge of high burden of childhood undernutrition and overweight and obesity among women of reproductive age. Planning, implementation, and evaluation of programmes for food and nutrition should be based on district-level needs and outcomes.

Funding: Bill & Melinda Gates Foundation, Grand Challenges Canada, UK Medical Research Council.
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http://dx.doi.org/10.1016/S2214-109X(15)70001-XDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365918PMC
April 2015

Demographic, socioeconomic, and health characteristics of the MAL-ED network study site in rural Pakistan.

Clin Infect Dis 2014 Nov;59 Suppl 4:S304-9

Division of Women and Child Health, Aga Khan University, Karachi, Pakistan.

The Pakistan study site of the Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED) cohort study is located in Molhan union council of Naushahro Feroze district in the Sindh province. The study site is located in a rural district, where the majority of the population has an agrarian livelihood. Most families are nuclear families and the average household has 7 persons. More than half the women in the region have no formal education, and the median parity is 6. Only 48%-61% of the households across the district, province, and country have access to an improved toilet facility. Similar to the provincial and national estimates, the district has a low rate of exclusive breastfeeding at 6 months, and the prevalence of prelacteal feeding is high. There is also a high proportion of malnourished children. In addition, the acute respiratory infection and diarrheal illness burden and the mortality rates in children <5 years old in the district are high but comparable with the provincial and national estimates. Overall, the district is representative of rural populations at the regional and national level in terms of demographics, socioeconomic status, and general health and mortality indicators.
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http://dx.doi.org/10.1093/cid/ciu391DOI Listing
November 2014

Immune responses to Vi capsular polysaccharide typhoid vaccine in children 2 to 16 years old in Karachi, Pakistan, and Kolkata, India.

Clin Vaccine Immunol 2014 May 5;21(5):661-6. Epub 2014 Mar 5.

International Vaccine Institute, Seoul, Republic of Korea.

The geometric mean concentration (GMC) and the proportion maintaining a protective level (150 enzyme-linked immunosorbent assay (ELISA) units [ELU]/ml) 2 years following a single dose of 25 μg of injectable Vi capsular polysaccharide typhoid vaccine was measured against that of the control hepatitis A vaccine in children 2 to 16 years old in cluster randomized trials in Karachi and Kolkata. The GMC for the Vi group (1,428 ELU/ml) was statistically significantly different from the GMC of the control hepatitis A vaccine group (86 ELU/ml) after 6 weeks. A total of 117 children (95.1%) in the Vi group and 9 (7.5%) in the hepatitis A group showed a 4-fold rise in Vi IgG antibody concentrations at 6 weeks (P < 0.01). Protective antibody levels remained significantly different between the two groups at 2 years (38% in the Vi vaccine groups and 6% in the hepatitis A group [P < 0.01]). A very small proportion of younger children (2 to 5 years old) maintained protective Vi IgG antibody levels at 2 years, a result that was not statistically significantly different compared to that for the hepatitis A group (38.1% versus 10.5%). The GMCs of the Vi IgG antibody after 2 years were 133 ELU/ml for children 2 to <5 years old and 349 ELU/ml for children 5 to 16 years old. In conclusion, Vi capsular polysaccharide typhoid vaccine is immunogenic in children in settings of South Asia where typhoid is highly endemic. The antibody levels in children who received this vaccine remained higher than those in children who received the control vaccine but were significantly reduced at 2 years of follow-up.
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http://dx.doi.org/10.1128/CVI.00791-13DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4018880PMC
May 2014

Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials.

Lancet Infect Dis 2014 Feb 28;14(2):119-29. Epub 2013 Nov 28.

Novartis Vaccines Institute for Global Health, Siena, Italy. Electronic address:

Background: Typhoid vaccination is a public health priority in developing countries where young children are greatly affected by typhoid fever. Because present vaccines are not recommended for children younger than 2 years, the Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM197) for infant immunisation. We aimed to assess the immunogenicity and safety of Vi-CRM197 in participants of various ages in endemic countries in south and southeast Asia.

Methods: We did two randomised, observer-blind, age de-escalation, phase 2 trials at two sites in Pakistan and India (study A), and at one site in the Philippines (study B), between March 2, 2011, and Aug 9, 2012. Adults aged 18-45 years, children aged 24-59 months, older infants aged 9-12 months, and infants aged 6-8 weeks were randomly assigned (1:1) with a computer-generated randomisation list (block size of four) to receive either 5 μg Vi-CRM197 or 25 μg Vi-polysaccharide vaccine (or 13-valent pneumococcal conjugate vaccine in children younger than 2 years). Both infant populations received Vi-CRM197 concomitantly with vaccines of the Expanded Programme on Immunization (EPI), according to WHO schedule. With the exception of designated study site personnel responsible for vaccine preparation, study investigators, those assessing outcomes, and data analysts were masked to treatment allocation. We specified no a-priori null hypothesis for the immunogenicity or safety objectives and all analyses were descriptive. Analyses were by modified intention-to-treat. These studies are registered with ClinicalTrials.gov, numbers NCT01229176 and NCT01437267.

Findings: 320 participants were enrolled and vaccinated in the two trials: 200 in study A (all age groups) and 120 in study B (children and infants only), of whom 317 (99%) were included in the modified intention-to-treat analysis. One dose of Vi-CRM197 significantly increased concentrations of anti-Vi antibody in adults (from 113 U/mL [95% CI 67-190] to 208 U/mL [117-369]), children (201 U/mL [138-294] to 368 U/mL [234-580]), and older infants (179 U/mL [129-250] to 249 U/mL [130-477]). However, in children and older infants, a second dose of conjugate vaccine had no incremental effect on antibody titres and, at all ages, concentrations of antibodies increased substantially 6 months after vaccination (from 55 U/mL [33-94] to 63 U/mL [35-114] in adults, from 23 U/mL [15-34] to 51 U/mL [34-76] in children, and from 21 U/mL [14-31] to 22 U/mL [14-33] in older infants). Immune response in infants aged 6-8 weeks was lower than that in older participants and, 6 months after third vaccination, antibody concentrations were significantly higher than pre-vaccination concentrations in Filipino (21 U/mL [16-28] vs 2.88 U/mL [1.95-4.25]), but not Pakistani (3.76 U/mL [2.77-5.08] vs 2.77 U/mL [2.1-3.66]), infants. Vi-CRM197 was safe and well tolerated and did not induce any significant interference with EPI vaccines. No deaths or vaccine-related serious adverse events were reported throughout the studies.

Interpretation: Vi-CRM197 is safe and immunogenic in endemic populations of all ages. Given at 9 months of age, concomitantly with measles vaccine, Vi-CRM197 shows a promise for potential inclusion in EPI schedules of countries endemic for typhoid. An apparent absence of booster response and a reduction in antibody titres 6 months after immunisation should be further investigated, but data show that an immunogenic typhoid vaccine can be safely delivered to infants during EPI visits recommended by WHO.

Funding: Sclavo Vaccines Association and Regione Toscana.
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http://dx.doi.org/10.1016/S1473-3099(13)70241-XDOI Listing
February 2014

Validation of verbal autopsy tool for ascertaining the causes of stillbirth.

PLoS One 2013 9;8(10):e76933. Epub 2013 Oct 9.

Division of Women & Child Health, Aga Khan University, Karachi, Pakistan.

Objective: To assess performance of the WHO revised verbal autopsy tool for ascertaining the causes of still birth in comparison with reference standard cause of death ascertained by standardized clinical and supportive data.

Methods: All stillbirths at a tertiary hospital in Karachi, Pakistan were prospectively recruited into study from August 2006- February 2008. The reference standard cause of death was established by two senior obstetricians within 48 hours using the ICD coding system. Verbal autopsy interviews using modified WHO tool were conducted by trained health workers within 2- 6 weeks of still birth and the cause of death was assigned by second panel of obstetricians. The performance was assessed in terms of sensitivity, specificity and Kappa.

Results: There were 204 still births. Of these, 80.8% of antepartum and 50.5% of intrapartum deaths were correctly diagnosed by verbal autopsy. Sensitivity of verbal autopsy was highest 68.4%, (95%CI: 46-84.6) for congenital malformation followed by obstetric complication 57.6%, (95%CI: 25-84.2). The specificity for all major causes was greater than 90%. The level of agreement was high (kappa=0.72) for anomalies and moderate (k=0.4) for all major causes of still birth, except asphyxia.

Conclusion: Our results suggest that verbal autopsy has reasonable validity in identifying and discriminating between causes of stillbirth in Pakistan. On the basis of these findings, we feel it has a place in resource constrained areas to inform strategic planning and mobilization of resources to attain Millennium Development Goals.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0076933PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3793932PMC
June 2014

Evaluation of health workforce competence in maternal and neonatal issues in public health sector of Pakistan: an Assessment of their training needs.

BMC Health Serv Res 2010 Nov 27;10:319. Epub 2010 Nov 27.

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

Background: More than 450 newborns die every hour worldwide, before they reach the age of four weeks (neonatal period) and over 500,000 women die from complications related to childbirth. The major direct causes of neonatal death are infections (36%), Prematurity (28%) and Asphyxia (23%). Pakistan has one of the highest perinatal and neonatal mortality rates in the region and contributes significantly to global neonatal mortality. The high mortality rates are partially attributable to scarcity of trained skilled birth attendants and paucity of resources. Empowerment of health care providers with adequate knowledge and skills can serve as instrument of change.

Methods: We carried out training needs assessment analysis in the public health sector of Pakistan to recognize gaps in the processes and quality of MNCH care provided. An assessment of Knowledge, Attitude, and Practices of Health Care Providers on key aspects was evaluated through a standardized pragmatic approach. Meticulously designed tools were tested on three tiers of health care personnel providing MNCH in the community and across the public health care system. The Lady Health Workers (LHWs) form the first tier of trained cadre that provides MNCH at primary care level (BHU) and in the community. The Lady Health Visitor (LHVs), Nurses, midwives) cadre follow next and provide facility based MNCH care at secondary and tertiary level (RHCs, Taluka/Tehsil, and DHQ Hospitals). The physician/doctor is the specialized cadre that forms the third tier of health care providers positioned in secondary and tertiary care hospitals (Taluka/Tehsil and DHQ Hospitals). The evaluation tools were designed to provide quantitative estimates across various domains of knowledge and skills. A priori thresholds were established for performance rating.

Results: The performance of LHWs in knowledge of MNCH was good with 30% scoring more than 70%. The Medical officers (MOs), in comparison, performed poorly in their knowledge of MNCH with only 6% scoring more than 70%. All three cadres of health care providers performed poorly in the resuscitation skill and only 50% were able to demonstrate steps of immediate newborn care. The MOs performed far better in counselling skills compare to the LHWs. Only 50 per cent of LHWs could secure competency scale in this critical component of skills assessment.

Conclusions: All three cadres of health care providers performed well below competency levels for MNCH knowledge and skills. Standardized training and counselling modules, tailored to the needs and resources at district level need to be developed and implemented. This evaluation highlighted the need for periodic assessment of health worker training and skills to address gaps and develop targeted continuing education modules. To achieve MDG4 and 5 goals, it is imperative that such deficiencies are identified and addressed.
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http://dx.doi.org/10.1186/1472-6963-10-319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3012669PMC
November 2010