Publications by authors named "Sangappa M Dhaded"

26 Publications

  • Page 1 of 1

Maternal and Fetal Vascular Lesions of Malperfusion in the Placentas Associated with Fetal and Neonatal Death: Results of a Prospective Observational Study.

Am J Obstet Gynecol 2021 Jun 7. Epub 2021 Jun 7.

Columbia University, New York NY USA.

Background: Fetal death, one of the major adverse pregnancy outcomes, is especially common in low and middle-income countries. Placental lesions may play an important role in the etiology of fetal and possibly neonatal death. Prior research relating placental lesions to fetal death causation was often hindered by the lack of agreement on a placental classification scheme. The Amsterdam Consensus statement, published in 2016, focused attention on malperfusions in the maternal and fetal placental circulations.

Objectives: Our purpose was to investigate the relationships of placental maternal vascular (MVM) and fetal vascular malperfusion (FVM) to fetal and neonatal death with a focus on the most important maternal clinical conditions in the pathway to fetal and neonatal death; maternal hypertension, antepartum haemorrhage and decreased fetal growth.

Study Design: This was a prospective, observational cohort study conducted at two Asian sites. Data collected included clinical history, gross and histologic evaluation of the placenta, and a number of other investigations to determine cause of death. The placenta was evaluated at both sites using the Amsterdam Consensus framework. We estimated the risk of placental MVM and FVM among fetal and neonatal deaths.

Results: Between July 2018 and January 2020 in India and Pakistan, 814 women with a fetal death, 618 with a preterm live birth and subsequent neonatal death, and 201 term live births, all with a placenta available for study, provided consent. The prevalence of MVM was higher in placentas of fetal deaths (58.4%) and preterm neonatal deaths (31.1%) compared to the term live births (15.4%). Adjusting for site, MVM had a RR of 3.88 (95% CI 2.70-5.59) among fetal deaths vs. term live births and a RR of 2.07 (95% CI 1.41-3.02) for preterm neonatal deaths vs. term live births. Infarcts and distal villous hypoplasia were the most common histological components of MVM. FVM was found less frequently in the placentas of fetal deaths (19.0%) than was MVM (58.4%). However, there were higher frequencies of FVM in fetal death placentas (19.0%) than in placentas from neonatal deaths (8.3%) or in the term live birth placentas (5.0%). Adjusting for site, FVM had a RR of 4.09 (95% CI 2.15-7.75) among fetal deaths vs. term live births and RR 1.77 (95% CI 0.90-3.49) for preterm neonatal deaths vs. term live births. There was a higher incidence of MVM in cases of maternal hypertension (71.4%), SGA (69.9%) and antepartum hemorrhage (59.1%) compared to the incidence of MVM in fetal deaths with none of these conditions (43.3%). There were no significant differences in the occurrence of FVM among the four clinical categories.

Conclusion(s): Histological examination of the placenta, especially for malperfusion disorders, is crucial in elucidating pathways to fetal death and likely for neonatal death in preterm infants. Possibly more important is the potential to focus on placental MVM and FVM during pregnancy as a means to identify fetuses at risk and to reduce the risk of fetal death by early delivery. It is our additional hope that the increased risk of fetal and neonatal death in these pregnancies can be reduced by development of an intervention to reduce the likelihood of developing MVM and/or FVM in the first place.
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http://dx.doi.org/10.1016/j.ajog.2021.06.001DOI Listing
June 2021

Gender variations in neonatal and early infant mortality in India and Pakistan: a secondary analysis from the Global Network Maternal Newborn Health Registry.

Reprod Health 2020 Dec 17;17(Suppl 3):178. Epub 2020 Dec 17.

Thomas Jefferson University, Philadelphia, PA, USA.

Background: To determine the gender differences in neonatal mortality, stillbirths, and perinatal mortality in south Asia using the Global Network data from the Maternal Newborn Health Registry.

Methods: This study is a secondary analysis of prospectively collected data from the three south Asian sites of the Global Network. The maternal and neonatal demographic, clinical characteristics, rates of stillbirths, early neonatal mortality (1-7 days), late neonatal mortality (8-28 days), mortality between 29-42 days and the number of infants hospitalized after birth were compared between the male and female infants.

Results: Between 2010 and 2018, 297,509 births [154,790 males (52.03%) and 142,719 females (47.97%)] from two Indian sites and one Pakistani site were included in the analysis [288,859 live births (97.1%) and 8,648 stillbirths (2.9%)]. The neonatal mortality rate was significantly higher in male infants (33.2/1,000 live births) compared to their female counterparts (27.4/1,000, p < 0.001). The rates of stillbirths (31.0 vs. 26.9/1000 births) and early neonatal mortality (27.1 vs 21.6/1000 live births) were also higher in males. However, there were no significant differences in late neonatal mortality (6.3 vs. 5.9/1000 live births) and mortality between 29-42 days (2.1 vs. 1.9/1000 live births) between the two groups. More male infants were hospitalized within 42 days after birth (1.8/1000 vs. 1.3/1000 live births, p < 0.001) than females.

Conclusion: The risks of stillbirths, and early neonatal mortality were higher among male infants than their female counterparts. However, there was no gender difference in mortality after 7 days of age. Our results highlight the importance of stratifying neonatal mortality into early and late neonatal period to better understand the impact of gender on neonatal mortality. The information from this study will help in developing strategies and identifying measures that can reduce differences in sex-specific mortality.
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http://dx.doi.org/10.1186/s12978-020-01028-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745348PMC
December 2020

Why are the Pakistani maternal, fetal and newborn outcomes so poor compared to other low and middle-income countries?

Reprod Health 2020 Dec 17;17(Suppl 3):190. Epub 2020 Dec 17.

Department of Obstetrics and Gynecology, Columbia University School of Medicine, New York, NY, USA.

Background: Pakistan has among the poorest pregnancy outcomes worldwide, significantly worse than many other low-resource countries. The reasons for these differences are not clear. In this study, we compared pregnancy outcomes in Pakistan to other low-resource countries and explored factors that might help explain these differences.

Methods: The Global Network (GN) Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya, Zambia). Study staff enroll women in early pregnancy and follow-up soon after delivery and at 42 days to ascertain delivery, neonatal, and maternal outcomes. We analyzed the maternal mortality ratios (MMR), neonatal mortality rates (NMR), stillbirth rates, and potential explanatory factors from 2010 to 2018 across the GN sites.

Results: From 2010 to 2018, there were 91,076 births in Pakistan and 456,276 births in the other GN sites combined. The MMR in Pakistan was 319 per 100,000 live births compared to an average of 124 in the other sites, while the Pakistan NMR was 49.4 per 1,000 live births compared to 20.4 in the other sites. The stillbirth rate in Pakistan was 53.5 per 1000 births compared to 23.2 for the other sites. Preterm birth and low birthweight rates were also substantially higher than the other sites combined. Within weight ranges, the Pakistani site generally had significantly higher rates of stillbirth and neonatal mortality than the other sites combined, with differences increasing as birthweights increased. By nearly every measure, medical care for pregnant women and their newborns in the Pakistan sites was worse than at the other sites combined.

Conclusion: The Pakistani pregnancy outcomes are much worse than those in the other GN sites. Reasons for these poorer outcomes likely include that the Pakistani sites' reproductive-aged women are largely poorly educated, undernourished, anemic, and deliver a high percentage of preterm and low-birthweight babies in settings of often inadequate maternal and newborn care. By addressing the issues highlighted in this paper there appears to be substantial room for improvements in Pakistan's pregnancy outcomes.
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http://dx.doi.org/10.1186/s12978-020-01023-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745345PMC
December 2020

Neonatal deaths in rural Karnataka, India 2014-2018: a prospective population-based observational study in a low-resource setting.

Reprod Health 2020 Nov 30;17(Suppl 2):161. Epub 2020 Nov 30.

Women's and Children's Health Research Unit JN Medical College, KLE Academy of Higher Education and Research Belagavi, Belagavi, Karnataka, India.

Background: Neonatal mortality causes a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC).

Methods: We undertook a prospective, population-based research study of pregnant women residing in defined geographic areas in the Karnataka State of India, a research site of the Global Network for Women's and Children's Health Research. Study staff collected demographic and health care characteristics on eligible women enrolled with neonatal outcomes obtained at delivery and day 28. Cause of neonatal mortality at day 28 was assigned by algorithm using prospectively defined variables.

Results: From 2014 to 2018, the neonatal mortality rate was 24.5 per 1,000 live births. The cause of the 28-day neonatal deaths was attributed to prematurity (27.9%), birth asphyxia (25.1%), infection (23.7%) and congenital anomalies (18.4%). Four or more antenatal care (ANC) visits was associated with a lower risk of neonatal death compared to fewer ANC visits. In the adjusted model, compared to liveborn infants ≥ 2500 g, infants born weighing < 1000 g RR for mortality was 25.6 (95%CI 18.3, 36.0), for 1000-1499 g infants the RR was 19.8 (95% CI 14.2, 27.5) and for 1500-2499 g infants the RR was 3.1 (95% CI 2.7, 3.6). However, more than one-third (36.8%) of the deaths occurred among infants with a birthweight ≥ 2500 g. Infants born preterm (< 37 weeks) were also at higher risk for 28-day mortality (RR 7.9, 95% CI 6.9, 9.0) compared to infants ≥ 37 weeks. A one-week decrease in gestational age at delivery was associated with a higher risk of mortality with a RR of 1.3 (95% CI 1.3, 1.3). More than 70% of all the deliveries occurred at a hospital. Among infants who died, 50.3% of the infants had received bag/mask ventilation, 47.3% received antibiotics, and 55.6% received oxygen.

Conclusions: Consistent with prior research, the study found that infants who were preterm and low-birth weight remained at highest risk for 28-day neonatal mortality in India. Although most of births now occur within health facilities, a substantial proportion are not receiving basic life-saving interventions. Further efforts to understand the impact of care on infant outcomes are needed. Study registration The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.
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http://dx.doi.org/10.1186/s12978-020-01014-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7708103PMC
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

Growth from Birth Through Six Months for Infants of Mothers in the "Women First" Preconception Maternal Nutrition Trial.

J Pediatr 2021 02 18;229:199-206.e4. Epub 2020 Sep 18.

RTI International, Durham, NC.

Objective: To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age.

Study Design: The Women First trial was a multicountry, individually randomized clinical trial that compared the impact of maternal nutrition supplementation initiated preconception (Arm 1) vs at ∼11 weeks of gestation (Arm 2), vs no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were in Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age z scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates.

Results: Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI 0.15-0.35; P < .001) and 0.19 (95% CI 0.09-0.28; P < .001), respectively. Compared with Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <-2) were lower for Arms 1 and 2: 0.76 (0.66-0.87; P < .001) and 0.77 (0.67-0.88; P < .001), respectively.

Conclusions: Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition before conception and in the early phase of gestation.

Trial Registration: ClinicalTrials.gov: NCT01883193.
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http://dx.doi.org/10.1016/j.jpeds.2020.09.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855785PMC
February 2021

Preconception nutrition intervention improved birth length and reduced stunting and wasting in newborns in South Asia: The Women First Randomized Controlled Trial.

PLoS One 2020 29;15(1):e0218960. Epub 2020 Jan 29.

Pediatric Nutrition, University of Colorado School of Medicine, Aurora, Colorado, United States of America.

South Asia has >50% of the global burden of low birth weight (LBW). The objective was to determine the extent to which maternal nutrition interventions commenced before conception or in the 1st trimester improved fetal growth in this region. This was a secondary analysis of combined newborn anthropometric data for the South Asian sites (India and Pakistan) in the Women First Preconception Maternal Nutrition Trial. Participants were 972 newborn of mothers who were poor, rural, unselected on basis of nutritional status, and had been randomized to receive a daily lipid-based micronutrient supplement commencing ≥3 months prior to conception (Arm 1), in the 1st trimester (Arm 2), or not at all (Arm 3). An additional protein-energy supplement was provided if BMI <20 kg/m2 or gestational weight gain was less than guidelines. Gestational age was established in the 1st trimester and newborn anthropometry obtained <48-hours post-delivery. Mean differences at birth between Arm 1 vs. 3 were length +5.3mm and weight +89g. Effect sizes (ES) and relative risks (RR) with 95% CI for Arm 1 vs. 3 were: length-for-age Z-score (LAZ) +0.29 (0.11-0.46, p = 0.0011); weight-for-age Z-score (WAZ) +0.22 (0.07-0.37, p = 0.0043); weight-to-length-ratio-for-age Z-score (WLRAZ) +0.27 (0.06-0.48, p = 0.0133); LAZ<-2, 0.56 (0.38-0.82, p = 0.0032); WAZ <-2, 0.68 (0.53-0.88, p = 0.0028); WLRAZ <-2, 0.76 (0.64-0.89, p = 0.0011); small-for-gestational-age (SGA), 0.74 (0.66-0.83, p<0.0001); low birth weight 0.81 (0.66-1.00, p = 0.0461). For Arm 2 vs. 3, LAZ, 0.21 (0.04-0.38); WAZ <-2, 0.70 (0.53-0.92); and SGA, 0.88 (0.79-0.97) were only marginally different. ES or RR did not differ for preterm birth for either Arm 1 vs. 3 or 2 vs. 3. In conclusion, point estimates for both continuous and binary anthropometric outcomes were consistently more favorable when maternal nutrition supplements were commenced ≥3 months prior to conception indicating benefits to fetal growth of improving women's nutrition in this population.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218960PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988936PMC
March 2020

Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial.

Nutrients 2019 Oct 21;11(10). Epub 2019 Oct 21.

Section of Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA.

The objective of this secondary analysis was to identify maternal characteristics that modified the effect of maternal supplements on newborn size. Participants included 1465 maternal-newborn dyads in Guatemala, India, and Pakistan. Supplementation commenced before conception (Arm 1) or late 1st trimester (Arm 2); Arm 3 received usual care. Characteristics included body mass index (BMI), stature, anemia, age, education, socio-economic status (SES), parity, and newborn sex. Newborn outcomes were -scores for length (LAZ), weight (WAZ), and weight to length ratio-for-age (WLRAZ). Mixed-effect regression models included treatment arm, effect modifier, and arm * effect modifier interaction as predictors, controlling for site, characteristics, and sex. Parity (para-0 vs. para ≥1), anemia (anemia/no anemia), and sex were significant effect modifiers. Effect size (95% CI) for Arm 1 vs. 3 was larger for para-0 vs. ≥1 for all outcomes (LAZ 0.56 (0.28, 0.84, < 0.001); WAZ 0.45 (0.20, 0.07, < 0.001); WLRAZ 0.52 (0.17, 0.88, < 0.01) but only length for Arm 2 vs. 3. Corresponding effects for para ≥1 were >0.02. Arm 3 -scores were all very low for para-0, but not para ≥1. Para-0 and anemia effect sizes for Arm 1 were > Arm 2 for WAZ and WLRAZ, but not LAZ. Arm 1 and 2 had higher WAZ for newborn boys vs. girls. Maternal nulliparity and anemia were associated with impaired fetal growth that was substantially improved by nutrition intervention, especially when commenced prior to conception.
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http://dx.doi.org/10.3390/nu11102534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6835723PMC
October 2019

Different Gut Microbial Profiles in Sub-Saharan African and South Asian Women of Childbearing Age Are Primarily Associated With Dietary Intakes.

Front Microbiol 2019 14;10:1848. Epub 2019 Aug 14.

Section of Nutrition, Department of Pediatrics, University of Colorado Denver, Aurora, CO, United States.

Background: To compare and characterize the gut microbiota in women of childbearing age from sub-Saharan Africa (the Democratic Republic of the Congo, DRC) and South Asia (India), in relation to dietary intakes.

Methods: Women of childbearing age were recruited from rural DRC and India as part of the Women First (WF) preconception maternal nutrition trial. Findings presented include fecal 16S rRNA gene-based profiling of women in the WF trial from samples obtained at the time of randomization, prior to initiation of nutrition intervention and to conception.

Results: Stool samples were collected from 217 women (DRC = 117; India = 100). Alpha diversity of the gut microbiota was higher in DRC than in India (Chao1: 91 ± 11 vs. 82 ± 12, = 6.58E-07). The gut microbial community structure was not significantly affected by any demographical or environmental variables, such as maternal BMI, education, and water source. , and were at relatively high abundance without differences between sites. was higher in India (4.95 ± 1.0%) than DRC (0.3 ± 0.1%; = 2.71E-27), as was (DRC: 0.2 ± 0.0%; India: 1.2 ± 0.1%; = 2.39E-13) and (DRC: 6.0 ± 1.7%; India: 8.4 ± 2.9%; = 6.51E-7). was higher in DRC (2.3 ± 0.7%) than in India (1.8 ± 0.4%; = 3.24E-5) and was positively associated with consumption of flesh foods. was positively associated with dairy intake in India and fish/insects in DRC. was positively associated with vitamin A-rich fruits and vegetables. Overall, these observations were consistent with India being primarily vegetarian with regular fermented dairy consumption and DRC regularly consuming animal-flesh foods.

Conclusion: Consumption of animal-flesh foods and fermented dairy foods were independently associated with the gut microbiota while demographic variables were not, suggesting that diet may have a stronger association with microbiota than demographic characteristics.
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http://dx.doi.org/10.3389/fmicb.2019.01848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6702451PMC
August 2019

A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial.

Am J Clin Nutr 2019 02;109(2):457-469

Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO.

Background: Reported benefits of maternal nutrition supplements commenced during pregnancy in low-resource populations have typically been quite limited.

Objectives: This study tested the effects on newborn size, especially length, of commencing nutrition supplements for women in low-resource populations ≥3 mo before conception (Arm 1), compared with the same supplement commenced late in the first trimester of pregnancy (Arm 2) or not at all (control Arm 3).

Methods: Women First was a 3-arm individualized randomized controlled trial (RCT). The intervention was a lipid-based micronutrient supplement; a protein-energy supplement was also provided if maternal body mass index (kg/m2) was <20 or gestational weight gain was less than recommendations. Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan. The primary outcome was length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery. Because gestational ages were unavailable in DRC, outcomes were determined for all 4 sites from WHO newborn standards (non-gestational-age-adjusted, NGAA) as well as INTERGROWTH-21st fetal standards (3 sites, gestational age-adjusted, GAA).

Results: A total of 7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes. Mean LAZ and other outcomes did not differ between Arm 1 and Arm 2 using either NGAA or GAA. Mean LAZ (NGAA) for Arm 1 was greater than for Arm 3 (effect size: +0.19; 95% CI: 0.08, 0.30, P = 0.0008). For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively). Rates of preterm birth did not differ among arms.

Conclusions: In low-resource populations, benefits on fetal growth-related birth outcomes were derived from nutrition supplements commenced before conception or late in the first trimester. This trial was registered at clinicaltrials.gov as NCT01883193.
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http://dx.doi.org/10.1093/ajcn/nqy228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6367966PMC
February 2019

Food insecurity and nutritional status of preconception women in a rural population of North Karnataka, India.

Reprod Health 2018 Jun 22;15(Suppl 1):90. Epub 2018 Jun 22.

Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.

Background: As per the World Health Organization, the nutritional status of women of reproductive age is important, as effects of undernutrition are propagated to future generations. More than one-third of Indian women in the reproductive age group are in a state of chronic nutritional deficiency during the preconception period leading to poor health and likely resulting in low birth weight babies. This study was aimed to assess the food insecurity and nutritional status of preconception women in a rural population of north Karnataka.

Methods: A total of 770 preconception women were enrolled across a district in Karnataka from selected primary health centre areas by a cluster sampling method. Data on socioeconomic status, food insecurity and obstetric history were collected by trained research assistants, interviewing women at home. In half of the participants, a 1 day 24 -hour dietary recalls were conducted by dietary assistants to assess the dietary intakes. Anthropometric measurements and haemoglobin estimation were carried out at the health centres.

Results: In the present study, a majority of the participants (64.8%) belonged to the lower socio-economic classes and the prevalence of food insecurity was 27.4%. A majority of the participants had mild (15.5%) to moderate (78.6%) anaemia. About one-third of the participants (36.6%) were underweight. Significant associations were found between socio-economic status and anaemia (p = 0.0006) and between food insecurity and anaemia (p = 0.0001).

Conclusion: The nutritional status of preconception women was poor and anemia was more prevalent in low-socioeconomic and food insecure population.
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http://dx.doi.org/10.1186/s12978-018-0535-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019991PMC
June 2018

Trends and determinants of stillbirth in developing countries: results from the Global Network's Population-Based Birth Registry.

Reprod Health 2018 Jun 22;15(Suppl 1):100. Epub 2018 Jun 22.

Columbia University Medical Center, New York, NY, USA.

Background: Stillbirth rates remain high, especially in low and middle-income countries, where rates are 25 per 1000, ten-fold higher than in high-income countries. The United Nations' Every Newborn Action Plan has set a goal of 12 stillbirths per 1000 births by 2030 for all countries.

Methods: From a population-based pregnancy outcome registry, including data from 2010 to 2016 from two sites each in Africa (Zambia and Kenya) and India (Nagpur and Belagavi), as well as sites in Pakistan and Guatemala, we evaluated the stillbirth rates and rates of annual decline as well as risk factors for 427,111 births of which 12,181 were stillbirths.

Results: The mean stillbirth rates for the sites were 21.3 per 1000 births for Africa, 25.3 per 1000 births for India, 56.9 per 1000 births for Pakistan and 19.9 per 1000 births for Guatemala. From 2010 to 2016, across all sites, the mean stillbirth rate declined from 31.7 per 1000 births to 26.4 per 1000 births for an average annual decline of 3.0%. Risk factors for stillbirth were similar across the sites and included maternal age < 20 years and age > 35 years. Compared to parity 1-2, zero parity and parity > 3 were both associated with increased stillbirth risk and compared to women with any prenatal care, women with no prenatal care had significantly increased risk of stillbirth in all sites.

Conclusions: At the current rates of decline, stillbirth rates in these sites will not reach the Every Newborn Action Plan goal of 12 per 1000 births by 2030. More attention to the risk factors and treating the causes of stillbirths will be required to reach the Every Newborn Action Plan goal of stillbirth reduction.

Trial Registration: NCT01073475 .
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http://dx.doi.org/10.1186/s12978-018-0526-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019981PMC
June 2018

Early pregnancy loss in Belagavi, Karnataka, India 2014-2017: a prospective population-based observational study in a low-resource setting.

Reprod Health 2018 Jun 22;15(Suppl 1):95. Epub 2018 Jun 22.

Women's and Children's Health Research Unit, J N Medical College, KLE Academy of Higher Education and Research, Belagavi, Karnataka, India.

Background: The prevalence of early pregnancy loss through miscarriage and medically terminated pregnancy (MTP) is largely unknown due to lack of early registration of pregnancies in most regions, and especially in low- and middle-income countries. Understanding the rates of early pregnancy loss as well as the characteristics of pregnant women who experience miscarriage or MTP can assist in better planning of reproductive health needs of women.

Methods: A prospective, population-based study was conducted in Belagavi District, south India. Using an active surveillance system of women of childbearing age, all women were enrolled as soon as possible during pregnancy. We evaluated rates and risk factors of miscarriage and MTP between 6 and 20 weeks gestation as well as rates of stillbirth and neonatal death. A hypothetical cohort of 1000 women pregnant at 6 weeks was created to demonstrate the impact of miscarriage and MTP on pregnancy outcome.

Results: A total of 30,166 women enrolled from 2014 to 2017 were included in this analysis. The rate of miscarriage per 1000 ongoing pregnancies between 6 and 8 weeks was 115.3, between 8 and 12 weeks the miscarriage rate was 101.9 per 1000 ongoing pregnancies and between 12 and 20 weeks the miscarriage rate was 60.3 per 1000 ongoing pregnancies. For those periods, the MTP rate was 40.2, 45.4, and 48.3 per 1000 ongoing pregnancies respectively. The stillbirth rate was 26/1000 and the neonatal mortality rate was 24/1000. The majority of miscarriages (96.6%) were unattended and occurred at home. The majority of MTPs occurred in a hospital and with a physician in attendance (69.6%), while 20.7% of MTPs occurred outside a health facility. Women who experienced a miscarriage were older and had a higher level of education but were less likely to be anemic than those with an ongoing pregnancy at 20 weeks. Women with MTP were older, had a higher level of education, higher parity, and higher BMI, compared to those with an ongoing pregnancy, but these results were not consistent across gestational age periods.

Conclusions: Of women with an ongoing pregnancy at 6 weeks, about 60% will have a living infant at 28 days of age. Two thirds of the losses will be spontaneous miscarriages and one third will be secondary to a MTP. High maternal age and education were the risk factors associated with miscarriage and MTP.

Trial Registration: The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475 .
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http://dx.doi.org/10.1186/s12978-018-0525-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019989PMC
June 2018

The Relationship between Body Mass Index in Pregnancy and Adverse Maternal, Perinatal, and Neonatal Outcomes in Rural India and Pakistan.

Am J Perinatol 2018 07 24;35(9):844-851. Epub 2018 Jan 24.

Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania.

Objective: The objective of this study was to describe the relationship between early pregnancy body mass index (BMI) and maternal, perinatal, and neonatal outcomes in rural India and Pakistan.

Study Design: In a prospective, population-based pregnancy registry implemented in communities in Thatta, Pakistan and Nagpur and Belagavi, India, we obtained women's BMI prior to 12 weeks' gestation (categorized as underweight, normal, overweight, and obese following World Health Organization criteria). Outcomes were assessed 42 days postpartum.

Results: The proportion of women with an adverse maternal outcome increased with increasing maternal BMI. Less than one-third of nonoverweight/nonobese women, 47.2% of overweight women, and 56.0% of obese women experienced an adverse maternal outcome. After controlling for site, maternal age and parity, risks of hypertensive disease/severe preeclampsia/eclampsia, cesarean/assisted delivery, and antibiotic use were higher among women with higher BMIs. Overweight women also had significantly higher risk of perinatal and early neonatal mortality compared with underweight/normal BMI women. Overweight women had a significantly higher perinatal mortality rate.

Conclusion: High BMI in early pregnancy was associated with increased risk of adverse maternal, perinatal, and neonatal outcomes in rural India and Pakistan. These findings present an opportunity to inform efforts for women to optimize weight prior to conception to improve pregnancy outcomes.
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http://dx.doi.org/10.1055/s-0037-1621733DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6233294PMC
July 2018

Associations between feeding practices and growth and neurodevelopmental outcomes at 36 months among children living in low- and low-middle income countries who participated in the BRAIN-HIT trial.

BMC Nutr 2018 25;4(1). Epub 2018 Apr 25.

Department of Pediatrics/Division of Neonatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Background: Feeding practices over the first several years of a child's life can critically influence development. The purpose of this study was to examine associations between feeding practices and growth and neurodevelopmental outcomes at 36 months of age among children from low- and low-middle-income countries (LMIC).

Methods: We conducted a secondary analysis using data collected from children in India, Pakistan, and Zambia who were enrolled in a randomized controlled trial of a home-based early development intervention program called Brain Research to Ameliorate Impaired Neurodevelopment Home-based Intervention Trial. Qualitative dietary data collected at 36 months was used to assess the modified Minimum Acceptable Diet (mMAD), a measure based on a core indicator developed by the World Health Organization to measure whether young children receive the minimum number of meals recommended and adequate diversity of major food groups in their diet. Regression models were used to assess cross-sectional associations between diet and growth indices, including Z-scores for height-for-age (HAZ), weight-for-age (WAZ), weight-for-height (WHZ), head circumference (HCZ), and Bayley Scales of Infant Development II mental and psychomotor developmental measures at 36 months of age.

Results: Of 371 children, 174 (47%) consumed the mMAD, with significantly higher mean adjusted WHZ than those who did not meet mMAD (0.20 vs - 0.08, = 0.05). Egg consumption was found to be significantly associated with a decreased risk of wasting [adjusted RR (95% CI): 0.37 (0.15, 0.89), = 0.03]. HCZ at 36 months did not differ significantly for children who did and did not receive the mMAD.

Conclusion: Meeting the mMAD was associated with better weight-for-height outcomes at 36 months in children in these three LMIC, highlighting the importance of adequate food quantity and quality.

Trial Registration: registered on March 20, 2008.
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http://dx.doi.org/10.1186/s40795-018-0228-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050755PMC
April 2018

Effect of prophylactic or therapeutic administration of paracetamol on immune response to DTwP-HepB-Hib combination vaccine in Indian infants.

Vaccine 2017 05 24;35(22):2999-3006. Epub 2017 Apr 24.

Shantha Biotechnics Private Limited - A Sanofi Company, Hyderabad, India.

Background: Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever.

Methods: Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups.

Results: Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups.

Conclusion: The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872)].
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http://dx.doi.org/10.1016/j.vaccine.2017.03.009DOI Listing
May 2017

Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants.

Hum Vaccin Immunother 2016 04 18;12(4):946-54. Epub 2015 Nov 18.

l Shantha Biotechnics Private Limited , Hyderabad , India.

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.
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http://dx.doi.org/10.1080/21645515.2015.1100779DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4962968PMC
April 2016

Neonatal mortality and coverage of essential newborn interventions 2010 - 2013: a prospective, population-based study from low-middle income countries.

Reprod Health 2015 8;12 Suppl 2:S6. Epub 2015 Jun 8.

Background: Approximately 3 million neonatal deaths occur each year worldwide. Simple interventions have been tested and found to be effective in reducing the neonatal mortality. In order to effectively implement public health interventions, it is important to know the rates of neonatal mortality and understand the contributing risk factors. Hence, this prospective, population-based, observational study was carried out to inform these needs.

Methods: The Global Network's Maternal Newborn Health Registry was initiated in the seven sites in 2008. Registry administrators (RAs) attempt to identify and enroll all eligible women by 20 weeks gestation and collect basic health data, and outcomes after delivery and at 6 weeks post-partum. All study data were collected, reviewed, and edited by staff at each study site. The study was reviewed and approved by each sites' ethics review committee.

Results: Overall, the 7-day neonatal mortality rate (NMR) was 20.6 per 1000 live births and the 28-day NMR was 25.7 per 1000 live births. Higher neonatal mortality was associated with maternal age > 35 and <20 years relative to women 20-35 years of age. Preterm births were at increased risk of both early and 28-day neonatal mortality (RR 8.1, 95% CI 7.5-8.8 and 7.5, 95% CI 6.9-8.1) compared to term as were those with low birth weight (<2500g). Neonatal resuscitation rates were 4.8% for hospital deliveries compared to 0.9% for home births. In the hospital, 26.5% of deliveries were by cesarean section with an overall cesarean section rate of 12.5%. Neonatal mortality rates were highest in the Pakistan site and lowest in Argentina.

Conclusions: Using prospectively collected data with high follow up rates (99%), we documented characteristics associated with neonatal mortality. Low birth weight and prematurity are among the strongest predictors of neonatal mortality. Other risk factors for neonatal deaths included male gender, multiple gestation and major congenital anomalies. Breech presentation/transverse lie, and no antenatal care were also significant risk factors for neonatal death. Coverage of interventions varied by setting of delivery, with the overall population rate of most evidence-based interventions low. This study informs about risk factors for neonatal mortality which can serve to design strategies/interventions to reduce risk of neonatal mortality.

Trial Registration: The trial is registered at clinicaltrials.gov. ClinicalTrial.gov

Trial Registration: NCT01073475.
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http://dx.doi.org/10.1186/1742-4755-12-S2-S6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4464215PMC
March 2016

Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings.

Reprod Health 2015 8;12 Suppl 2:S2. Epub 2015 Jun 8.

Background: To describe quantitative data quality monitoring and performance metrics adopted by the Global Network's (GN) Maternal Newborn Health Registry (MNHR), a maternal and perinatal population-based registry (MPPBR) based in low and middle income countries (LMICs).

Methods: Ongoing prospective, population-based data on all pregnancy outcomes within defined geographical locations participating in the GN have been collected since 2008. Data quality metrics were defined and are implemented at the cluster, site and the central level to ensure data quality. Quantitative performance metrics are described for data collected between 2010 and 2013.

Results: Delivery outcome rates over 95% illustrate that all sites are successful in following patients from pregnancy through delivery. Examples of specific performance metric reports illustrate how both the metrics and reporting process are used to identify cluster-level and site-level quality issues and illustrate how those metrics track over time. Other summary reports (e.g. the increasing proportion of measured birth weight compared to estimated and missing birth weight) illustrate how a site has improved quality over time.

Conclusion: High quality MPPBRs such as the MNHR provide key information on pregnancy outcomes to local and international health officials where civil registration systems are lacking. The MNHR has measures in place to monitor data collection procedures and improve the quality of data collected. Sites have increasingly achieved acceptable values of performance metrics over time, indicating improvements in data quality, but the quality control program must continue to evolve to optimize the use of the MNHR to assess the impact of community interventions in research protocols in pregnancy and perinatal health.

Trial Registration Number: NCT01073475.
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http://dx.doi.org/10.1186/1742-4755-12-S2-S2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4464020PMC
March 2016

Development of a 12 month screener based on items from the Bayley II Scales of Infant Development for use in Low Middle Income countries.

Early Hum Dev 2015 Apr 2;91(4):253-8. Epub 2015 Mar 2.

Department of Statistics Epidemiology, RTI International, Durham, NC, United States.

Objectives: The purpose of the current study was to adapt the Bayley Scales of Infant Development II for use as a screening measure that could be used by health care professionals in Low Middle Income (LMI) countries with 12 month old infants to determine if they needed further assessment and early intervention.

Methods: The adaptations were made as part of a larger study of children participating in a home-based early intervention program in India, Pakistan, and Zambia. Using Item Response Theory, a brief 12 month screener, with excellent sensitivity and specificity was identified.

Results: The proposed 12 month screener contains 7 mental/cognitive items and 5 motor items. Children who cannot perform more than 3 items on the mental scale (sensitivity 79%, specificity 85%) and/or 3 items on the motor scale (sensitivity 96%, specificity 95%) should be referred for further assessment.

Conclusion: This screener can reliably be used to determine if a child needs further developmental assessment.
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http://dx.doi.org/10.1016/j.earlhumdev.2015.02.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4381992PMC
April 2015

A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial.

Lancet 2015 Feb 15;385(9968):629-639. Epub 2014 Oct 15.

University of Colorado School of Medicine, Denver, CO, USA.

Background: Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries.

Methods: In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096.

Findings: The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47,394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50,743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48,219 women in the intervention group and 867 (2%) of 51,523 in the control group (OR 1·45, 1·33-1·58, p<0·0001).

Interpretation: Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased.

Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development.
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http://dx.doi.org/10.1016/S0140-6736(14)61651-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420619PMC
February 2015

Dose of early intervention treatment during children's first 36 months of life is associated with developmental outcomes: an observational cohort study in three low/low-middle income countries.

BMC Pediatr 2014 Oct 25;14:281. Epub 2014 Oct 25.

Psychological Sciences and Health Sciences Research Institute, University of California, Merced, CA, USA.

Background: The positive effects of early developmental intervention (EDI) on early child development have been reported in numerous controlled trials in a variety of countries. An important aspect to determining the efficacy of EDI is the degree to which dosage is linked to outcomes. However, few studies of EDI have conducted such analyses. This observational cohort study examined the association between treatment dose and children's development when EDI was implemented in three low and low-middle income countries as well as demographic and child health factors associated with treatment dose.

Methods: Infants (78 males, 67 females) born in rural communities in India, Pakistan, and Zambia received a parent-implemented EDI delivered through biweekly home visits by trainers during the first 36 months of life. Outcome was measured at age 36 months with the Mental (MDI) and Psychomotor (PDI) Development Indices of the Bayley Scales of Infant Development-II. Treatment dose was measured by number of home visits completed and parent-reported implementation of assigned developmental stimulation activities between visits. Sociodemographic, prenatal, perinatal, and child health variables were measures as correlates.

Results: Average home visits dose exceeded 91% and mothers engaged the children in activities on average 62.5% of days. Higher home visits dose was significantly associated with higher MDI (mean for dose quintiles 1-2 combined = 97.8, quintiles 3-5 combined = 103.4, p = 0.0017). Higher treatment dose was also generally associated with greater mean PDI, but the relationships were non-linear. Location, sociodemographic, and child health variables were associated with treatment dose.

Conclusions: Receiving a higher dose of EDI during the first 36 months of life is generally associated with better developmental outcomes. The higher benefit appears when receiving ≥91% of biweekly home visits and program activities on ≥67% of days over 3 years. It is important to ensure that EDI is implemented with a sufficiently high dose to achieve desired effect. To this end groups at risk for receiving lower dose can be identified and may require special attention to ensure adequate effect.
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http://dx.doi.org/10.1186/1471-2431-14-281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4288653PMC
October 2014

Unusual cause of esophageal obstruction in a neonate presenting as esophageal atresia.

J Neonatal Surg 2013 Oct-Dec;2(4):47. Epub 2013 Oct 1.

Department of Pediatric Surgery, KLE University, Belgaum, Karnataka, India.

Esophageal atresia is the commonest cause of obstruction to esophageal lumen in neonates. Foreign bodies in newborns are extremely rare. We report a rare case of esophageal obstruction closely mimicking atresia due to foreign bodies inserted in a female neonate with homicidal intension.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420298PMC
May 2015

Surgical management of congenital hyperinsulinism in a resource-limited setting.

J Neonatal Surg 2013 Apr-Jun;2(2):26. Epub 2013 Apr 1.

Department of Pediatric Surgery, Jawaharlal Nehru Medical College Belgaum Karnataka, India.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420376PMC
May 2015

ENC training reduces perinatal mortality in Karnataka, India.

J Matern Fetal Neonatal Med 2012 Jun 27;25(6):568-74. Epub 2011 Jul 27.

Jawaharlal Nehru Medical College, Belgaum, India.

Objective: To evaluate the effect of World Health Organization Essential Newborn Care course and the American Academy of Pediatrics Neonatal Resuscitation Program training on perinatal mortality in rural India.

Methods: This study was part of a multi-country prospective, community-based cluster randomized controlled trial. Birth, 7-day and 28-day neonatal outcomes for all women with pregnancies greater than 28 weeks in the 26 study communities in Karnataka, India were included. Mortality rates pre- and post-Essential Newborn Care training were collected prospectively and then communities randomized to either receive neonatal resuscitation or refresher newborn care training in the control clusters.

Results: Consent was obtained on 99% of the 25,096 births. Perinatal mortality for infants ≥500 g decreased from 52 to 36/1000 after newborn care training (RR 0.7; 95% CI 0.5, 0.9); stillbirth decreased from 23 to 14/1000 (RR 0.62; 95% CI 0.46, 0.83) and early neonatal mortality decreased from 29 to 22/1000 (RR 0.74; 95% CI 0.53, 1.03). Mortality was not reduced further with resuscitation training.

Conclusions: Using a pre-post design, World Health Organization Essential Newborn Care community birth attendant training resulted in a significant reduction in perinatal mortality. In low-resource settings, the newborn care training package appears to be an effective intervention to decrease perinatal mortality.
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http://dx.doi.org/10.3109/14767058.2011.584088DOI Listing
June 2012

Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).

BMC Pediatr 2010 Apr 30;10:27. Epub 2010 Apr 30.

Psychological Sciences and Health Sciences Research Institute, University of California, Merced, 5200 Lake Road, Merced, CA 95343, USA.

Background: This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia.

Methods/design: This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors.

Discussion: The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential to inform about strategies for reducing neurodevelopmental disabilities in at-risk young children in low and middle income countries.
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http://dx.doi.org/10.1186/1471-2431-10-27DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873519PMC
April 2010
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