CURRENT PROJECTS:

1.Phase III, Multi-centric, Randomized, Double-blind, Placebo-controlled, Superiority trial to evaluate efficacy of Probiotic supplementation for prevention of Neonatal sepsis in 0-2 months old Low Birth Weight (LBW) Infants in India – ICMR/MRC ICMR, New Delhi in collaboration with the six study sites/hospitals in India is conducting a randomized, placebo-controlled, double blind trial to evaluate the efficacy of a probiotic blend (Vivomixx Drop) in reducing the incidence of neonatal sepsis in low birth weight (LBW) infants in the 0-2-month period. A total of 6100 LBW neonates will be enrolled, 3050 each in intervention and control arm. As one of the 6 participating sites, we will be conducting a study in Meerut, UP, India in collaboration with Subharti Medical College. In this study LBW babies in the identified hospitals, meeting the eligibility criteria will be enrolled and randomized to receive either probiotic Vivomixx or a similar looking substance (placebo), once daily for 30 days. Follow up visits will be done daily at home during the first week of life, twice a week during second to fourth week of life, and weekly during the second month. During these visits, field worker will screen the infants for morbidity and refer the sick infants to the study hospital for evaluation by the physician. At the facility/hospital, examination for clinical signs, blood samples from sick infants suspected sepsis for diagnosis of neonatal sepsis will be done. Project Location: Meerut, Uttar Pradesh, IN Project Started: Dec 2020 Funded By: Indian Council for Medical Research / Medical Research Council (UK)
2.Global Scale of Early Childhood Development (GSED) While the importance of early development has been well recognized globally, universal measures designed to quantify early child development (ECD) are lacking, particularly for the youngest children. Measurement tools are necessary not only for tracking progress toward meeting global policy goals, but also for informing resource allocation and programming to provide the necessary support to enable children to reach their developmental potential. Current measures of child development range from proxy measures to detailed measures of individual performance that can be expensive, culturally inappropriate, or time-intensive to administer. Neither these proxy measures nor the individual measures are adequate for program evaluation. As yet, there are no widely accepted universal measures of ECD that can be applied at the population level for children under 3 years of age. The overarching aim of the Global Scale for Early Development (GSED) Project is to develop a robust, universal and psychometrically sound scale to measure development of children aged 0-3 years through two measurement instruments. This study aims at the validation of the GSED instruments (short and long form). Project Location: Pemba, Zanzibar, TZ Project Started: June 2020 Funded By: World Health Organization (WHO)
3.MOMI Biorepository Platform: AMANHI Tanzania To identify new insights and biomarkers for preterm birth and other pregnancy complications to inform prediction and treatment and improve maternal and neonatal health. Project Location: Pemba, Zanzibar, TZ Project Started: October 2020 Funded By: The Bill and Melinda Gates Foundation (BMGF)
4.COVID-19: Harnessing AMANHI Infrastructure to Assess Direct Impact on MNCH Ongoing AMANHI pregnancy biorepository cohorts, in which children are being followed up for growth and development until 2-3 years of age, offer a unique opportunity to address crucial gaps in knowledge about how COVID-19 impacts women and children.

The objectives of the study are to

1. Determine the age-specific cumulative incidence of COVID-19 infection, as determined by seroconversion, among 1 to 4 years old children and mothers (women of reproductive age) enrolled in the AMANHI-ACT study.
2. Determine proportion of infections causing moderate or severe COVID-19 disease among women of reproductive age and children under-5 years of age.
3. Investigate epidemiological, biological, serological, socio-economic and nutritional status as possible risk factors for infection, and severity of disease given infection.
4. Evaluate the impact of asymptomatic or symptomatic SARS-CoV-2 infection on the risk of subsequent infection and severity of disease.
5. For pregnant women identified in the cohort:
a) Evaluate the clinical presentation, utilization of preventive care, complications, treatment and clinical course of disease for pregnant women or women who have delivered in the last eight weeks who are infected with COVID-19
b) Evaluate the pregnancy, delivery and newborn outcomes among those born to women who have had COVID-19 and identify subgroups that are at a higher for adverse outcomes.
c) To collect data in a harmonized manner and contribute to pooled analysis with other ongoing pregnancy in COVID-cohorts such as those conducted by WHO/SRH and PRIORITY network.
6. Document the non-COVID-19 related health care utilization for preventive and curative health services for pregnant and non-pregnant women and children and how these are affected by the COVID-19 epidemic.

Project Location: Pemba, Zanzibar, TZ
Project Started: Oct 2020
Funded By: World Health Organization (WHO

UPCOMING PROJECTS

1.The NutriMAM Trial – Options for the nutritional management of moderate wasting in children in the context of acute infection The NUTRI-MAM trial will aim to evaluate the efficacy of locally available foods (LAF) or microbiota directed supplementary food (MDSF) compared to RUSF, when given to moderately wasted children presenting to health facilities with an acute illness, on initial anthropometric recovery (within 12 weeks of enrolment) and sustained recovery (at 24 weeks after enrolment). Project Location: Meerut, Uttar Pradesh, IN Project Duration: 3 Years Funded By: World Health Organization (WHO)
2.The Growth Trial – Nutritional management of growth faltering in LBW/SGA/PTB infants Optimal early nutrition improves the immediate survival prospects of the most at-risk newborns as well as the trajectory of their physical and cognitive development. Despite the importance of nutrition, there is a weak evidence base on how to effectively support the nutritional demands of newborns born too early or born too small, young infants who fail to grow adequately and experience growth faltering, and infants less than 6 months of age with acute malnutrition, particularly in resource constrained settings. Globally, approximately 15% of babies are born LBW, with a significantly higher burden in South Asia where one in four babies are LBW. This early vulnerability increases their risk of subsequent growth failure and early incidence of acute malnutrition within the first 6 months of life. Data from 18 LMIC longitudinal cohorts (supported by the foundation’s KI “wasting rally”), demonstrates that early growth faltering and subsequent wasting begins by 2-3 months of age, much earlier than initially thought, at a time when children are expected to be exclusively breasted. By 6 months of age, 18% of infants had experienced at least one wasting episode since birth, with increased risk among LBW/SGA/PTB babies. This Project will focus on early infant nutrition and provide evidence for the following priorities:  

1. How to improve screening and identification of infants less than 6 months of age with growth failure;

2. How to improve management of infants less than 6 months of age with growth failure;
3. How to prevent growth failure among infants less than 6 months of age in low resource settings.
Project Location: Pemba, Zanzibar, TZ
Project Duration: 3 Years
Funded By: World Health Organization (WHO)

PREVIOUS PROJECTS:

1.Antibiotics for Children with Severe Diarrhoea (ABCD) Trial Antibiotics for Children with Diarrhoea (ABCD) trial was meant to determine the efficacy of two antibiotics (azithromycin and ciprofloxacin), compared to placebo, in reducing risk of death and linear growth faltering in the three months and 6 months following an episode of diarrhoea among children (2-23 months of age) at high-risk of diarrhoea-associated mortality. In this double-blind, placebo controlled, randomized trial, 11,500 children aged 2 to 23 months presenting to hospitals in 7 Asian and African countries with acute diarrhoea and either malnutrition and or dehydration had been enrolled and randomized to receive a three-day course of azithromycin or placebo. Children were re-assessed at day-90 and then at day -180 to determine the vital status of the child and to obtain anthropometric measurements. A sub-set of children was also enrolled in the AMR sub-study and followed at day 90 and day 180 for additional stool and nasal swab collection. Project Location: Meerut, Uttar Pradesh, IN Project Duration: June 2016 – July 2020 Funded By: World Health Organization (WHO)
2.MOMI – Multi Omics for Mothers and Infants (Pemba Tanzania) The goals included lowering both infant and maternal morbidity/mortality in low resource settings through innovation and implementation. This project was meant to directly address the critical issues by identifying new predictive biomarkers for preterm birth, preeclampsia, stillbirth and IUGR (intrauterine growth restriction) to enable treatment and triage to decrease the disease burden. In addition it was to identify new biological mechanisms underpinning the causes of preterm birth, preeclampsia, stillbirth and IUGR to create a platform to generate new approaches to treatment and prevention. The Alliance for Maternal and Newborn Health Improvement (AMANHI) study in Pemba has been established to best characterize population based longitudinal cohort of pregnant women and their babies in sub–Saharan Africa. Our goal was to establish and maintain a bio-bank in resource limited setting in East Africa; develop local capacity around bio-banking and the use of biological samples to explore future hypotheses as new methods and technologies become available to advance knowledge on key adverse pregnancy outcomes including preterm births, miscarriages, still births, IUGR and SGA. Population-based bio-banks will help translate -omics discoveries into promising diagnostic, treatment and prevention strategies that can be further tested in intervention trials. The integration of genome-based knowledge into epidemiological and public health research, policies and health services seems to be the most important public health challenge. Having a characterized cohort of pregnancy with all the metadata presents a unique opportunity to investigate clinical, biochemical markers and add these data to the database having metadata, omics data and outcomes of pregnancy both as associations and etiological path analysis. Project Location: Pemba, Zanzibar, TZ Project Duration: Nov 2018 – Oct 2020 Funded By: The Bill and Melinda Gates Foundation (BMGF)
3.All Children Thrive (ACT) Study: Epigenetic and biological markers of preterm births, fetal growth, early childhood growth and neurodevelopment expanding the scope of AMANHI pregnancy Bio-repository cohort. Following a pregnancy cohort to determine the burden, timing and causes of maternal deaths and stillbirths. Additional information was collected on the same women as in to determine the burden of major maternal morbidity, care received, and the association of morbidity and care with stillbirths, prematurity, intrauterine growth restriction and neonatal mortality to identify a programmatically feasible method for accurate assessment of gestational age. Additionally a bio-repository was created to test hypothesized biological markers as predictors of important maternal and fetal outcomes. The AMANHI Biobank cohort was further extended to 4500 women, to find epigenetic and biological markers of linear growth and neurodevelopment in the first 3 years of life using biological samples from the mother and the infant collected during pregnancy, at the time of birth and at the end of the postnatal period, and accompanying information on maternal, newborn and family characteristics. Project Location: Pemba, Zanzibar, TZ Project Duration: June 2016 – Dec 2020 Funded By: World Health Organization (WHO)
4.Establishing the optimal dose of therapeutic zinc supplementation for the treatment of acute diarrhoea in under five children – a dose response trial in a South Asian and a Sub-Saharan African setting. ZTDT STUDY The Zinc Trial Dosing Therapy (ZTDT) study was a double-blind randomized controlled trial of three doses of zinc (20mg/day, 10mg/day and 5mg/day) that was undertaken in India and Tanzania with the overall aim to identify the optimal dose of zinc in children with acute diarrhoea under the age 5 years with diarrhoea, evaluating safety of the low dose as compared to standard dose in risk of vomiting within 30 minutes. Other objectives were to evaluate if lower doses of zinc have any impact on post- acute illness morbidity, acceptability of the low dose zinc supplement and whether there is any association between different doses of zinc on plasma zinc levels at days 3,7,15, 21 and 30. Project Location: New Delhi/Meerut, Uttar Pradesh, IN Duration: Started: June 2016 to Dec 2019 Funded By: World Health Organization (WHO)
5.Healthy Birth, Growth and Development Knowledge Integration (HBGDki) Initiative Access to Clinical Trial Data of the study entitled ‘Randomized double blind, controlled trial with a 2-by-2 factorial design to assess the effects of zinc or vitamin and mineral (calcium, phosphorous, folate, and iron) supplementations on development, growth, morbidity, and mortality in 1- to 9-month old SGA infants’ for the Healthy Birth, Growth and Development Knowledge Integration (HBDGk1) Initiative. The limited dataset under Agreement Letter for Data Set Alignment (ALDSA) was shared which included dataset, code book, Data Definition file, study related documents (protocol, data collection forms, CRF and published papers) Project Location: New Delhi, IN Duration: Mar 2017 – Mar 2018 Funded By: BIRAC (Biotechnology Industry Research Assistance Council)
6.Prospective observational study of Rotavirus Infection in infants in Sangam Vihar, New Delhi, India to prepare for a proposed Rotavirus Vaccine efficacy trial. Project Brief: In a prospective, observational study 200 infants in two cohorts in two age intervals (6-8 weeks or 8-12 months) were enrolled and followed weekly for 6 months to evaluate the occurrence of diarrhea. This was an observational study intended to mimic all operational aspects required to successfully implement a large rotavirus Phase III vaccine efficacy trial at multiple sites in India. Project Location: New Delhi, IN Duration: 2011 To 2012 Funded By: PATH (Program for Appropriate Technology in Health), USA & Serum Institute of India Limited, India
7.Efficacy of High Zinc-Biofortified Wheat Consumption in Improvement of Micronutrient Status, and Prevention of Morbidity among Preschool Children (aged 4-6 years) and Women of Child Bearing Age- A Double Masked, Randomized, Controlled Trial. This study aimed to evaluate the efficacy of Zinc bio fortified wheat flour on zinc status and its impact on morbidity; physical growth; and compliance to wheat flour among children aged 4-6 years and non-pregnant non lactating woman of child bearing age (WCBA) in Delhi, India. In a community based, double-masked randomized controlled trial, 6005 participants (WCBA and child pair) were enrolled in Sangam Vihar (a resettlement colony in outskirts of South Delhi) and Harsh Vihar (semi-urban locality in North East District of Delhi) and randomly allocated to receive either high Zinc bio fortified wheat flour (HZn, 30 ppm Zinc daily) or low Zinc bio fortified wheat flour (LZn, 20 ppm zinc daily) for 6 months (WCBA@360 g/day and children @120g/day).Weekly household surveillance was conducted to gather information on compliance and morbidity. During the follow up, dietary data was collected on a sub-sample using an interactive 24-hour dietary recall method and FFQ. The clinical examination, anthropometric measurements and blood sampling assessments were repeated at end-study (after 6 months of follow-up) to estimate changes in zinc/iron status indicators, growth parameters and prevention of morbidity. Project Location: New Delhi, IN Duration: 2013 To 2016 Funded By: HARVEST PLUS [Centro Internacional de Agricultura Tropical (CIAT) and International Food Policy Research Institute (IFPRI) (Via Johns Hopkins University)]