Health and Nutrition
Research is dedicated to understand the determinants of impaired growth and development in children, the cross talk between nutrition and infection and reasons for slow progress in reducing rates of stunting in India. SAS has developed and evaluated multiple interventions to elucidate their clinical, biological and biochemical effects in the continuum from pre-conception, different phases of pregnancy and childhood. The drivers of impairment are common as well as unique at different time points in the continuum.
Research is dedicated to elucidate determinants of survival and morbidity, with major emphasis on development of interventions for reducing child mortality and promoting growth and development.
Vitamin A and Mucosal Infections
Our research showed that vitamin A deficiency decreases severe diarrhea but not pneumonia. Vitamin A supplementation reduced prevalence of diarrhea associated with fever by 36% (BMJ 1994;309:1404-7). It revealed that the effect of optimizing vitamin A intakes on mucosal infections is restricted to the gut, indicating a unique mechanism distinct from that of zinc.
Lack of Benefit of Vitamin A Supplementation in Early Infancy
Our research confirmed the safety of the intervention but showed no sustained benefits in terms of vitamin A status beyond 6 months or infant morbidity (Lancet 1998;352:1257-63). The study promptly halted a global decision by the UNICEF to extend the vitamin A program to under 6 months old children rather than keep it restricted to children older than 9 months, therefore, having a major influence on policy.
Impact of Food Supplementation and Encouragement to Feed on Weight Gain in Infants Aged 4 to 12 Months
We conducted a randomized, controlled trial to determine the growth impact of provision of a precooked complementary food appropriate in quality given daily from 4 to 12 mo of age with encouragement to use in optimal amounts versus nutritional counseling alone. Food supplementation and encouragement to feed resulted in substantial increase in weight gain between 6 and 9 mo of age with little additional increment in the 16- to 26-wk and 38- to 52-wk periods. Nutritional counseling resulted in smaller but significant increases in dietary intake without affecting breastfeeding or morbidity (J Nutr 2001; 131(7):1946-51)
Role of Zinc Supplementation in Prevention of Pneumonia and Diarrhea
Designed and implemented the largest study of zinc supplementation in children of low income communities to examine its impact on pneumonia and diarrhea. The study established that optimal zinc intake can prevent up to 26% of pneumonia in young children (Br Med J 2002; 324:1358-1362) and reduce the incidence of diarrhea by 12%, severe diarrhea by 24% and recurrent diarrhea by 49% (Pediatrics 2002;109 (6):86-92). This triggered global interest in zinc deficiency as a problem, similar in magnitude to iron and vitamin A deficiency.
Use of Zinc-fortified ORS for Treatment of Acute Diarrhea
The study established the efficacy of zinc as a treatment of acute diarrhea, using zinc fortified oral rehydration solutions (J Pediatr 2002;141:677-682). The use of zinc as a treatment for diarrhea achieved WHO endorsement.
Promotion of Exclusive Breastfeeding for 6 Months and Educational Interventions for Improved Complementary Feeding Practices
Demonstrated favourable impact of exclusive breast feeding for 6 months on severe morbidity and growth. This had an impact on the nationwide programmes for exclusive breastfeeding up to 6 months (Lancet 2003;361:1418-1423).
Zinc and Low Osmolarity ORS
Established effectiveness of zinc and low osmolarity ORS in the community for treatment of diarrhea and as a disease prevention measure. This study resulted in policy impact in India and developing countries (J Pediatr Gastroenterol Nutr 2005; 41:685-687, Pediatrics 2008; 121:e1279-85, Bull World Health Organ 2010; 88:717-796
WHO Growth Standards for Children
Our group was the Asian site for the development of the WHO growth standards. We demonstrated that growth of Indian infants can reach global standards. WHO launched the new child growth standards in Year 2006 that are being used across the world for assessment of child growth (Bull World Health Organ 2002; 80:189-195, Food Nutr Bull 2004; 25:S66-71, Acta Paediatrica 2006; 95 (supplement 450).
Zinc Deficiency and Infections, Linear Growth and Mortality
Demonstrated zinc deficiency as a public health problem and that zinc supplementation reduces the incidence and severity of enteric and respiratory infections (Acta Paediatr 1996;85:148-50, Am J Clin Nutr 1998; 68:414S-7S), mortality (J Nutr 2007; 137:112-117), linear growth (J Nutr 2010;140:630-634) and low birth weight infants (Am J Clin Nutr 2009;90:385-91). Paved way for global and national efforts to combat zinc deficiency.
Impact of Integrated Management of Neonatal and Childhood Illness (IMNCI) on Infant Mortality and Morbidity
Through a complex cluster randomized effectiveness trial demonstrated that IMNCI delivered through primary care system reduces infant mortality (overall) and severe morbidity (BMJ 2012;344:e1634, BMJ 2014;349:g4988). IMNCI is a part of the national program with increased focus on newborn and infant care. Integrating neonatal and child health at community and health facility level is feasible on a large scale for implementation by the district health system
Impact of Neonatal Vitamin A Supplementation
We demonstrated lack of substantial benefit of large dose neonatal vitamin A supplementation in neonates given at birth in reduction of infant mortality in a population in which vitamin A deficiency is a moderate public health outcome. Evidence contributed to halting efforts to encourage neonatal vitamin A supplementation in Asian settings (Trials 2012;13:22 Lancet 2014; pii: S0140-6736(14)60891-6).
Impact of Vitamin B12 and Folic Acid Supplementation on Growth, Common Infections and Hemoglobin in Children
Our research demonstrated that that poor vitamin B-12 status contributes to poor growth (Pediatrics 2015;135:e918-26). However, neither folic acid nor vitamin B-12 supplementation reduced the incidence of diarrhea or lower respiratory infections (Am J Clin Nutr 2013;98:731-7). The trial also provided evidence that supplementation of folic acid and/or vitamin B12 for 6 months does not improve Hb concentration in young children (Clin Nutr. 2016 pii: S0261-5614(16)30168-6).
Home-based Management of Severe Acute Malnutrition
The first randomised trial comparing RUTF with energy and nutrient-dense home-prepared foods (the comparison group) confirms the efficacy of RUTF in the treatment of children with uncomplicated SAM. The study provided insights on the importance of feeding efforts and the caregiver support required for higher efficacy and highlights the importance of adequate continued inputs after initial treatment to sustain the benefits. Recommendations for policy: Children with uncomplicated SAM can be managed at home with RUTF instead of through inpatient hospitalisation (BMJ Global Health 2016; DOI:10.1136/bmjgh-2016-000144).
In a secondary analysis of data from the trial, we assessed the performance of Mid Upper Arm Circumference (MUAC) as a predictor of mortality in children aged 6–59 months, one year after their initial MUAC measurements were taken. The finding revealed that MUAC is a significant predictor of subsequent mortality in under-five children. MUAC can be used as a screening tool for identifying severely malnourished children for management in settings where height measurement is not feasible (PLoS One. 2018;13(6):e0197832).
Strengthening Management of Pneumonia and Neonatal Sepsis
Conducted a cluster-randomized trial to assess the benefits of an Enhanced Integrated Community Case Management (ICCM) Approach for treatment of pneumonia in under-five children compared to ICCM. The findings revealed that CHWs can effectively and safely treat fast breathing pneumonia and chest-indrawing pneumonia with oral amoxicillin without referral [Acta Paediatrica 2018; 107(Suppl):80-88; Int J Clin Trials 2020;7:131-141; Int J Clin Trials 2020; 7:83-93].
Impact of Kangaroo Mother Care (KMC) on Neonatal Mortality and Morbidity
Conducted formative research to assess the feasibility, acceptability and adoption of community-initiated KMC with the aim of designing an intervention package for a randomised controlled trial in LBW infants in Haryana, India, which demonstrated that community-initiated KMC is acceptable by mothers and adoption rates are high (BMC Public Health 2018;18:307)
Conducted the first and the largest community-initiated randomized controlled trial demonstrating irrefutable evidence of the benefits of community initiated KMC on reducing neonatal mortality, pneumonia, diarrhea and severe acute malnutrition, and increased exclusive breastfeeding in low birth weight infants (Trials 2017;18:262; Lancet. 2019;394:1724-1736).
Kangaroo Mother Care Implementation Research to Develop Models for Accelerating Scale-up
Conducted implementation research to scale up high and effective KMC coverage in facilities and communities in rural and semi-urban areas of an entire district of Haryana The scale up model developed for 1 district was implemented across additional 16 districts in Haryana, 3 facilities in Himachal Pradesh, Hamdard Institute of Medical Sciences and Research, (Dr. MK Bhan Memorial Kangaroo Mother Unit), New Delhi) and sub-district hospital in Pune, Maharashtra (BMJ Open. 2019;9:e025879).
Management of Possible Serious Bacterial Infections in Young Infants Closer to Home Where Referral is not Feasible
We conducted an implementation research in Sangrah, a remote hilly block of Himachal Pradesh, to encourage the health functionaries to use the simplified treatment regimen, with the aim to achieve 80% identification and treatment of infants aged 0-59 days with PSBI, and documentation of key barriers and facilitators that influence the use of the simplified treatment regimen. About 80% (160) of the expected PSBI cases were identified, of them 48 (30%) sick infants accepted referral to a tertiary care hospital and 112 (70%) were treated according to the simplified treatment regimen at SC, PHC and CHC. Treatment failure rate was 8% in the group receiving simplified treatment regimen and 10% in those treated in a tertiary care hospital, which is comparable. There were 2 deaths (CFR 1.2%) in the former group and 4 (CFR 8.3%) in the latter. Timely identification of signs of illness by families and health system weaknesses such as non-availability of essential commodities, medicines and human resource gaps were challenges in implementation of the guideline. Implementation of the guidelines in program settings is possible and acceptable. Scaling up would require creating community awareness, early identification and appropriate care seeking, strengthening ASHA home visitation program, building skills and confidence of MOs and ANMs, uninterrupted supplies and a dependable referral system (PLoS One 2020;15:e0243724) .
Maternal Malnutrition and Lactation Performance with Breastfeeding Infants: Observational Study in Haryana
Exclusive breastfeeding from birth to 6 months is one of the most cost effective child survival interventions available today but little is known currently about what causes growth failure or how to prevent it in the exclusively breastfed children. There remain gaps in understanding of mechanisms through which maternal nutrition impacts growth failure.
We examined the association between maternal nutrition indicators and lactation performance in a cross sectional sample of 232 women in Haryana. This innovative research will fill critical knowledge gaps and inform the design of future interventions to reduce growth faltering in first 6 months of life.
Impact of Nutritional Interventions Among Lactating Mothers on Growth of their Infants in the First 6 Months of Life
In lower-middle income settings, growth faltering in the first 6 months of life occurs despite exclusive breastfeeding. We tested the efficacy of an approach to improve the dietary adequacy of mothers during lactation and thus improve the growth of their infants. Eligible mother–infant dyads (infants ≤7 days of age) were randomized to either intervention or control groups. Mothers in the intervention group received snacks that were to be consumed daily, which provided 600 kcal of energy—with 25–30% of energy derived from fats (150-180 kcal) and 13% of energy from protein (80 kcal). Micronutrients were supplemented as daily tablets. We provided counseling on breastfeeding and infant-care practices to mothers in both groups. The primary outcome was attained infant length-for-age z-scores (LAZ) at 6 months of age. Secondary outcomes included exclusive breastfeeding proportion reported by the mother, maternal body mass index (BMI) and mid-upper arm circumference (MUAC), hemoglobin concentrations in mothers and infants, and the proportion of anemic infants at 6 months of age. Postnatal supplementation of 600 kcal energy, 20 g protein, and multiple micronutrients daily to lactating mothers did not affect infant LAZ at age 6 months. Trial Registration CTRI/2018/04/013095
Nutritional Interventions to Improve Linear Growth during Infancy in India: 6-12 Months Old Infants (IMPRINT Trial)
Around 40% of under-five children in India are stunted and they do not reach their full developmental potential. Much of this stunting occurs in the first two years. We do not currently have effective strategies for promoting linear growth in the first year of life in resource constrained populations in LMICs. The trial aims to address this critical gap in knowledge that hinders development of effective strategies. The knowledge that will be generated from this study is both of high scientific and public health importance. It will answer the scientific question on the benefits of increasing protein quantity and quality in complementary foods to improve linear growth in the second 6 months of life in a population with high rates of stunting. We are evaluating two nutritional supplements in 6-12 month old infants, compared to a control group that will receive counselling but no food supplementation. The first intervention group is given a supplement that provides ~125 Kcal of non-breast milk energy requirement, 2.5 g protein (30% or 0.75 g from animal source foods), 30-45% of energy from fats (i.e. 37.5 to 56.3 Kcal from 4.2 to 6.3 g of fats), and micronutrients. The second intervention group receives 125 Kcal of non-breast milk energy requirement, 5.6 g protein (30% i.e. 1.68 g from animal source foods), 30-45% of energy from fats (i.e. 37.5 to 56.3 Kcal from 4.2 to 6.3 g), and micronutrients. The two supplement groups will be compared with the control group and with each other for their effect on linear growth and to provide a dose response for the intervention effect. This will help governments and implementing agencies design better nutrition programmes for infants, which in turn would reduce childhood stunting rates in LMICs (Trial Registration CTRI/2018/04/012932)
Women and Infants Integrated Growth Study (WINGS)
Adverse birth outcomes such as prematurity, intrauterine growth retardation, stunting and cognitive impairment in young children are driven by risk factors in women of reproductive age prior to and during pregnancy.
The study aims to assess the impact of a package of health, nutrition, psychosocial care and environmental interventions delivered in pre pregnancy, pregnancy and first 2 years of the child’s life on birth weight and length, prematurity, fetal growth restriction and stunting at 2 years age (Trials. 2020;21(1):127).
This study will help in understanding the extent to which linear growth can be accelerated when all evidence-based interventions are delivered with high compliance. It will indicate the importance of providing interventions during the pre- and peri-conception periods for reducing prematurity and stunting. It will also address whether maternal height is an effect modifier in the intervention impact. Status: Study ongoing (Trial Registration CTRI/2017/06/008908)
KMC in Hospital Setting with Mask on Care of the Small Babies (Including Kangaroo Mother Care) in the Covid 19 Pandemic: A Multicountry Survey and Qualitative Analysis
In pursuit of SDG 3 targets, countries are trying to scale up life saving interventions for LBW, KMC is one of them. COVID has created a dilemma regarding KMC practice that involves dose contact between mother and baby, among health care providers amidst recommendations for social distancing.
There are no specific guidelines on KMC in low birth weight babies during COVID.
The purpose of this rapid survey is to understand how KMC and newborn care practices have changed during COVID and to come up with possible solutions that can help guide policies and practice.
This is a part of a WHO initiative with researchers who had previously been part of multicountry KMC and low birth weight research studies led by WHO.
Study on Reproductive Tract Infections/Sexually Transmitted Infections (RTI/STI) among Urban and Peri-urban Women in North India
There are very limited data on RTI/STIs in India. There is uncertainty regarding the etiologic magnitude of the RTI/STI problem. Apart from few prevalence surveys among key populations, there are no population-based RTI/STI data.
This is an observational study to determine the prevalence of laboratory confirmed RTI/STIs (Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Candida albicans and bacterial vaginosis among symptomatic and asymptomatic women of reproductive age group
Evidence generated through this study will provide important information for the national RTI/STI case management guidelines. Status: Study Ongoing (Trial Registration: CTRI/2020/03/023954).
Postpartum Contraceptive Practices among Urban and Peri-urban Women in North India
Unmet need of family planning is highest among women in the postpartum period, so ensuring women have access to high quality postpartum family planning services, in both urban and rural areas, is an important strategy to improve maternal and childhood health outcomes.
This is an observational study to describe the modern and traditional contraceptive practices during the postpartum period.
The data generated will provide useful insights into couples’ preference and choice of contraception, initiation time and the effect of birth spacing on subsequent linear growth of the child. Status: Study ongoing (Trial Registration: CTRI/2020/03/023967).
Experiences and Actions Taken by Women to Address Failure to Conceive in an Urban Setting in India
Limited research is available on how women cope with infertility and the actions taken. Also, understanding household out-of-pocket expenditure in the quest to conceive is important in formulating the kind of subsidies that can be provided in the context of fertility care services.
This is an observational study to describe women’s actions and experiences related to failure to conceive, their quality of life and mental health (anxiety and depression) and costs related to interventions to enhance fertility.
The findings will provide essential information for developing additional supportive environment, policies and services for infertile couples in India. Status: Study ongoing (Trial Registration: CTRI/2020/03/023955)
Effect of COVID19 Pandemic and Lockdown on Utilization of Essential Health Services, Quality of Life and Psychosocial Impact in Urban and Peri-urban low- to mid-socioeconomic Neighborhoods in South Delhi
The COVID pandemic has disrupted the essential services for sexual, reproductive, maternal, newborn and child health care in low and middle income countries.
In this study our aim is to estimate the disruption in essential services due to COVID and lockdown by comparing proportion of women and infants who accessed and availed these services before, during and after the lockdown period, the barriers to utilization of services, psychosocial impact and any stigma associated with COVID.
The results will provide useful insights for guidance and preparation for similar situation in future and possible mitigation strategies. Status: Completed (Trial Registration: CTRI/2020/07/026389).
Possible Serious Bacterial Infections (PSBI) Formative Research
A randomized controlled trial will be done to address the question on whether OPD based treatment of young infants with low mortality risk clinical severe infection signs, results in better outcome compared to hospital based treatment.
Due to the COVID pandemic, situations have changed with possible impact on the management of PSBI at the study sites.
The formative research, prior to study initiation aims to identify the barriers and facilitators for PSBI management in young infants throughout the entire pathway from identification to care seeking, receiving treatment and follow up care and formulate acceptable solutions in collaboration with the local government health care providers and caregivers of young infants. The solutions will aim to promote optimal management of sick young infants without jeopardizing with their safety. Status: Completed (Trial Registration CTRI/2020/11/029377).
A Study to Assess the Availability and Readiness of Antenatal, Intrapartum and Postnatal Care Services – A Prospective Longitudinal Study on Maternal and Newborn Health of the Pregnancy Risk Stratification Innovation and Measurement Alliance
Coverage, content and quality of antenatal care is inconsistent and fails to detect risks in a timely manner to enable women to prepare for the birth, especially among vulnerable populations (lower wealth quintiles, rural area). There is lack of robust population level burden data to inform global and local estimation of key risk factors, vulnerabilities and morbidity and mortality outcomes. The aim of this multicountry trial is to develop a robust database to inform machine learning for the purpose of pregnancy risk stratification.
Pregnancy surveillance and health systems assessment (HSA) will be done to examine the availability and readiness of facilities to provide antenatal care, intrapartum care, and postnatal care with the aim is to strengthen the health systems and optimize maternal, newborn and child care services.
We are a part of a multi country study -A prospective, longitudinal study of maternal and newborn health and Health Systems Assessment to assess availability and readiness of antenatal, intrapartum and postnatal care services. Data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns. Status: Study ongoing.
Implementation Research to Promote Treatment of Pneumonia in Under-five Children in a North Indian District to Achieve High Population-based Coverage
This implementation research aims to achieve high population based coverage of pneumonia treatment for under five children, as recommended in the government of India Guidelines.
Based on the positive previous experiences of using implementation research in scaling up KMC across the state, the trials on operationalizing. Integrated Community Case Management (ICCM) of childhood illnesses by CHWs and the cluster randomized controlled trial to ascertain effectiveness of enhanced community case management to increase access to pneumonia treatment (EMPIC), the government is keen to implement this program to scale up pneumonia treatment. EMPIC interventions include treatment of fast breathing pneumonia in 7-59 days old infants and chest indrawing pneumonia in 2-59 months old children with oral amoxicillin. Treatment will be provided through OPDs, at all government health facilities including HWC, PHC, CHC, DH as well as private OPDs in formal and informal sectors.
OPD based treatment will be provided by trained health staff at the health facilities – Medical Officers, Community Health Officers (CHO), ANMs, MPW.
Status: to be initiated after approvals.
Effect of Daily Supplementation with Multiple Micronutrients and Iron Folic Acid (IFA) Compared to IFA Alone in Children Aged 6 to 59 Months on Anaemia Prevalence and Haemoglobin Concentration
Anemia is a major unresolved public health problem in India, despite a national control programme and routine supplementation with IFA. It has serious consequences on physical and mental development in children. Multiple micronutrient deficiencies are also common in India. It is a priority to understand their contribution on prevalence of anemia.
This study compares the therapeutic efficacy of daily supplementation of erythropoiesis-relevant micronutrients plus iron folic acid, with daily iron folic acid alone in children with mild to moderate anaemia, on proportion cured 3 months post-treatment.
The findings will generate critical information for the current anemia control policy in India and low- and middle-income countries. Status: Study ongoing (CTRI/2020/10/028299).
Effect of Biweekly Preventive Supplementation with Multiple Micronutrients and IFA Compared to IFA Alone in Children Aged 6 to 59 Months on Haemoglobin Concentration and Anaemia Prevalence
Anemia is a major unresolved public health problem in India, despite a national control programme and routine supplementation with IFA. It has serious consequences on physical and mental development in children. The optimal gain in haemoglobin levels and consequently anaemia reduction through iron supplementation may not be achieved in the background of micronutrient deficiency.
This study aims to compare the efficacy of biweekly supplementation of erythropoiesis-relevant multiple micronutrients plus iron folic acid, with daily iron folic acid alone on haemoglobin concentration and proportion anaemic.
The findings will generate critical information for the current anemia control policy in India and low- and middle-income countries. Status: Study ongoing (CTRI/2020/10/028298).
Impact of an Integrated Intervention Package during Preconception, Pregnancy and Early Childhood on Biomarkers of Infant Growth in First 6 Months of Life
Incident stunting and wasting are now identified to be of concern even in the first 6 months of life when exclusive breastfeeding is recommended. Preliminary data from an ongoing intervention study in Delhi within which the current research will be embedded shows that 30-35% of babies experience inadequate weight gain and 20-25% inadequate length gain between 4-6 months of age. Conceptually, this could be related to infant size and gestation at birth, infant enteric or other infections, systemic inflammation, gut microbiome structure, IGF-1, or breast milk composition. The primary research question is to assess an integrated intervention package delivered in 1000 days plus period on breast milk quality, systemic inflammation markers, gut microbiome, and IGF-1 at 6 months of age compared to routine care. In addition, whether the effect of integrated intervention package on growth failure during 4-6 months of age mediates through these biomarkers, will also be assessed. The study will be embedded in an ongoing individual randomized controlled study with factorial design (WINGS) (CTRI/2017/06/008908). 400 mother-infant pairs will be selected (by an independent statistician from WHO) at birth for the study. Biological samples will be collected at 3 and 6 months of life from mother-infant pairs. Status: Study ongoing (Trial Registration CTRI/2020/10/028770)