Dataset Information

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial.

ABSTRACT: Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrollment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.

SUBMITTER: NEOVITA Study Author Group

PROVIDER: S-EPMC3337818 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial.

Bahl Rajiv R Bhandari Nita N Dube Brinda B Edmond Karen K Fawzi Wafaie W Fontaine Olivier O Kaur Jasmine J Kirkwood Betty R BR Martines Jose J Masanja Honorati H Mazumder Sarmila S Msham Salum S Newton Sam S Oleary Maureen M Ruben Julia J Shannon Caitlin C Smith Emily E Taneja Sunita S Yoshida Sachiyo S

Trials 20120223

<h4>Background</h4>Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplem ...[more]

PMID: 22361251

Similar Datasets

Project description:BackgroundVitamin A deficiency (VAD) impairs T-cell-mediated immunity. In regions where VAD is prevalent, vitamin A supplementation (VAS) reduces child mortality, perhaps by improving immune function.ObjectiveOur objective was to determine if neonatal VAS would improve thymic function in Bangladeshi infants, and to determine if such effects differed by sex or nutritional status (i.e., birth weight above/below the median).MethodsThree hundred and six infants were randomly assigned to 50,000 IU vitamin A (VA) or placebo (PL) within 48 h of birth. Primary outcomes were measured at multiple ages and included 1) thymic index (TI) at 1, 6, 10, and 15 wk; 2) T-cell receptor excision circles (TREC), an index of thymic output of naïve T cells; and 3) total/naïve T cells in peripheral blood at 6 wk, 15 wk, and 2 y. A mixed linear model for repeated measures was used to assess group differences at each age and identify interactions with sex and birth weight.ResultsVAS did not significantly (P = 0.21) affect TI overall (i.e., at all ages) but decreased TI by 7.8% (P = 0.029) at 6 wk: adjusted TI means for the PL and VA groups at 1, 6, 10, and 15 wk were 4.09 compared with 3.80 cm2, 7.78 compared with 7.18 cm2, 8.11 compared with 7.84 cm2, and 7.91 compared with 7.97 cm2, respectively. VAS did not significantly (P = 0.25) affect TREC overall but decreased TREC by 19% (P = 0.029) at 15 wk: adjusted TREC means for the PL and VA groups at 6 wk, 15 wk, and 2 y were 13.6 compared with 16.1 copies/pg DNA, 19.4 compared with 15.7 copies/pg DNA, and 11.8 compared with 10.0 copies/pg DNA, respectively. VAS did not significantly affect overall total (P = 0.10) or naïve (P = 0.092) T cells: adjusted naïve T-cell means for the PL and VA groups at 6 wk, 15 wk, and 2 y were 3259 compared with 3109 cells/µL, 3771 compared with 3487 cells/µL, and 1976 compared with 1898 cells/µL, respectively.ConclusionIn contrast to our hypothesis, VAS decreased thymic function early in infancy but health effects are presumably negligible owing to the transience and small magnitude of this effect. This trial was registered at clinicaltrials.gov as NCT01583972 and NCT02027610.

Project description:BackgroundSupplementation of vitamin A in children aged 6-59 months improves child survival and is implemented as global policy. Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results. We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days (6 months).MethodsWe did an individually randomised, double-blind, placebo-controlled trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania. Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dar es Salaam. In Kilombero, Ulanga, and Kilosa districts, women were seen at home as part of the health and demographic surveillance system. Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months. We randomly assigned infants to receive one dose of 50,000 IU of vitamin A or placebo in the first 3 days after birth. Infants were randomly assigned in blocks of 20, and investigators, participants' families, and data analysis teams were masked to treatment assignment. We assessed infants on day 1 and day 3 after dosing, as well as at 1, 3, 6, and 12 months after birth. The primary endpoint was mortality at 6 months, assessed by field interviews. The primary analysis included only children who were not lost to follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12610000636055.FindingsBetween Aug 26, 2010, and March 3, 2013, 31,999 newborn babies were randomly assigned to receive vitamin A (n=15,995) or placebo (n=16,004; 15,428 and 15,464 included in analysis of mortality at 6 months, respectively). We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months (26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group; risk ratio 1·10, 95% CI 0·95-1·26; p=0·193). There was no evidence of a differential effect for vitamin A supplementation on mortality by sex; risk ratio for mortality at 6 months for boys was 1·08 (0·90-1·29) and for girls was 1·12 (0·91-1·39). There was also no evidence of adverse effects of supplementation within 3 days of dosing.InterpretationNeonatal vitamin A supplementation did not result in any immediate adverse events, but had no beneficial effect on survival in infants in Tanzania. These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation.FundingBill & Melinda Gates Foundation to WHO.

Project description:BACKGROUND: Neonatal mortality currently accounts for 41% of all global deaths among children below five years. Despite recording a 33% decline in neonatal deaths between 2000 and 2009, about 900,000 neonates died in India in 2009. The decline in neonatal mortality is slower than in the post-neonatal period, and neonatal mortality rates have increased as a proportion of under-five mortality rates. Neonatal mortality rates are higher among rural dwellers of India, who make up at least two-thirds of India's population. Identifying the factors influencing neonatal mortality will significantly improve child survival outcomes in India. METHODS: Our analysis is based on household data from the nationally representative 2008 Indian District Level Household Survey (DLHS-3). We use probit regression techniques to analyse the links between neonatal mortality at the household level and households' access to health facilities. The probability of the child dying in the first month of birth is our dependent variable. RESULTS: We found that 80% of neonatal deaths occurred within the first week of birth, and that the probability of neonatal mortality is significantly lower when the child's village is closer to the district hospital (DH), suggesting the critical importance of specialist hospital care in the prevention of newborn deaths. Neonatal deaths were lower in regions where emergency obstetric care was available at the District Hospitals. We also found that parental schooling and household wealth status improved neonatal survival outcomes. CONCLUSIONS: Addressing the main causes of neonatal deaths in India--preterm deliveries, asphyxia, and sepsis--requires adequacy of specialised workforce and facilities for delivery and neonatal intensive care and easy access by mothers and neonates. The slow decline in neonatal death rates reflects a limited attention to factors which contribute to neonatal deaths. The suboptimal quality and coverage of Emergency Obstetric Care facilities in India require urgent attention.

Project description:BackgroundInfancy is a crucial period for establishing the intestinal microbiome. This process may be influenced by vitamin A (VA) status because VA affects intestinal immunity and epithelial integrity, factors that can, in turn, modulate microbiome development.ObjectivesThe aim of this study was to determine if neonatal VA supplementation (VAS) affected the abundance of Bifidobacterium, a beneficial commensal, or of Proteobacteria, a phylum containing enteric pathogens, in early (6-15 wk) or late (2 y) infancy. Secondary objectives were to determine if VAS affected the abundance of other bacterial taxa, and to determine if VA status assessed by measuring plasma retinol was associated with bacterial abundance.MethodsThree hundred and six Bangladeshi infants were randomized by sex and birthweight status (above/below median) to receive 1 VA dose (50,000 IU) or placebo within 48 h of birth. Relative abundance at the genus level and above was assessed by 16S rRNA gene sequencing. A terminal restriction fragment-length polymorphism assay was used to identify Bifidobacterium species and subspecies at 6 wk.ResultsLinear regression showed that Bifidobacterium abundance in early infancy was lower in boys (median, 1st/3rd quartiles; 0.67, 0.52/0.78) than girls (0.73, 0.60/0.80; P = 0.003) but that boys receiving VAS (0.69, 0.55/0.78) had higher abundance than boys receiving placebo (0.65, 0.44/0.77; P = 0.039). However this difference was not seen in girls (VAS 0.71, 0.54/0.80; placebo 0.75, 0.63/0.81; P = 0.25). VAS did not affect Proteobacteria abundance. Sex-specific associations were also seen for VA status, including positive associations of plasma retinol with Actinobacteria (the phylum containing Bifidobacterium) and Akkermansia, another commensal with possible health benefits, for girls in late infancy.ConclusionsBetter VA status in infancy may influence health both in infancy and later in life by promoting the establishment of a healthy microbiota. This postulated effect of VA may differ between boys and girls. This trial was registered at clinicaltrials.gov as NCT02027610.

Project description:BackgroundGhana did not meet the Millennium Development Goal 4 of reducing child mortality by two-thirds and may not meet SDG (2030). There is a need to direct scarce resources to mitigate the impact of the most important risk factors influencing high neonatal deaths. This study applied both spatial and non-spatial regression models to explore the differential impact of environmental, maternal, and child associated risk factors on neonatal deaths in Ghana.MethodsThe study relied on data from the Ghana Demographic and Health Surveys (GDHS) and the Ghana Maternal Health Survey (GMHS) conducted between 1998 and 2017 among 49,908 women of reproductive age and 31,367 children under five (GDHS-1998 = 3298, GDHS-2003 = 3844, GDHS-2008 = 2992, GDHS-2014 = 5884, GMHS-2017 = 15,349). Spatial Autoregressive Models that account for spatial autocorrelation in the data at the cluster-level and non-spatial statistical models with appropriate sampling weight adjustment were used to study factors associated with neonatal deaths, and a p-value less than 0.05 was considered statistically significant.ResultsPopulation density, multiple births, smaller household sizes, high parity, and low birth weight significantly increased the risk of neonatal deaths over the years. Among mothers who had multiple births, the risk of having neonatal deaths was approximately four times as high as the risk of neonatal deaths among mothers who had only single birth [aRR = 3.42, 95% CI: 1.63-7.17, p < 0.05]. Neonates who were perceived by their mothers to be small were at a higher risk of neonatal death compared to very large neonates [aRR = 2.08, 95% CI: 1.19-3.63, p < 0.05]. A unit increase in the number of children born to a woman of reproductive age was associated with a 49% increased risk in neonatal deaths [aRR = 1.49, 95% CI: 1.30-1.69, p < 0.05].ConclusionNeonatal mortality in Ghana remains relatively high, and the factors that predisposed children to neonatal death were birth size that were perceived to be small, low birth weight, higher parity, and multiple births. Improving pregnant women's nutritional patterns and providing special support to women who have multiple deliveries will reduce neonatal mortality in Ghana.

Project description:BackgroundCause-specific mortality data are required to set interventions to reduce neonatal mortality. However, in many developing countries, these data are either lacking or of low quality. We assessed the completeness and accuracy of cause of death (COD) data for neonates in Ghana to assess their usability for monitoring the effectiveness of health system interventions aimed at improving neonatal survival.MethodsA lot quality assurance sampling survey was conducted in 20 hospitals in the public sector across four regions of Ghana. Institutional neonatal deaths (IND) occurring from 2014 through 2017 were divided into lots, defined as neonatal deaths occurring in a selected facility in a calendar year. A total of 52 eligible lots were selected: 10 from Ashanti region, and 14 each from Brong Ahafo, Eastern and Volta region. Nine lots were from 2014, 11 from 2015 and 16 each were from 2016 and 2017. The cause of death (COD) of 20 IND per lot were abstracted from admission and discharge (A&D) registers and validated against the COD recorded in death certificates, clinician's notes or neonatal death audit reports for consistency. With the error threshold set at 5%, ≥ 17 correctly matched diagnoses in a sample of 20 deaths would make the lot accurate for COD diagnosis. Completeness of COD data was measured by calculating the proportion of IND that had death certificates completed.ResultsNineteen out of 52 eligible (36.5%) lots had accurate COD diagnoses recorded in their A&D registers. The regional distribution of lots with accurate COD data is as follows: Ashanti (4, 21.2%), Brong Ahafo (7, 36.8%), Eastern (4, 21.1%) and Volta (4, 21.1%). Majority (9, 47.4%) of lots with accurate data were from 2016, followed by 2015 and 2017 with four (21.1%) lots. Two (10.5%) lots had accurate COD data in 2014. Only 22% (239/1040) of sampled IND had completed death certificates.ConclusionDeath certificates were not reliably completed for IND in a sample of health facilities in Ghana from 2014 through 2017. The accuracy of cause-specific mortality data recorded in A&D registers was also below the desired target. Thus, recorded IND data in public sector health facilities in Ghana are not valid enough for decision-making or planning. Periodic data quality assessments can determine the magnitude of the data quality concerns and guide site-specific improvements in mortality data management.

Dataset Information

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial.

Publications

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets