Shally Awasthi

Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial

BACKGROUND In rural India, most births take place in the home, where high-risk care practices are common. We developed an intervention of behaviour change management, with a focus on prevention of hypothermia, aimed at modifying practices and reducing neonatal mortality. METHODS We did a cluster-randomised controlled efficacy trial in Shivgarh, a rural area in Uttar Pradesh. 39 village administrative units (population 104,123) were allocated to one of three groups: a control group, which received the usual services of governmental and non-governmental organisations in the area; an intervention group, which received a preventive package of interventions for essential newborn care (birth preparedness, clean delivery and cord care, thermal care [including skin-to-skin care], breastfeeding promotion, and danger sign recognition); or another intervention group, which received the package of essential newborn care plus use of a liquid crystal hypothermia indicator (ThermoSpot). In the intervention clusters, community health workers delivered the packages via collective meetings and two antenatal and two postnatal household visitations. Outcome measures included changes in newborn-care practices and neonatal mortality rate compared with the control group. Analysis was by intention to treat. This study is registered as International Standard Randomised Control Trial, number NCT00198653. FINDINGS Improvements in birth preparedness, hygienic delivery, thermal care (including skin-to-skin care), umbilical cord care, skin care, and breastfeeding were seen in intervention arms. There was little change in care-seeking. Compared with controls, neonatal mortality rate was reduced by 54% in the essential newborn-care intervention (rate ratio 0.46 [95% CI 0.35-0.60], p<0.0001) and by 52% in the essential newborn care plus ThermoSpot arm (0.48 [95% CI 0.35-0.66], p<0.0001). INTERPRETATION A socioculturally contextualised, community-based intervention, targeted at high-risk newborn-care practices, can lead to substantial behavioural modification and reduction in neonatal mortality. This approach can be applied to behaviour change along the continuum of care, harmonise vertical interventions, and build community capacity for sustained development. FUNDING USAID and Save the Children-US through a grant from the Bill & Melinda Gates Foundation.

Causes of neonatal and child mortality in India: a nationally representative mortality survey.

BACKGROUND More than 2·3 million children died in India in 2005; however, the major causes of death have not been measured in the country. We investigated the causes of neonatal and child mortality in India and their differences by sex and region. METHODS The Registrar General of India surveyed all deaths occurring in 2001-03 in 1·1 million nationally representative homes. Field staff interviewed household members and completed standard questions about events that preceded the death. Two of 130 physicians then independently assigned a cause to each death. Cause-specific mortality rates for 2005 were calculated nationally and for the six regions by combining the recorded proportions for each cause in the neonatal deaths and deaths at ages 1-59 months in the study with population and death totals from the United Nations. FINDINGS There were 10,892 deaths in neonates and 12,260 in children aged 1-59 months in the study. When these details were projected nationally, three causes accounted for 78% (0·79 million of 1·01 million) of all neonatal deaths: prematurity and low birthweight (0·33 million, 99% CI 0·31 million to 0·35 million), neonatal infections (0·27 million, 0·25 million to 0·29 million), and birth asphyxia and birth trauma (0·19 million, 0·18 million to 0·21 million). Two causes accounted for 50% (0·67 million of 1·34 million) of all deaths at 1-59 months: pneumonia (0·37 million, 0·35 million to 0·39 million) and diarrhoeal diseases (0·30 million, 0·28 million to 0·32 million). In children aged 1-59 months, girls in central India had a five-times higher mortality rate (per 1000 livebirths) from pneumonia (20·9, 19·4-22·6) than did boys in south India (4·1, 3·0-5·6) and four-times higher mortality rate from diarrhoeal disease (17·7, 16·2-19·3) than did boys in west India (4·1, 3·0-5·5). INTERPRETATION Five avoidable causes accounted for nearly 1·5 million child deaths in India in 2005, with substantial differences between regions and sexes. Expanded neonatal and intrapartum care, case management of diarrhoea and pneumonia, and addition of new vaccines to immunisation programmes could substantially reduce child deaths in India. FUNDING US National Institutes of Health, International Development Research Centre, Canadian Institutes of Health Research, Li Ka Shing Knowledge Institute, and US Fund for UNICEF.

Effects of treatment for intestinal helminth infection on growth and cognitive performance in children: systematic review of randomised trials

Abstract Objective: To summarise the effects of anthelmintic drug treatment on growth and cognitive performance in children. Data sources: Electronic databases: Cochrane Infectious Diseases Group controlled trial register, Cochrane controlled trials register, Embase, and Medline. Citations of all identified trials. Contact with the World Health Organization and field researchers. Review methods: Systematic review of randomised controlled trials in children aged 1–16 that compared anthelmintic treatment with placebo or no treatment. Assessment of validity and data abstraction conducted independently by two reviewers. Main outcome measures: Growth and cognitive performance. Results: Thirty randomised controlled trials in more than 15 000 children were identified. Effects on mean weight were unremarkable, and heterogeneity was evident in the results. There were some positive effects on mean weight change in the trials reporting this outcome: after a single dose (any anthelmintic) the pooled estimates were 0.24 kg (95% confidence interval 0.15 kg to 0.32 kg; fixed effects model assumed) and 0.38 kg (0.01 kg to 0.77 kg; random effects model assumed). Results from trials of multiple doses showed mean weight change in up to one year of follow up of 0.10 kg (0.04 kg to 0.17 kg; fixed effects) or 0.15 kg (0.00 to 0.30; random effects). At more than one year of follow up, mean weight change was 0.12 kg (−0.02 kg to 0.26 kg; fixed effects) and 0.43 (−0.61 to 1.47; random effects). Results from studies of cognitive performance were inconclusive. Conclusions: There is some limited evidence that routine treatment of children in areas where helminths are common has effects on weight gain, but this is not consistent between trials. There is insufficient evidence as to whether this intervention improves cognitive performance.

Three day versus five day treatment with amoxicillin for non-severe pneumonia in young children: a multicentre randomised controlled trial.

Abstract Objective To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children. Design Randomised, double blind, placebo controlled multicentre trial. Setting Outpatient departments of seven referral hospitals in India. Participants 2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days. Intervention Oral amoxicillin 31-54 mg/kg/day in three divided doses. Main outcome measures Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90% on day 3. Results The clinical cure rates with three days and five days of treatment were 89.5% and 89.9%, respectively (absolute difference 0.4 (95% confidence interval - 2.1 to 3.0)). Adherence to treatment regimen was 94% and 85% for three day and five day treatments, respectively. Loss to follow up was 5.4% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3%) clinical failures and 106 (5.3%) relapses, and rates were similar in both treatments. At enrolment, 513 (23.4%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4%) and 496 (22.8%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)). Conclusions Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia.

Burden of infectious diseases in South Asia

Infectious diseases are a major cause of death in South Asia, with children incurring a disproportionate share of the burden. This review discusses the underlying causes of some of the more common diseases and strategies to improve their detection and control Preventable infections are a major cause of deaths and disabilities in South Asia. Over two thirds of the estimated 3.7 million deaths in children in South Asia in the year 2000 were attributable to infections such as pneumonia, diarrhoea, and measles.1 2 India now has the second largest population with AIDS and HIV infection in the world, and tuberculosis and chronic hepatitis continue to threaten the lives of millions. Of the overall burden of deaths related to infectious disease in the region, around 63% are in children aged under 5 years.3 Serious effort should be devoted to the control of infectious disease if South Asian countries are to meet their millennium development goal of two thirds reduction in child mortality by 2015. Sri Lanka alone among South Asian countries has made remarkable progress in reducing the burden of infectious disease, despite civil war and meagre resources. This review describes the burden of infectious diseases of public health importance in South Asia, the underlying risk factors, and strategies to improve detection and control. We searched PubMed and the databases of the World Health Organization and Unicef for information on infectious diseases of public health importance in South Asia. We also reviewed the bibliographies of key references and reviews for relevant information. People in South Asia are at a higher risk of developing infectious diseases and dying from their illness than people in industrialised countries.3 The root causes are poverty and its associated problems of unhygienic living conditions, malnutrition, illiteracy, and poor access to clean water, toilet facilities, …

Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

Summary Background In north India, vitamin A deficiency (retinol <0·70 μmol/L) is common in pre-school children and 2–3% die at ages 1·0–6·0 years. We aimed to assess whether periodic vitamin A supplementation could reduce this mortality. Methods Participants in this cluster-randomised trial were pre-school children in the defined catchment areas of 8338 state-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks (clusters) were cluster-randomly allocated in Oxford, UK, between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the childs mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of retinol effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial vitamin A to sample blood (for retinol assay, technically reliable only after mid-study), examine eyes, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at ages 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly retinol supplements was 86%. Among 2581 versus 2584 children surveyed during the second half of the study, mean plasma retinol was one-sixth higher (0·72 [SE 0·01] vs 0·62 [0·01] μmol/L, increase 0·10 [SE 0·01] μmol/L) and the prevalence of severe deficiency was halved (retinol <0·35 μmol/L 6% vs 13%, decrease 7% [SE 1%]), as was that of Bitots spots (1·4% vs 3·5%, decrease 2·1% [SE 0·7%]). Comparing the 36 retinol-allocated versus 36 control blocks in analyses of the primary outcome, deaths per child-care centre at ages 1·0–6·0 years during the 5-year study were 3·01 retinol versus 3·15 control (absolute reduction 0·14 [SE 0·11], mortality ratio 0·96, 95% CI 0·89–1·03, p=0·22), suggesting absolute risks of death between ages 1·0 and 6·0 years of approximately 2·5% retinol versus 2·6% control. No specific cause of death was significantly affected. Interpretation DEVTA contradicts the expectation from other trials that vitamin A supplementation would reduce child mortality by 20–30%, but cannot rule out some more modest effect. Meta-analysis of DEVTA plus eight previous randomised trials of supplementation (in various different populations) yielded a weighted average mortality reduction of 11% (95% CI 5–16, p=0·00015), reliably contradicting the hypothesis of no effect. Funding UK Medical Research Council, USAID, World Bank (vitamin A donated by Roche).

Polymorphisms of TNF-enhancer and gene for FcγRIIa correlate with the severity of falciparum malaria in the ethnically diverse Indian population

BackgroundSusceptibility/resistance to Plasmodium falciparum malaria has been correlated with polymorphisms in more than 30 human genes with most association analyses having been carried out on patients from Africa and south-east Asia. The aim of this study was to examine the possible contribution of genetic variants in the TNF and FCGR2A genes in determining severity/resistance to P. falciparum malaria in Indian subjects.MethodsAllelic frequency distribution in populations across India was first determined by typing genetic variants of the TNF enhancer and the FCGR2A G/A SNP in 1871 individuals from 55 populations. Genotyping was carried out by DNA sequencing, single base extension (SNaPshot), and DNA mass array (Sequenom). Plasma TNF was determined by ELISA. Comparison of datasets was carried out by Kruskal-Wallis and Mann-Whitney tests. Haplotypes and LD plots were generated by PHASE and Haploview, respectively. Odds ratio (OR) for risk assessment was calculated using EpiInfo™ version 3.4.ResultsA novel single nucleotide polymorphism (SNP) at position -76 was identified in the TNF enhancer along with other reported variants. Five TNF enhancer SNPs and the FCGR2A R131H (G/A) SNP were analyzed for association with severity of P. falciparum malaria in a malaria-endemic and a non-endemic region of India in a case-control study with ethnically-matched controls enrolled from both regions. TNF -1031C and -863A alleles as well as homozygotes for the TNF enhancer haplotype CACGG (-1031T>C, -863C>A, -857C>T, -308G>A, -238G>A) correlated with enhanced plasma TNF levels in both patients and controls. Significantly higher TNF levels were observed in patients with severe malaria. Minor alleles of -1031 and -863 SNPs were associated with increased susceptibility to severe malaria. The high-affinity IgG2 binding FcγRIIa AA (131H) genotype was significantly associated with protection from disease manifestation, with stronger association observed in the malaria non-endemic region. These results represent the first genetic analysis of the two immune regulatory molecules in the context of P. falciparum severity/resistance in the Indian population.ConclusionAssociation of specific TNF and FCGR2A SNPs with cytokine levels and disease severity/resistance was indicated in patients from areas with differential disease endemicity. The data emphasizes the need for addressing the contribution of human genetic factors in malaria in the context of disease epidemiology and population genetic substructure within India.

Gender inequity and age-appropriate immunization coverage in India from 1992 to 2006

BackgroundA variety of studies have considered the affects of Indias son preference on gender differences in child mortality, sex ratio at birth, and access to health services. Less research has focused on the affects of son preference on gender inequities in immunization coverage and how this may have varied with time, and across regions and with sibling compositions. We present a systematic examination of trends in immunization coverage in India, with a focus on inequities in coverage by gender, birth order, year of birth, and state.MethodsWe analyzed data from three consecutive rounds of the Indian National Family Health Survey undertaken between 1992 and 2006. All children below five years of age with complete immunization histories were included in the analysis. Age-appropriate immunization coverage was determined for the following antigens: bacille Calmette-Guérin (BCG), oral polio (OPV), diphtheria, pertussis (whooping cough) and tetanus (DPT), and measles.ResultsImmunization coverage in India has increased since the early 1990s, but complete, age-appropriate coverage is still under 50% nationally. Girls were found to have significantly lower immunization coverage (p<0.001) than boys for BCG, DPT, and measles across all three surveys. By contrast, improved coverage of OPV suggests a narrowing of the gender differences in recent years. Girls with a surviving older sister were less likely to be immunized compared to boys, and a large proportion of all children were found to be immunized considerably later than recommended.ConclusionsGender inequities in immunization coverage are prevalent in India. The low immunization coverage, the late immunization trends and the gender differences in coverage identified in our study suggest that risks of child mortality, especially for girls at higher birth orders, need to be addressed both socially and programmatically.Abstract in HindiSee the full article online for a translation of this abstract in Hindi.

A study on determinants of immunization coverage among 12 -- 23 months old children in urban slums of Lucknow district India.

CONTEXT To find out the suitable factors for raising the coverage of immunization. AIMS To determine the coverage and to identify the various factors of primary immunization. SETTINGS AND DESIGN Urban slums of Lucknow district. METHODS AND MATERIAL WHO 30-cluster sampling technique was used for the selection of the subjects. Mother, father or relative of a total of 510 children with 17 children per cluster were interviewed in the study. STATISTICAL ANALYSIS Chi-square test, binary logistic regression and multinomial logistic regression analysis were done to test the statistical significance of the association. RESULTS About 44% of the children studied were fully immunized. Multinomial logistic regression analysis revealed that an illiterate mother (OR=4.0), Muslim religion (OR=2.5), scheduled caste or tribes (OR=2.3) and higher birth order (OR approximately 2) were significant independent predictors of the partial immunized status of the child; while those associated with the unimmunized status of the child were low socioeconomic status (OR=10.8), Muslim religion (OR=4.3), higher birth order (OR=4.3), home delivery (OR=3.6) and belonging to a joint family (OR=2.1). CONCLUSIONS The status of complete immunization is about half of what was proposed to be achieved under the Universal Immunization Program. This emphasizes the imperative need for urgent intervention to address the issues of both dropout and lack of access, which are mainly responsible for partial immunization and nonimmunization respectively.

Neonatal, 1–59 month, and under-5 mortality in 597 Indian districts, 2001 to 2012: estimates from national demographic and mortality surveys

BACKGROUND India has the largest number of child deaths of any country in the world, and has wide local variation in under-5 mortality. Worldwide achievement of the UN 2015 Millennium Development Goal for under-5 mortality (MDG 4) will depend on progress in the subregions of India. We aimed to estimate neonatal, 1-59 months, and overall under-5 mortality by sex for 597 Indian districts and to assess whether India is on track to achieve MDG 4. METHODS We divided the 2012 UN sex-specific birth and mortality totals for India into state totals using relative birth rates and mortality from recent demographic surveys of 24 million people, and divided state totals into totals for the 597 districts using 3 million birth histories. We then split the results into neonatal mortality and 1-59 month mortality using data for 109,000 deaths in children younger than 5 years from six national surveys. We compared results with the 2001 census for each district. FINDINGS Under-5 mortality fell at a mean rate of 3·7% (IQR 3·2-4·9) per year between 2001 and 2012. 222 (37%) of 597 districts are on track to achieve the MDG 4 of 38 deaths in children younger than 5 years per 1000 livebirths by 2015, but an equal number (222 [37%]) will achieve MDG 4 only after 2020. These 222 lagging districts are home to 41% of Indias livebirths and 56% of all deaths in children younger than 5 years. More districts lag behind the relevant goal for neonatal mortality (251 [42%]) than for 1-59 month mortality (197 [33%]). Just 81 (14%) districts account for 37% of deaths in children younger than 5 years nationally. Female mortality at ages 1-59 months exceeded male mortality by 25% in 303 districts in nearly all states of India, totalling about 74,000 excess deaths in girls. INTERPRETATION At current rates of progress, MDG 4 will be met by India around 2020-by the richer states around 2015 and by the poorer states around 2023. Accelerated progress to reduce mortality during the neonatal period and at ages 1-59 months is needed in most Indian districts. FUNDING Disease Control Priorities 3, Canadian Institutes of Health Research, International Development Research Centre, US National Institutes of Health.