Accelerated scale-up of Kangaroo Mother Care: Evidence and experience from an implementation-research initiative in south India.

AIM: Though Kangaroo Mother Care (KMC) has demonstrated benefits for low birth weight newborns, coverage continues to be low in India. As part of a World Health Organization (WHO) multi-country study, we explored intervention models to accelerate KMC coverage in a high priority district of Karnataka, India. METHODS: We used implementation-research methods, formative assessments and quality improvement approaches to design and scale-up interventions. Evaluation was done using prospective cohort study design; data were collected from facility records, and client interviews during KMC initiation, at discharge and at home after discharge. RESULTS: KMC was initiated at health facilities for 87.6% of LBW babies under 2000 g. At discharge, 85.0% received KMC; 67.9% continued to receive KMC at home on the 7th day post-discharge. The interventions included training, mentoring and constant advocacy at many levels: public health facilities, private sector and the community. Innovations like a KMC case sheet, counselling, peer support group triggered KMC in the facilities; a KMC-link card, a microplanning and communication tool for CHWs helped to sustain practice at homes. CONCLUSION: The study provides a novel approach to designing and scaling up interventions and suggests lessons that are applicable to KMC as well as to broader reproductive, maternal, neonatal and child health programmes.

Government-led initiative increased the effective use of Kangaroo Mother Care in a region of North India.

AIM: To learn how to achieve high-quality, effective coverage of Kangaroo Mother Care (KMC), defined as 8 hours or more of skin-to-skin contact per day and exclusive breastfeeding in district Sonipat in North India, and to develop and evaluate an implementation model. METHODS: We conducted implementation research using a mixed-methods approach, including formative research, followed by repeated, rapid cycles of implementation, evaluation and refinement until a model with the potential for high and effective coverage was reached. Evaluation of this model was conducted over a 12-month period. RESULTS: Formative research findings informed the final implementation model. Programme learning was critical to achieve high coverage. The model included improving the identification of small babies, creating KMC wards, modification in hospitalisation criteria, private sector engagement and in-built programme learning to refine implementation progress. KMC was initiated in 87% of eligible babies. At discharge, 85% received skin-to-skin contact care, 60% effective KMC and 80% were exclusively breastfed. At home, 7-day post discharge, 81% received skin-to-skin care and 79% were exclusively breastfed in the previous 24 hours. CONCLUSION: Achieving high KMC coverage is feasible in the study setting using a model responsive to the local context and led by the Government.

Early child stimulation, linear growth and neurodevelopment in low birth weight infants.

BACKGROUND: Children with low birth weight (LBW) are at risk of linear growth faltering and developmental deficits. Evidence suggests that early child stimulation and care reflected as responsive caregiving and opportunities for learning can promote development. The current analysis aimed to measure the extent to which linear growth and early child stimulation modify each other's association with neurodevelopmental outcomes among LBW infants. METHODS: This is a secondary data analyses from a randomized controlled trial on the effect of community-initiated kangaroo mother care in LBW infants on their neurodevelopment at 12 months of corrected age. Bayley Scales of Infant and Toddler Development was used to assess cognitive, motor and language scores. Stimulation at home was assessed by the Pediatric Review of Children's Environmental Support and Stimulation (PROCESS) tool. PROCESS scores were categorized into three groups: < Mean-1SD (low stimulation); Mean ± 1 SD (moderate stimulation) and > mean + 1SD (high stimulation). RESULTS: A total of 516 infants were available for neurodevelopment assessments. Interactions were observed between length for age z-score (LAZ) and PROCESS score categories. In the low stimulation group, the adjusted regression coefficients for the association between LAZ and cognitive, motor and language scores were substantially higher than in the moderate and high stimulation group. Stimulation was positively associated with neurodevelopmental outcomes in both stunted and non-stunted infants; however, the association was twice as strong in stunted than in non-stunted. CONCLUSION: Moderate to high quality stimulation may alleviate the risk of sub-optimal development in LBW infants with linear growth deficits. CLINICAL TRIAL REGISTRATION: The primary trial whose data are analysed is registered at clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02631343 ).

Health equity impact of community-initiated kangaroo mother care: a randomized controlled trial.

BACKGROUND: Kangaroo mother care (KMC) can substantially enhance overall survival of low birthweight babies. In a large randomized controlled trial, we recently showed that supporting mothers to provide community initiated KMC (ciKMC) can reduce mortality among infants up to 180 days of life by 25% (hazard ratio (HR) 0.75). With the current analysis, we aimed to explore if ciKMC promotion leads to increased inequity in survival. METHODS: In the trial we randomized 8402 low birthweight babies to a ciKMC (4480 babies) and a control (3922 babies) arm, between 2015 and 2018 in Haryana, India. We estimated the difference in concentration indices, which measure inequality, between babies in the ciKMC and control arms for survival until 180 days of life. Further, we compared the effect of ciKMC promotion across subgroups defined by socioeconomic status, caste, maternal literacy, infant's sex, and religion. RESULTS: Our intervention did not increase survival inequity, as the concentration index in the ciKMC arm of the trial was 0.05 (95% CI -0.07 to 0.17) lower than in the control arm. Survival impact was higher among those belonging to the lower two wealth quintiles, those born to illiterate mothers and those belonging to religions other than Hindu. CONCLUSIONS: We found that ciKMC promotion did not increase inequity in survival associated with wealth. The beneficial impact of ciKMC tended to be larger among vulnerable groups. Supporting mothers to provide KMC at home to low birthweight babies will not increase and could indeed reduce inequities in infant survival. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02653534 . Registered January 12, 2016-Retrospectively registered.

Predictors of recovery in children aged 6-59 months with uncomplicated severe acute malnutrition: a multicentre study.

OBJECTIVE: To identify predictors of recovery in children with uncomplicated severe acute malnutrition (SAM). DESIGN: This is a secondary data analysis from an individual randomised controlled trial, where children with uncomplicated SAM were randomised to three feeding regimens, namely ready-to-use therapeutic food (RUTF) sourced from Compact India, locally prepared RUTF or augmented home-prepared foods, under two age strata (6-17 months and 18-59 months) for 16 weeks or until recovery. Three sets of predictors that could influence recovery, namely child, family and nutritional predictors, were analysed. SETTING: Rural and urban slum areas of three states of India, namely Rajasthan, Delhi and Tamil Nadu. PARTICIPANTS: In total, 906 children (age: 6-59 months) were analysed to estimate the adjusted hazard ratio (AHR) using the Cox proportional hazard ratio model to identify various predictors. RESULTS: Being a female child (AHR: 1·269 (1·016, 1·584)), better employment status of the child's father (AHR: 1·53 (1·197, 1·95)) and residence in a rental house (AHR: 1·485 (1·137, 1·94)) increased the chances of recovery. No hospitalisation (AHR: 1·778 (1·055, 2·997)), no fever, (AHR: 2·748 (2·161, 3·494)) and ≤ 2 episodes of diarrhoea (AHR: 1·579 (1·035, 2·412)) during the treatment phase; availability of community-based peer support to mothers for feeding (AHR: 1·61 (1·237, 2·097)) and a better weight-for-height Z-score (WHZ) at enrolment (AHR: 1·811 (1·297, 2·529)) predicted higher chances of recovery from SAM. CONCLUSION: The probability of recovery increases in children with better WHZ and with the initiation of treatment for acute illnesses to avoid hospitalisation, availability of peer support and better employment status of the father.

Diagnostic measures for severe acute malnutrition in Indian infants under 6 months of age: a secondary data analysis.

BACKGROUND: Weight for length z-score (WLZ) < - 3 is currently used to define severe acute malnutrition (SAM) among infants. However, this approach has important limitations for infants younger than 6 months of age as WLZ cannot be calculated using WHO growth standards if infant length is < 45 cm. Moreover, length for age z-score (LAZ) and weight for length z-score (WLZ) are least reliable measures, with high chances of variation, and less chances of detecting undernutrition in under 6 months infants. The objective of the current analysis was to compare WLZ with WAZ and LAZ in a cohort of Indian infants in predicting the deaths between 6 weeks and 6 months of age. METHODS: The data was from an individually randomized trial conducted in slums of Delhi, India in which infants' weight and length were measured at 6 weeks of age (at the time of the first immunization visit). Vital status of the infants was documented from 6 weeks to 6 months of age. The sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios were calculated for WAZ < -3, WLZ < -3, and LAZ < -3 for deaths between 6 weeks and 6 months of age. The receiver operating characteristics curve was calculated for each of the above anthropometric indicators. RESULTS: For deaths occurring between 6 weeks to 6 months of age, the specificity ranged between 85.9-95.9% for all three anthropometric indicators. However, the sensitivity was considerably higher for WAZ; it was 64.6% for WAZ < -3, 39.1% for LAZ < -3, and 25.0% for WLZ < -3. WAZ < -3 had higher area under curve (0.75; 95% CI: 0.68, 0.82) and hence, better discriminated deaths between 6 weeks and 6 months of age than WLZ < -3. The adjusted relative risk (RR 10.6, 95% CI 5.9, 18.9) and the population attributable fraction (PAF 57.9, 95% CI 38.8, 71.0%) of mortality was highest for WAZ < -3. CONCLUSIONS: We found WAZ < -3 at 6 weeks of age to be a better predictor of death in the 6 weeks to 6 months of life in comparison to WLZ < -3 and LAZ < -3 and propose that it should be considered to diagnose SAM in this age group.

Effect of community-initiated kangaroo mother care on survival of infants with low birthweight: a randomised controlled trial.

BACKGROUND: Coverage of kangaroo mother care remains very low despite WHO recommendations for its use for babies with low birthweight in health facilities for over a decade. Initiating kangaroo mother care at the community level is a promising strategy to increase coverage. However, knowledge of the efficacy of community-initiated kangaroo mother care is still lacking. We aimed to assess the effect of community-initiated kangaroo mother care provided to babies weighing 1500-2250 g on neonatal and infant survival. METHODS: In this randomised controlled, superiority trial, undertaken in Haryana, India, we enrolled babies weighing 1500-2250 g at home within 72 h of birth, if not already initiated in kangaroo mother care, irrespective of place of birth (ie, home or health facility) and who were stable and feeding. The first eligible infants in households were randomly assigned (1:1) to the intervention (community-initiated kangaroo mother care) or control group by block randomisation using permuted blocks of variable size. Twins were allocated to the same group. For second eligible infants in the same household as an enrolled infant, if the first infant was assigned to the intervention group the second infant was also assigned to this group, whereas if the first infant was assigned to the control group the second infant was randomly assigned (1:1) to the intervention or control group. Mothers and infants in the intervention group were visited at home (days 1-3, 5, 7, 10, 14, 21, and 28) to support kangaroo mother care (ie, skin-to-skin contact and exclusive breastfeeding). The control group received routine care. The two primary outcomes were mortality between enrolment and 28 days and between enrolment and 180 days. Analysis was by intention to treat and adjusted for clustering within households. The effect of the intervention on mortality was assessed with person-time in the denominator using Cox proportional hazards model. This study is registered with ClinicalTrials.gov, NCT02653534 and NCT02631343, and is now closed to new participants. FINDINGS: Between July 30, 2015, and Oct 31, 2018, 8402 babies were enrolled, of whom 4480 were assigned to the intervention group and 3922 to the control group. Most births (6837 [81·4%]) occurred at a health facility, 36·2% (n=3045) had initiated breastfeeding within 1 h of birth, and infants were enrolled at an average of about 30 h (SD 17) of age. Vital status was known for 4470 infants in the intervention group and 3914 in the control group at age 28 days, and for 3653 in the intervention group and 3331 in the control group at age 180 days. Between enrolment and 28 days, 73 infants died in 4423 periods of 28 days in the intervention group and 90 deaths in 3859 periods of 28 days in the control group (hazard ratio [HR] 0·70, 95% CI 0·51-0·96; p=0·027). Between enrolment and 180 days, 158 infants died in 3965 periods of 180 days in the intervention group and 184 infants died in 3514 periods of 180 days in the control group (HR 0·75, 0·60-0·93; p=0·010). The risk ratios for death were almost the same as the HRs (28-day mortality 0·71, 95% CI 0·52- 0·97; p=0·032; 180-day mortality 0·76, 0·60-0·95; p=0·017). INTERPRETATION: Community-initiated kangaroo mother care substantially improves newborn baby and infant survival. In low-income and middle-income countries, incorporation of kangaroo mother care for all infants with low birthweight, irrespective of place of birth, could substantially reduce neonatal and infant mortality. FUNDING: Research Council of Norway and University of Bergen.

Antenatal Uterotonics as a Risk Factor for Intrapartum Stillbirth and First-day Death in Haryana, India: A Nested Case-control Study.

BACKGROUND: Use of uterotonics like oxytocin to induce or augment labor has been shown to reduce placental perfusion and oxygen supply to the fetus, and studies indicate that it may increase the risk of stillbirth and neonatal asphyxia. Antenatal use of uterotonics, even without the required fetal monitoring and prompt access to cesarean section, is widespread, yet no study has adequately estimated the risk of intrapartum stillbirth and early neonatal deaths ascribed to such use. We conducted a case-control study to estimate this risk. METHODS: We conducted a population-based case-control study nested in a cluster-randomized trial. From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery. We visited all live-born infants on day 29 to ascertain whether they were alive. We conducted verbal autopsies for stillbirths and neonatal deaths. Cases (n = 2,076) were the intrapartum stillbirths and day-1 deaths (early deaths), and controls (n = 532) were live-born babies who died between day 8 and 28 (late deaths). RESULTS: Antenatal administration of uterotonics preceded 74% of early and 62% of late deaths, translating to an adjusted odds ratio (95% confidence interval [CI]) for early deaths of 1.7 (95% CI = 1.4, 2.1), and a population attributable risk of 31% (95% CI = 22%, 38%). CONCLUSIONS: Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death. See video abstract: http://links.lww.com/EDE/B707.

Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial.

BACKGROUND: In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy. METHOD: This RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment. RESULTS: In the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent. CONCLUSION: Our study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered.

Utilisation, equity and determinants of full antenatal care in India: analysis from the National Family Health Survey 4.

OBJECTIVES: We examined the utilisation, equity and determinants of full antenatal care (ANC), defined as 4 or more antenatal visits, at least one tetanus toxoid (TT) injection and consumption of iron folic acid (IFA) for a minimum of 100 days, in India. METHODS: We analysed a sample of 190,898 women from India's National Family Health Survey 4. Concentration curves and concentration index were used to assess equity in full ANC utilisation. Multivariable logistic regression model was used to examine the factors associated with full ANC utilisation. RESULTS: In India, 21% of pregnant women utilised full ANC, ranging from 2.3-65.9% across states. Overall, 51.6% had 4 or more ANC visits, 30.8% consumed IFA for atleast 100 days, and 91.1% had one or more doses of tetanus toxoid. Full ANC utilisation was inequitable across place of residence, caste and maternal education. Registration of pregnancy, utilisation of government's Integrated Child Development Services (ICDS) and health insurance coverage were associated with higher odds of full ANC utilisation. Lower maternal education, lower wealth quintile(s), lack of father's participation during antenatal visits, higher birth order, teenage and unintended pregnancy were associated with lower odds of full ANC utilisation. CONCLUSIONS: Full ANC utilisation in India was inadequate and inequitable. Although half of the women did not receive the minimum recommended ANC visits, the utilisation of TT immunisation was almost universal. The positive association of full ANC with ICDS utilisation and child's father involvement may be leveraged for increasing the uptake of full ANC. Strategies to address the socio-demographic factors associated with low and inequitable utilisation of full ANC are imperative for strengthening India's maternal health program.

Cognitive and motor outcomes in children born low birth weight: a systematic review and meta-analysis of studies from South Asia.

BACKGROUND: South Asia contributes substantially to global low birth weight population (i.e. those with birth weight < 2500 g). Synthesized evidence is lacking on magnitude of cognitive and motor deficits in low birth weight (LBW) children compared to those with normal birth weight (NBW) (i.e. birth weight ≥ 2500 g). The meta-analysis aimed to generate this essential evidence. METHODS: Literature search was performed using PubMed and Google Scholar. Original research articles from south Asia that compared cognitive and/or motor scores among LBW and NBW individuals were included. Weighted mean differences (WMD) and pooled relative risks (RR) were calculated. All analyses were done using STATA 14 software. RESULTS: Nineteen articles (n = 5999) were included in the analysis. Children < 10 years of age born LBW had lower cognitive (WMD -4.56; 95% CI: -6.38, - 2.74) and motor scores (WMD -4.16; 95% CI: -5.42, - 2.89) compared to children with NBW. Within LBW children, those with birth weight < 2000 g had much lower cognitive (WMD -7.23, 95% CI; - 9.20, - 5.26) and motor scores (WMD -6.45, 95% CI; - 9.64, - 3.27). CONCLUSIONS: In south Asia, children born LBW, especially with < 2000 g birth weight, have substantial cognitive and motor impairment compared to children with NBW. Early child development interventions should lay emphasis to children born LBW.

Severe wasting among Indian infants <6 months: Findings from the National Family Health Survey 4.

Burden and risk factors for wasting in the first 6 months of life among Indian children are not well documented. We used data from India's National Family Health Survey 4 to estimate the prevalence of severe wasting (weight for length < -3 SD) among 18,898 infants under 6 months of age. We also examined the association of severe wasting with household, maternal, and child-related factors using multivariable logistic regression analysis. Prevalence of severe wasting among infants less than 6 months of age was 14.8%, ranging from 3.5 to 21% across states. Low birth weight (<2,500 g; adjusted odds ratio [AOR] 1.40, 95% CI [1.19, 1.65]), nonutilization of supplementary nutrition by mother during lactation (AOR 1.23, 95% CI [1.05, 1.43]), and anthropometric assessment during summer (AOR 1.37, 95% CI [1.13, 1.65]) and monsoon months (AOR 1.53, 95% CI [1.20, 1.95]) were associated with higher odds of severe wasting. Infants aged 2 to 3 months (AOR 0.78, 95% CI [0.66, 0.93]) and 4 to 5 months (AOR 0.65, 95% CI [0.55, 0.73]) had lower odds of severe wasting as compared with the 0- to 1-month category. This analysis reveals a high burden of severe wasting in infants less than 6 months in India. Preventive interventions must be targeted at reducing low birth weight due to fatal growth restriction and prematurity. Appropriate care practices at facilities and postdischarge with extra attention to those born small and sick can prevent further deterioration in nutritional status.

Kangaroo mother care: using formative research to design an acceptable community intervention.

BACKGROUND: Low and middle income countries (LMICs), including India, contribute to a major proportion of low birth weight (LBW) infants globally. These infants require special care. Kangaroo Mother Care (KMC) in hospitals is a cost effective and efficacious intervention. In institutional deliveries, the duration of facility stay is often short. In LMICs, a substantial proportion of deliveries still occur at home and access to health care services is limited. In these circumstances, a pragmatic choice may be to initiate KMC at home for LBW babies. However, evidence is lacking on benefits of community-initiated KMC (cKMC). Promoting KMC at home without an understanding of its acceptability may lead to limited success. METHODS: We conducted formative research to assess the feasibility, acceptability and adoption of cKMC with the aim of designing an intervention package for a randomised controlled trial in LBW infants in Haryana, India. Qualitative methods included 40 in-depth interviews with recently delivered women and 6 focus group discussions, two each with fathers and grandfathers, grandmothers, and community health workers. A prototype intervention package to promote cKMC was developed and tested in 28 mother-infant pairs (of them, one mother had twins), using Household (HH) trials. RESULTS: We found that most mothers in the community recognized that babies born small required special care. In spite of not being aware of the practice of KMC, respondents felt that creating awareness of KMC benefits will promote practice. They expressed concerns about doing KMC for long periods because mothers needed rest after delivery. However, the cultural practice of recently delivered women not expected to be doing household chores and availability of other family members were identified as enablers. HH trials provided an opportunity to test the intervention package and showed high acceptability for KMC. Most mothers perceived benefits such as weight gain and increased activity in the infant. CONCLUSIONS: Community-initiated KMC is acceptable by mothers and adoption rates are high. Formative research is essential for developing a strategy for delivery of an intervention. TRIAL REGISTRATION: Trial registration number CTRI/2015/10/006267 . Name of Registry: Clinical Trials Registry - India. URL of Registry: http://ctri.nic.in/Clinicaltrials/login.php Date of Registration: 15/10/2015. Date of enrolment of the first participant to the trial: 18/04/2015.

Low-birthweight infants born to short-stature mothers are at additional risk of stunting and poor growth velocity: Evidence from secondary data analyses.

Low-birthweight (LBW) infants are at an increased risk of stunting and poor linear growth. The risk might be additionally higher in these infants when born to short mothers. However, this hypothesis has been less explored. The objective of this secondary data analysis was to determine the risk of linear growth faltering and difference in linear growth velocity in LBW infants born to short mothers (<150 cm) compared to those born to mothers with height ≥150 cm during the first year of life. This analysis uses data from a community-based randomized controlled trial of 2,052 hospital-born term infants with birthweight ≤2,500g from urban low-middle socioeconomic neighbourhoods in Delhi, India. Data on maternal height and infant birth length were available from 1,858 (90.5%) of the infants. Infant anthropometry outcomes were measured at birth, 3, 6, 9, and 12 months of age. We found that infants born to short mothers had around twofold higher odds of stunting and lower attained length-for-age Z scores compared to infants of mothers with height ≥150 cm, at all ages of assessment. Linear growth velocity was significantly lower in infants of short mothers particularly in the first 6 months of life. We conclude that LBW infants born to short mothers are at a higher risk of stunting and have slower postnatal growth velocity resulting in lower attained length-for-age Z scores in infancy. Evidence-based strategies need to be tested to optimize growth velocity in LBW infants especially those born to short mothers.

Why invest, and what it will take to improve breastfeeding practices?

Despite its established benefits, breastfeeding is no longer a norm in many communities. Multifactorial determinants of breastfeeding need supportive measures at many levels, from legal and policy directives to social attitudes and values, women's work and employment conditions, and health-care services to enable women to breastfeed. When relevant interventions are delivered adequately, breastfeeding practices are responsive and can improve rapidly. The best outcomes are achieved when interventions are implemented concurrently through several channels. The marketing of breastmilk substitutes negatively affects breastfeeding: global sales in 2014 of US$44·8 billion show the industry's large, competitive claim on infant feeding. Not breastfeeding is associated with lower intelligence and economic losses of about $302 billion annually or 0·49% of world gross national income. Breastfeeding provides short-term and long-term health and economic and environmental advantages to children, women, and society. To realise these gains, political support and financial investment are needed to protect, promote, and support breastfeeding.

Integrated Interventions Delivered in Health Systems, Home, and Community Have the Highest Impact on Breastfeeding Outcomes in Low- and Middle-Income Countries.

Background: Improving breastfeeding rates is critical. In low- and middle-income countries (LMICs), only subtle improvements in breastfeeding rates have been observed over the past decade, which highlights the need for accelerating breastfeeding promotion interventions.Objective: The objective of this article is to update evidence on the effect of interventions on early initiation of and exclusive (<1 and 1-5 mo) and continued (6-23 mo) breastfeeding rates in LMICs when delivered in health systems, in the home or in community environments, or in a combination of settings.Methods: A systematic literature search was conducted in PubMed, Cochrane, and CABI databases to identify new articles relevant to our current review, which were published after the search date of our earlier meta-analysis (October 2014). Nine new articles were found to be relevant and were included, in addition to the other 52 studies that were identified in our earlier meta-analysis. We reported the pooled ORs and corresponding 95% CIs as our outcome estimates. In cases of high heterogeneity, random-effects models were used and causes were explored by subgroup analysis and meta-regression.Results: Early initiation of and exclusive (<1 and 1-5 mo) and continued (6-23 mo) breastfeeding rates in LMICs improved significantly as a result of interventions delivered in health systems, in the home or community, or a combination of these. Interventions delivered concurrently in a combination of settings were found to show the largest improvements in desired breastfeeding outcomes. Counseling provided in any setting and baby-friendly support in health systems appear to be the most effective interventions to improve breastfeeding.Conclusions: Improvements in breastfeeding practices are possible in LMICs with judicious use of tested interventions, particularly when delivered in a combination of settings concurrently. The findings can be considered for inclusion in the Lives Saved Tool model.

Effect of childhood nutrition counselling on intelligence in adolescence: a 15-year follow-up of a cluster-randomised trial.

OBJECTIVE: The present study aimed to assess the effects of an early childhood nutrition counselling intervention on intelligence (as measured by the intelligence quotient (IQ)) at age 15-16 years. DESIGN: A single-blind, cluster-randomised trial. SETTING: In 1998, in Southern Brazil, mothers of children aged 18 months or younger were enrolled in a nutrition counselling intervention (n 424). Counselling included encouragement and promotion of exclusive breast-feeding until 6 months of age and continued breast-feeding supplemented by protein-, lipid- and carbohydrate-rich foods after age 6 months up to age 2 years. The control group received routine feeding advice. In 2013, the fourth round of follow-up of these individuals, at the age of 15-16 years, was undertaken. IQ was assessed using the short form of the Wechsler Adult Intelligence Scale (WAIS-III). Mental disorders (evaluated using the Development and Well-Being Assessment (DAWBA)) and self-reported school failure, smoking and alcohol use were also investigated. Adjusted analyses were conducted using a multilevel model in accordance with the sampling process. SUBJECTS: Adolescents, mean (sd) age of 15·4 (0·5) years (n 339). RESULTS: Mean (sd) total IQ score was lower in the intervention group than the control group (93·4 (11·4) and 95·8 (11·2), respectively) but the association did not persist after adjustment. The prevalence of any mental disorders was similar between intervention and control groups (23·1 and 23·5 %, respectively). There were no differences between groups regarding school failure, smoking and alcohol use. CONCLUSIONS: Nutrition counselling intervention in early childhood had no effect on intelligence measured during adolescence.

Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Supplementation 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). METHODS: We 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. FINDINGS: Between 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. INTERPRETATION: Neonatal 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. FUNDING: Bill & Melinda Gates Foundation to WHO.

Efficacy of early neonatal supplementation with vitamin A to reduce mortality in infancy in Haryana, India (Neovita): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Vitamin A supplementation in children aged 6 months to 5 years has been shown to reduce mortality. The efficacy of neonatal supplementation with vitamin A to reduce mortality in the first 6 months of life is plausible but not established. We aimed to assess the efficacy of neonatal oral supplementation with vitamin A to reduce mortality between supplementation and 6 months of age. METHODS: We undertook an individually randomised, double-blind, placebo-controlled trial in Haryana, India. We identified pregnant women through a surveillance programme undertaken every 3 months of all female residents in two districts of Haryana, India, aged 15-49 years, and screened every identified livebirth. Eligible participants were neonates whose parents consented to participate, were likely to stay in the study area until at least 6 months of age, and were able to feed orally at the time of enrolment. Participants were randomly assigned to receive oral capsules containing vitamin A (retinol palmitate 50,000 IU plus vitamin E 9·5-12·6 IU) or placebo (vitamin E 9·5-12·6 IU) within 72 h of birth. Randomisation was in blocks of 20 according to a randomisation list prepared by a statistician not otherwise involved with the trial. Investigators, participants' families, and the data analysis team were masked to treatment allocation. The primary outcome was mortality between supplementation and 6 months of age. Analysis included all participants assigned to study groups. This trial is registered with ClinicalTrials.gov, number NCT01138449, and the Indian Council of Medical Research Clinical Trial Registry, number CTRI/2010/091/000220. FINDINGS: Between June 24, 2010, and July 1, 2012 we screened 47,777 neonates and randomly assigned 44,984 to receive vitamin A (22,493) or placebo (22,491). Between supplementation and 6 months of age, 656 infants died in the vitamin A group compared with 726 in the placebo group (29·2 per 1000 vs 32·3 per 1000; difference -3·1 per 1000, 95% CI -6·3 to 0·1; risk ratio 0·90, 95% CI 0·81 to 1·00). We noted no significant interactions between the intervention effect and sex on mortality at 6 months (p=0·409). Supplementation with 50,000 IU vitamin A within the first 72 h of life was generally safe and well tolerated, with the exception of a small excess risk of transient bulging fontanelle (205 cases in the vitamin A group confirmed by physician vs 80 cases in the placebo group, risk ratio 2·56 [95% CI 1·98-3·32]). INTERPRETATION: The findings of this study, done in a population in which vitamin A deficiency is a moderate public health problem, are consistent with a modest reduction in mortality between supplementation and 6 months of age. These findings must be viewed together with similar trials in other populations to enable determination of appropriate public health policy. FUNDING: Bill & Melinda Gates Foundation to WHO.