inSCALE Baseline Cross-Sectional Survey Uganda

A data collection containing information on 6,501 children under 5 years of age in West Uganda. Data was collected during May - August 2011 as part of a baseline survey prior to implementation of the inSCALE c-RCT in the site. Dataset variables cover socioeconomic and demographic characteristics of households, symptoms of the most recent illness episode for the children during the two weeks preceding the survey, care seeking behaviour, treatments received and details of all self-reported out-of-pocket costs associated with care seeking for the episode of illness. Three datasets are made available: [1] The ‘inSCALE_baseline’ master table covers 1 child per row, and [2] a ‘inSCALE_long_baseline’ table with 1 illness condition per row (if child had more than one illness defined, one row is created for each illness) (5057 - only sick children included hence lower total), and [3] 'inSCALE_baseline_extra_cost' table containing additional data on household direct and indirect costs of care seeking collected in the baseline survey

Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial.

BACKGROUND: In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. METHODS: The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. FINDINGS: 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12-1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02-1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07-1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85-2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27-2·13; p<0·0001), exclusive breastfeeding for 26-32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04-1·16; p=0·001), and baby sleeping under bednet for 8-56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03-1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75-1·12; p=0·405). INTERPRETATION: The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5-18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions. FUNDING: WHO, Bill & Melinda Gates Foundation, and UK Department for International Development

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries

OBJECTIVE: To assess the rates, timing and causes of neonatal deaths and the burden of stillbirths in rural Uttar Pradesh, India. We discuss the implications of our findings for neonatal interventions. METHODS: We used verbal autopsy interviews to investigate 1048 neonatal deaths and stillbirths. FINDINGS: There were 430 stillbirths reported, comprising 41% of all deaths in the sample. Of the 618 live births, 32% deaths were on the day of birth, 50% occurred during the first 3 days of life and 71% were during the first week. The primary causes of death on the first day of life (i.e. day 0) were birth asphyxia or injury (31%) and preterm birth (26%). During days 1–6, the most frequent causes of death were preterm birth (30%) and sepsis or pneumonia (25%). Half of all deaths caused by sepsis or pneumonia occurred during the first week of life. The proportion of deaths attributed to sepsis or pneumonia increased to 45% and 36% during days 7–13 and 14–27, respectively. CONCLUSION: Stillbirths and deaths on the day of birth represent a large proportion of perinatal and neonatal deaths, highlighting an urgent need to improve coverage with skilled birth attendants and to ensure access to emergency obstetric care. Health interventions to improve essential neonatal care and care-seeking behavior are also needed, particularly for preterm neonates in the early postnatal period

Association between probable postnatal depression and increased infant mortality and morbidity: findings from the DON population-based cohort study in rural Ghana.

OBJECTIVES: To assess the impact of probable depression in the immediate postnatal period on subsequent infant mortality and morbidity. DESIGN: Cohort study nested within 4 weekly surveillance of all women of reproductive age to identify pregnancies and collect data on births and deaths. SETTING: Rural/periurban communities within the Kintampo Health Research Centre study area of the Brong-Ahafo Region of Ghana. PARTICIPANTS: 16,560 mothers who had a live singleton birth reported between 24 March 2008 and 11 July 2009, who were screened for probable postnatal depression (pPND) between 4 and 12 weeks post partum (some of whom had also had depression assessed at pregnancy), and whose infants survived to this point. PRIMARY/SECONDARY OUTCOME MEASURES: All-cause early infant mortality expressed per 1000 infant-months of follow-up from the time of postnatal assessment to 6 months of age. The secondary outcomes were (1) all-cause infant mortality from the time of postnatal assessment to 12 months of age and (2) reported infant morbidity from the time of the postnatal assessment to 12 months of age. RESULTS: 130 infant deaths were recorded and singletons were followed for 67,457.4 infant-months from the time of their mothers' postnatal depression assessment. pPND was associated with an almost threefold increased risk of mortality up to 6 months (adjusted rate ratio (RR), 2.86 (1.58 to 5.19); p=0.001). The RR up to 12 months was 1.88 (1.09 to 3.24; p=0.023). pPND was also associated with increased risk of infant morbidity. CONCLUSIONS: There is new evidence for the association between maternal pPND and infant mortality in low-income and middle-income countries. Implementation of the WHO's Mental Health Gap Action Programme (mhGAP) to scale up packages of care integrated with maternal health is encouraged as an important adjunct to child survival efforts

Association between probable postnatal depression and increased infant mortality and morbidity: findings from the DON population-based cohort study in rural Ghana.

OBJECTIVES: To assess the impact of probable depression in the immediate postnatal period on subsequent infant mortality and morbidity. DESIGN: Cohort study nested within 4 weekly surveillance of all women of reproductive age to identify pregnancies and collect data on births and deaths. SETTING: Rural/periurban communities within the Kintampo Health Research Centre study area of the Brong-Ahafo Region of Ghana. PARTICIPANTS: 16,560 mothers who had a live singleton birth reported between 24 March 2008 and 11 July 2009, who were screened for probable postnatal depression (pPND) between 4 and 12 weeks post partum (some of whom had also had depression assessed at pregnancy), and whose infants survived to this point. PRIMARY/SECONDARY OUTCOME MEASURES: All-cause early infant mortality expressed per 1000 infant-months of follow-up from the time of postnatal assessment to 6 months of age. The secondary outcomes were (1) all-cause infant mortality from the time of postnatal assessment to 12 months of age and (2) reported infant morbidity from the time of the postnatal assessment to 12 months of age. RESULTS: 130 infant deaths were recorded and singletons were followed for 67,457.4 infant-months from the time of their mothers' postnatal depression assessment. pPND was associated with an almost threefold increased risk of mortality up to 6 months (adjusted rate ratio (RR), 2.86 (1.58 to 5.19); p=0.001). The RR up to 12 months was 1.88 (1.09 to 3.24; p=0.023). pPND was also associated with increased risk of infant morbidity. CONCLUSIONS: There is new evidence for the association between maternal pPND and infant mortality in low-income and middle-income countries. Implementation of the WHO's Mental Health Gap Action Programme (mhGAP) to scale up packages of care integrated with maternal health is encouraged as an important adjunct to child survival efforts

Maximizing community participation and engagement: lessons learned over 2 decades of field trials in rural Ghana

BACKGROUND: Successful implementation of community-based research is dominantly influenced by participation and engagement from the local community without which community members will not want to participate in research and important knowledge and potential health benefits will be missed. Therefore, maximising community participation and engagement is key for the effective conduct of community-based research. In this paper, we present lessons learnt over two decades of conducting research in 7 rural districts in the Brong Ahafo region of Ghana with an estimated population of around 600,000. The trials which were mainly in the area of Maternal, Neonatal and Child Health were conducted by the Kintampo Health Research Centre (KHRC) in collaboration with the London School of Hygiene and Tropical Medicine (LSHTM). METHODS: The four core strategies which were used were formative research methods, the formation of the Information, Education and Communication (IEC) team to serve as the main link between the research team and the community, recruitment of field workers from the communities within which they lived, and close collaboration with national and regional stakeholders. RESULTS: These measures allowed trust to be built between the community members and the research team and ensured that potential misconceptions which came up in the communities were promptly dealt with through the IEC team. The decision to place field workers in the communities from which they came and their knowledge of the local language created trust between the research team and the community. The close working relationship between the District health authorities and the Kintampo Health Research Centre supported the acceptance of the research in the communities as the District Health Authorities were respected and trusted. CONCLUSION: The successes achieved during the past 2 decades of collaboration between LSHTM and KHRC in conducting community-based field trials were based on involving the community in research projects. Community participation and engagement helped not only to identify the pertinent issues, but also enabled the communities and research team to contribute towards efforts to address challenges

Cost and cost-eff ectiveness of newborn home visits: fi ndings from the Newhints cluster-randomised controlled trial in rural Ghana

Background Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5–18). We aimed to estimate the costs and cost-eff ectiveness of newborn home visits in a programme setting. Methods We prospectively collected detailed cost data alongside the Newhints trial, which tested the eff ect of a homevisits intervention in seven districts in rural Ghana and showed a reduction of 8% (95% CI –12 to 25%) in neonatal mortality. The intervention consisted of a package of home visits to pregnant women and their babies in the fi rst week of life by community-based surveillance volunteers. We calculated incremental cost-eff ectiveness ratios (ICERs) with Monte Carlo simulation and one-way sensitivity analyses and characterised uncertainty with cost-eff ectiveness planes and cost-eff ectiveness acceptability curves. We then modelled the potential cost-eff ectiveness for baseline neonatal mortality rates of 20–60 deaths per 1000 livebirths with use of a meta-analysis of eff ectiveness estimates. Findings In the 49 zones randomly allocated to receive the Newhints intervention, a mean of 407 (SD 18) communitybased surveillance volunteers undertook home visits for 7848 pregnant women who gave birth to 7786 live babies in 2009. Annual economic cost of implementation was US$203 998, or$0·53 per person. In the base-case analysis, the Newhints intervention cost a mean of $10 343 (95$352 (95% CI 104 to –268) per discounted life-year saved, and had a 72% chance of being highly cost eff ective with respect to Ghana’s 2009 gross domestic product per person. Key determinants of cost-eff ectiveness were the discount rate, protective eff ectiveness, baseline neonatal mortality rate, and implementation costs. In the scenarios modelled with the meta-analysis results, the ICER increased from $127 per life-year saved at a neonatal mortality rate of 60 deaths per 1000 livebirths, to$379 per life-year saved at a rate of 20 deaths per 1000 livebirths. The strategy had at least a 99% probability of being highly cost eff ective for lower-middle-income countries in all neonatal mortality rate scenarios modelled, and at least a 95% probability of being highly cost eff ective for low-income countries at neonatal mortality rates of 30 or more deaths per 1000 livebirths. Interpretation Our fi ndings show that the seemingly modest mortality reductions achieved by a newborn home-visit strategy might in fact be cost eff ective. In Ghana, such strategies are also likely to be aff ordable. Our fi ndings support recommendations from WHO and UNICEF that low-income and middle-income countries implement newborn home visits

The contribution of childhood adversity to cortisol measures of early life stress amongst infants in rural India: findings from the early life stress sub-study of the SPRING cluster randomised controlled trial (SPRING-ELS)

Background: The majority of the world’s children live in low- and middle-income countries and face multiple obstacles to optimal wellbeing. The mechanisms by which adversities – social, cultural, psychological, environmental, economic – get ‘under the skin’ in the early days of life and become biologically embedded remain an important line of enquiry. We therefore examined the contribution of childhood adversity through pregnancy and the first year of life to hair and salivary cortisol measures of early life stress in the India SPRING home visits cluster RCT which aims to improve early childhood development. Methods: We assessed 22 adversities across four domains: socioeconomic, maternal stress, family-child relationship, and child and summed them to make a cumulative adversity score & quintiles, and four subscale scores. We cut 3 cm of hair from the posterior vertex and took three saliva samples from morning till late afternoon on each of two days (total six samples). We analysed both for cortisol concentration using ELISA techniques. We used multiple linear regression techniques to assess the relationship between cumulative adversity and log hair cortisol concentration and saliva diurnal slope and area under the curve. Results: We assessed 712 children for hair, and 752 children for saliva cortisol at 12 months of age. We found a strong positive relationship between adversity and hair cortisol; each additional adversity factor was associated with hair cortisol increases of 6.1% (95% CI 2.8, 9.4, p < 0.001) and the increase from adversity quintile one to five was 59.4%. Socioeconomic, relationship and child scales were independent predictors of hair cortisol (socioeconomic 6.4% (95% CI -0.4, 13.6); relationship 11.8% (95% CI 1.4, 23.2); child 7.9% (95% CI -0.5, 16.9). We did not find any association between any measures of adversity and either of the saliva cortisol outcomes. Discussion: This is the largest study of hair cortisol in young children, and the first in a low- and middle-income country setting. Whilst the short-term diurnal measures of cortisol did not appear to be linked with adversity, chronic exposure over several months appears to be strongly associated with cumulative adversity. These findings should spur further work to understand the specific ways in which adversity becomes biologically embedded, and how this can be tackled. They also lend support to ongoing action to tackle childhood adversity in communities around the world

Using the Mothers Object Relations Scale for early childhood development research in rural India: Findings from the Early Life Stress Sub-study of the SPRING Cluster Randomised Controlled Trial (SPRING-ELS).

BACKGROUND: The World Health Organization and others promote responsive caregiving to support all children to thrive, particularly in low- and middle-income countries. The 14-item Mother's Object Relations Scales - Short Form (MORS-SF) may be of use in research and public health programmes because of its basis in attachment theory and ability to capture parental feelings towards their child. METHODS: We culturally adapted the MORS-SF for use with mothers in the SPRING home visits trial when their infants were 12 months old. The same dyads were assessed using the HOME inventory concurrently and Bayley Scales of Infant Development III (BSID-III) at 18 months of age. Mixed effects linear regression was used to examine associations between MORS-SF (explanatory variable) and HOME-IT, and the cognitive, language and motor domains of BSID-III (outcome variables). RESULTS: 1273 dyads completed all assessments. For the motor and language BSID-III scales and for HOME-IT there were strong and positive associations with the MORS-SF warmth sub-scale, and strong and negative associations with the invasion sub-scale. Important but less strong associations were seen with the BSID-III cognitive scale. Evidence of interaction suggested that both are individually important for child development. CONCLUSIONS: This is the first time MORS-SF has been used in India where optimising responsive caregiving is of importance in supporting all children to reach their potential. It is also the first time that the tool has been used in relation to child development. MORS-SF could be a valuable addition to evaluation in early childhood development

Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania.

BACKGROUND: We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%. METHODS AND FINDINGS: In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant's life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0-27) per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9-1.2, p = 0.339). Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7,008, OR 1.4, CI 1.3-1.6, p < 0.001), feeding only breast milk for the first 3 d (90% of 7,557 versus 79% of 7,307, OR 2.2, 95% CI 1.8-2.7, p < 0.001), and clean hands for home delivery (92% of 1,351 versus 88% of 1,799, OR 1.5, 95% CI 1.0-2.3, p = 0.033). Facility delivery improved dramatically in both groups from 41% of 22,243 in 2007 and was 82% of 7,820 versus 75% of 7,553 (OR 1.5, 95% CI 1.2-2.0, p = 0.002) in intervention and comparison wards in 2013. Methodological limitations include our inability to rule out some degree of leakage of the intervention into the comparison areas and response bias for newborn care behaviours. CONCLUSION: Neonatal mortality remained high despite better care practices and childbirth in facilities becoming common. Public health action to improve neonatal survival in this setting should include a focus on improving the quality of facility-based childbirth care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01022788