Technical report: Trial experience and data capture in the Low Birth Weight South Asia Trial, a large cluster-randomised controlled trial in lowland Nepal

Objectives: i) to describe data capture in the Low Birth Weight South Asia Trial (LBWSAT) and factors affecting it; ii) to analyse to what extent differential data capture created bias in the available data. Methods: We describe the context, study design, data collection instruments used and their capture rates. Little of the data available were eligible for trial analyses, so use of the data for secondary analyses is important. Data capture was affected by data collector overload, pressure to enrol women in the food and cash transfer arms, delayed receipt of participant ID cards, enrolment of women at any gestational age (including after delivery at the start), in-migration into the food/cash arms to access transfers, political instability, conflict in the field team, logistical issues, establishment of a run-in period, hiatus of data collection during training, and lack of funds to extend the duration of the study. To assess the extent that differential data capture generated bias we described background characteristics by study arm and in-migration status. Then for each of the main data collection instruments we compared captured and not-captured enrolled women’s age, age at marriage, wealth score and height using t-tests and enrolled women’s and husband’s education using chi squared tests. Using mixed logistic regressions (adjusted for clustering using random effects) we assessed the odd of questionnaire capture in relation to these factors. Results: Small differences between captured and non-captured women were found. In-migrators were more prevalent in the cash/food transfer arms and compared with permanent residents were more likely to be living in their parental homes, younger, primigravida, adolescent, Muslim, slightly poorer and have some education. Analyses of captured and non-captured women by questionnaire revealed small differences in age, age at marriage, wealth score and education but mostly these differences were very small. The largest differences were between captured and non-captured women in the endline cross-sectional survey, when slightly older, less educated, poorer women were more likely to be captured. These women more likely to report to a measuring station in their community. Conclusions: Many challenges in implementing large-scale trials in the plains of Nepal affect rates of data capture, especially when several timebound follow-up data collection occasions are needed. Although in-migrated and permanent residents, and captured and non-captured women differed slightly, the differences were not large enough to be of concern

Acceptability and Reliability of the Bayley Scales of Infant Development III Cognitive and Motor Scales among Children in Makwanpur

BACKGROUND: The Bayley Scales of Infant Development III (BSID III) is an instrument to measure the development of children aged 1-42 months. Our study sought to assess the feasibility and reliability of the BSID III's cognitive and motor sub-scales among children in rural Nepal. METHODS: For this study, translation and back translation in Nepali and English for cognitive and motor sub-scale of BSID III were done. Two testers assessed a total of 102 children aged 1-42 months and were video-recorded and rescored by the third tester. Raw scores were calculated for each assessment. Inter and intra-observer reliability of scores across the three testers was examined. Raw score was converted into scaled score to examine the mean score. The study received ethical clearance from NHRC. RESULTS: A total of 102 children were assessed. The inter-rater reliability of the BSID III among three testers using the Intraclass Correlation Coefficient by age group was 0.997 (95% CI: 0.996-0.998) for the cognitive scale, 0.997 (95% CI: 0.996- 0.998) for the gross motor scale, and 0.998 (95% CI: 0.997- 0.999) for the fine motor scale. All were statistically significant (p< 0.0001). The mean scaled cognitive, fine motor and gross motor development scores in this group of children were 8.3 (SD: 2.5), 8.5 (SD: 2.6) and 9.5 (3.2), respectively. CONCLUSIONS: Assessing the cognitive and motor development of children under five using the BSID III was feasible in Makwanpur district, Nepal. The inter-rater reliability was highly comparable among the three testers

Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

Background: Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen.Methods/Design: The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers.MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design.MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs) are supported in convening monthly women's groups. Nine groups per cluster (270 in total) work through two action research cycles in which they (i) identify local issues around maternity, newborn health and nutrition, (ii) prioritise key problems, (iii) develop strategies to address them, (iv) implement the strategies, and (v) evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i) identify local births, (ii) identify low birth weight infants, (iii) identify possible newborn infection, (iv) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v) follow up infants and support families.Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal diet, breastfeeding and complementary feeding practices, maternal and under-2 anthropometric status. MIRA Dhanusha sepsis management: identification and treatment of neonatal sepsis by community health volunteers, infection-specific neonatal mortality

Change in cost and affordability of a typical and nutritionally adequate diet among socio-economic groups in rural Nepal after the 2008 food price crisis

Diet quality is an important determinant of nutrition and food security and access can be constrained by changes in food prices and affordability. Poverty, malnutrition, and food insecurity are high in Nepal and may have been aggravated by the 2008 food price crisis. To assess the potential impact of the food price crisis on the affordability of a nutritionally adequate diet in the rural plains of Nepal, data on consumption patterns and local food prices were used to construct typical food baskets, consumed by four different wealth groups in Dhanusha district in 2005 and 2008. A modelled diet designed to meet household requirements for energy and essential nutrients at minimum cost, was also constructed using the ‘Cost of Diet’ linear programming tool, developed by Save the Children. Between 2005 and 2008, the cost of the four typical food baskets increased by 19% – 26% and the cost of the nutritionally adequate modelled diet increased by 28%. Typical food baskets of all wealth groups were low in macro and micronutrients. Income data for the four wealth groups in 2005 and 2008 were used to assess diet affordability. The nutritionally adequate diet was not affordable for poorer households in both 2005 and 2008. Due to an increase in household income levels, the affordability scenario did not deteriorate further in 2008. Poverty constrained access to nutritionally adequate diets for rural households in Dhanusha, even before the 2008 food price crisis. Despite increased income in 2008, households remain financially unable to meet their nutritional requirements

Food security, food price and income trends in Dhanusha district, Nepal between 2005 and 2011

Household food security is determined by availability, access and utilisation of food. Although the Terai is Nepal’s ‘bread basket’, the poor lack access to foods. Hence, in Dhanusha district, MIRA/UCL monitored food security and related factors between 2005‐6 and 2011 as part of prospective surveillance of households with recently delivered women

STUDY OF GROWTH PROMOTING EFFECTS OF AYU-707 - A POLYHERBAL POWDER IN IMMATURE RATS

ABSTRACTObjective: The growth promoting effects of AYU-707 was investigated in 1 and 2 months immature rats.Methods: The AYU-707 was administered orally at a dose of 5 (1-month-old rats) and 6.5 g/kg body weight (BW) (2-month-old rats) for 45 days.During and end of the study, BW, tail length, body circumference, and feed efficiency were determined. After 24 hrs of the last treatment, the bloodwas withdrawn by retro-orbital puncture and blood, hemoglobin, serum alkaline phosphatase, serum glutamate-oxaloacetate transaminase, serumglutamic-pyruvic transaminase, calcium, total protein, and amylase were estimated. Then, the rats were sacrificed by overdose ketamine and thefemur weight, tibial density, bone hydroxyproline content, and epiphyseal plate width were determined. Then, the spleen, lung, liver, kidney, heart,and uterus weights were determined.Results: The preliminary phytochemical investigation confirms the presence of carbohydrate, amino acid, alkaloids, flavonoids, and tannins in AYU707powder.The ratstreatedwith AYU-707haveshownsignificantdifferencesin most of the growthenhancementparameterswhencomparedtothenormal rats.Conclusion: From the results of the present study, it is concluded that AYU-707 formulated by M/s Ayurwin Pharma Pvt. Ltd., Bengaluru, possessessuperior anabolic and growth promotion properties that may serve to promote the growth in children associated with growth-related disorders.Keywords: Body circumference, Tibial density, Flavonoids, Hydroxyproline, Epiphyseal plate

Validating an Agency-based Tool for Measuring Women’s Empowerment in a Complex Public Health Trial in Rural Nepal

Despite the rising popularity of indicators of women’s empowerment in global development programmes, little work has been done on the validity of existing measures of such a complex concept. We present a mixed methods validation of the use of the Relative Autonomy Index for measuring Amartya Sen’s notion of agency freedom in rural Nepal. Analysis of think-aloud interviews (n = 7) indicated adequate respondent understanding of questionnaire items, but multiple problems of interpretation including difficulties with the four-point Likert scale, questionnaire item ambiguity and difficulties with translation. Exploratory Factor Analysis of a calibration sample (n = 519) suggested two positively correlated factors (r = 0.64) loading on internally and externally motivated behaviour. Both factors increased with decreasing education and decision-making power on large expenditures and food preparation. Confirmatory Factor Analysis on a validation sample (n = 509) revealed good fit (Root Mean Square Error of Approximation 0.05–0.08, Comparative Fit Index 0.91–0.99). In conclusion, we caution against uncritical use of agency-based quantification of women’s empowerment. While qualitative and quantitative analysis revealed overall satisfactory construct and content validity, the positive correlation between external and internal motivations suggests the existence of adaptive preferences. High scores on internally motivated behaviour may reflect internalized oppression rather than agency freedom

Causes of stillbirths and neonatal deaths in Dhanusha district, Nepal: A verbal autopsy study

Background: Perinatal (stillbirths and first week neonatal deaths) and neonatal (deaths in the first 4 weeks) mortality rates remain high in developing countries like Nepal. As most births and deaths occur in the community, an option to ascertain causes of death is to conduct verbal autopsy. Objective: The objective of this study was to classify and review the causes of stillbirths and neonatal deaths in Dhanusha district, Nepal. Materials and Methods: Births and neonatal deaths were identified prospectively in 60 village development committees of Dhanusha district. Families were interviewed at six weeks after delivery, using a structured questionnaire. Cause of death was assigned independently by two pediatricians according to a predefined algorithm; disagreement was resolved in discussion with a consultant neonatologist. Results: There were 25,982 deliveries in the 2 years from September 2006 to August 2008. Verbal autopsies were available for 601/813 stillbirths and 671/954 neonatal deaths. The perinatal mortality rate was 60 per 1000 births and the neonatal mortality rate 38 per 1000 live births. 84% of stillbirths were fresh and obstetric complications were the leading cause (67%). The three leading causes of neonatal death were birth asphyxia (37%), severe infection (30%) and prematurity or low birth weight (15%). Most infants were delivered at home (65%), 28% by relatives. Half of women received an injection (presumably an oxytocic) during home delivery to augment labour. Description of symptoms commensurate with birth asphyxia was commoner in the group of infants who died (41%) than in the surviving group (14%). Conclusion: The current high rates of stillbirth and neonatal death in Dhanusha suggest that the quality of care provided during pregnancy and delivery remains sub-optimal. The high rates of stillbirth and asphyxial mortality imply that, while efforts to improve hygiene need to continue, intrapartum care is a priority. A second area for consideration is the need to reduce the uncontrolled use of oxytocic for augmentation of labour