Abstract
BACKGROUND: Treatment of growth faltering in early infancy may improve short and long term child health outcomes. The overall aim of this trial is to determine, in infants who meet study criteria for growth faltering, the effect of intensive breastfeeding counselling and support (IBFCS) plus nutritional milk supplementation (NMS) compared with IBFCS alone, on mortality, morbidity and growth at 6 completed months in low resource settings in South Asia and Sub-Saharan Africa. The primary outcome of the trial is wasting free survival (alive without wasting (weight for length standard deviation score < - 2 standard deviations (SD))) at 6 completed months of age. METHODS: This is a multi-centre, parallel-group, individually-randomized, non-blinded, controlled trial implemented in seven countries: three in Asia (Bangladesh, India and Pakistan) and four in Africa (Ethiopia, Nigeria, Tanzania and Uganda). Eleven thousand (11,000) infants with a gestational age of at least 28 weeks are enrolled and individually randomised between 7 and 14 days of age. The mother of each infant receives breastfeeding support from trained peer counsellors. Research workers follow up each infant 1-2 weekly at the infant's home to collect growth and outcome data. If infants meet study criteria for growth problems (slow weight gain, growth concern or growth faltering) they are reviewed by study clinicians, their medical problems are treated, and their mothers receive IBFCS. Infants with growth faltering in the intervention arm also receive nutritional milk supplementation (NMS) (prescribed quantities of term infant formula that meets Codex Alimentarius standards calculated to fulfill the needs for catch up growth). The comparison group receives IBFCS alone. Weekly growth monitoring continues and final outcome data (mortality, wasting) are measured in all infants at 6 completed months. DISCUSSION: This large randomised trial will provide evidence about the role of NMS, if any, in infants with growth faltering who do not respond to IBFCS and treatment of medical problems in low resource settings. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ANZCTR) CTRN12624000704594. Registered on June 4 2024.