Davanagere

Researchers are evaluating the effects of routinely feeding fortified human milk using a standardized clinical protocol to very low birthweight or very preterm infants admitted to neonatal intensive care units (NICUs) in India. The study aims to see if this feeding method improves growth outcomes by discharge and at 3 months of age, reduces illness by discharge, and lowers mortality by discharge and at one month, compared to infants who do not receive routinely fortified human milk. The study randomly assigns eligible infants and their mothers to either an intervention group receiving human milk fortified per manufacturer instructions for at least 21 days or a comparison group not receiving fortified milk, while both groups follow a clinical feeding guideline with volume targets. Infants must reach a minimum human milk intake of 60 mL/kg/day to be randomized, and feeding continues following the guideline until stopping criteria are met, such as transition to full breastfeeding or discharge. Mothers receive access to breast pumps and supportive care including lactation counseling and hygiene components. Participants are screened within 24 to 48 hours of birth, with data collected daily including feeding logs. Follow-up visits occur at 2 weeks, 4 weeks, and 3 months of age to monitor growth measured by length-for-age Z score at 3 months, illness, and survival. The study includes ongoing clinical monitoring and safety interventions as needed, with total participation lasting until at least 3 months of age or hospital discharge.