Randomized Trial of Fortifying Human Milk for Very Low Birthweight and Very Preterm Infants in Indian NICUs Using a Standardized Feeding Protocol

What this Trial Is About

Researchers are studying very low birthweight VLBW or very preterm VPT infants admitted to neonatal intensive care units NICU in India to see if feeding them fortified human milk using a standardized clinical protocol improves growth and reduces illness and mortality compared to feeding non-fortified human milk. This trial aims to improve feeding and growth outcomes in these vulnerable infants by evaluating this feeding approach in a randomized controlled setting. Participants will be randomly assigned after reaching a minimum daily intake of 60 mLkg of human milk to either receive fortified human milk with human milk fortifier HMF or non-fortified human milk. Mothers will express milk or provide pasteurized donor human milk, with fortification applied for at least 21 days in the intervention group. Both groups receive guideline-driven standard care including lactation support, feeding counseling, kangaroo mother care KMC, and hygiene components. Feeding targets and stopping criteria guide the duration of intervention, which ends upon transition to exclusive direct breastfeeding or discharge. Mothers and infants will be screened shortly after birth and followed through their NICU stay and up to 3 months of age with visits at 2 weeks, 4 weeks, and 3 months. Data collected include daily feeding logs, growth measurements such as length-for-age Z score at 3 months, illness events, and mortality. Safety and feeding progression are closely monitored, and infants discontinued if feeding targets are not met. The study assesses multiple growth and health outcomes to understand the impact of routine human milk fortification in this population.

LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk