NEOFORT Effect of Early Fortification on Growth Parameters at Discharge in Neonates less than 32weeks of Gestation A Randomized Controlled Trial.

This randomized controlled trial will evaluate the effect of early versus standard fortification on growth parameters in neonates <32 weeks gestation or <1500g birth weight. Conducted at Sri Ramachandra Medical College over two years, it will include preterm neonates receiving mother’s or donor human milk, excluding those with major congenital anomalies or surgical conditions. Group A will receive early fortification at 40 mL/kg/day, while Group B will receive standard fortification at 100 mL/kg/day. The primary outcome will be weight gain velocity at discharge, with secondary outcomes including time to regain birth weight, head circumference, linear growth velocity, feeding tolerance, NEC incidence, and time to full feeds. Using block randomization stratified by gestational age, 54 neonates per group will be required (power 80%, alpha 5%). Data will be analyzed using SPSS v26, employing descriptive statistics, Chi-square, and t-tests/Mann-Whitney tests, following an intention-to-treat approach. Ethical approval will be obtained, and parental consent will ensure confidentiality.