Biochemical and Clinical Outcomes of Human Milk Fortification in Preterm Infants: A Randomised Controlled Study from a Tertiary NICU

Abstract

Background: Preterm neonates are vulnerable to protein-energy malnutrition and
metabolic complications due to immature physiology and increased nutritional
demands. While human milk fortification is known to improve growth, its impact on
biochemical markers and clinical safety outcomes remains inadequately explored in
Indian NICU settings.
Objective: To evaluate the effects of multinutrient human milk fortification on
biochemical markers (Blood Urea Nitrogen [BUN], serum albumin) and clinical
outcomes such as feed intolerance, necrotizing enterocolitis (NEC), and duration of
hospital stay in preterm neonates.
Methods: A randomized controlled trial was conducted on 72 preterm infants (<37
weeks, <2kg) allocated to a fortified milk group (FG) or unfortified group (UFG).
Weekly BUN and serum albumin levels were measured until discharge. Adverse
events and duration of hospitalization were also recorded.
Results: The FG demonstrated significantly higher serum albumin levels (3.5 ± 0.3
g/dL vs. 3.0 ± 0.4 g/dL, p<0.01) and optimal BUN profiles. Incidence of feed
intolerance and NEC were low and comparable across groups. Median hospital stay
was shorter in FG (21 vs. 26 days, p<0.05).
Conclusion: Fortification of breast milk in preterm neonates is biochemically
beneficial and clinically safe, supporting its integration in routine NICU protocols.