Effect of human milk enriched with human milk-based fortifier (HMBF) versus bovine milk-based fortifier (BMBF) on growth and morbidity among very low birth weight (VLBW) infants – A randomized controlled trial

Abstract

Introduction: Survival of preterm neonates increased dramatically with the advancement in neonatology services. These infants have high nutritional demands for optimal growth, and human milk alone is insufficient to meet their needs. Hence, fortification of milk has become the standard of care. Bovine milk-based fortifiers (BMBF) are commonly used, but there exists concern regarding the exposure to cow milk protein. Human milk-based fortifier (HMBF) use offers a theoretical advantage from the immunological and gastrointestinal standpoint. We intend to study the effects of HMBF compared to BMBF on growth and morbidity of preterm neonates. Methodology: It is a single-centre, open-labelled, randomized controlled trial (RCT) enrolling very low birth weight (VLBW) neonates of less than 34 weeks of gestation weighing between 1,000 and 1,500 g. Only human milk was used, and infants were randomized to receive either fortifier after reaching 100 ml/kg/day of enteral feeds. Growth and morbidity of preterm neonates were analysed. Results: A total of 50 infants were enrolled (25 in each arm). Weight gain (21.42 vs. 20.84 g/day, p = 0.77) and growth velocity (16.45 vs. 15.85 g/kg/day, p = 0.57) were similar in both groups with no statistical difference. Sepsis (relative risk [RR] = 0.6), feed intolerance (RR = 0.57), necrotizing enterocolitis (NEC) (RR = 0.33) and duration of hospital stay (33 vs. 36 days) were better in the HMBF group than in the BMBF group. Conclusion: Growth velocity was similar in both groups. However, HMBF was well tolerated by neonates with lesser incidence of feed intolerance, NEC, sepsis, and lesser hospital stay duration than in neonates supplemented with BMBF. Given the fewer number of studies, there is a need for well-powered RCTs with a good sample size to fill the knowledge gap.