Feed fortification for enteral nutrition in low birth weight infants-LBW Formula vs HMF- An RCT

Introduction: Premature delivery and intrauterine growth restriction results in decreased nutrition deposition in infant. Fortification of expressed breast milk with Human Milk Fortifier (HMF) or Low Birth Weight(LBW) powder increases the nutrient content of milk without compromising its other beneficial effects. Materials and Method: A randomized control study was undertaken to compare efficacy of the fortification of HMF vs LBW formula in breast milk feeds of babies who were hospitalized and weighed less than 2kg. The time to regain birth weight was considered the primary outcome. Secondary outcomes analysed were feed intolerance as evidenced by increased pre-feed residues, vomiting, abdominal distension and NEC. Results: Total 96 babies were included in the study(46 HMF group & 46 LBW group). The time to regain birth weight was 6.09+/- 1.834 in HMF group and 7.32+/-2.69 in LBW group(p=0.39) which was comparable between the two groups except in the term babies in the HMF group who regained birth weight significantly faster than the LBW formula group(p=0.05). The secondary outcomes of feed intolerance viz. prefeed residue, abdominal distension and necrotizing enterocolitis occurred more frequently in LBW group as compared to HMF group, but the result was statistically not significant. However, incidence of vomiting was significantly more in LBW group(p=0.03). The average cost of fortification per patient was more in HMF group(262 INR) as compared to LBW group(10.2 INR) and the difference was highly statistically significant (p<0.0001). Conclusion: The fortification of breast milk with human milk fortifier is as efficacious as low birth weight formula. Both the fortificants were equally well tolerated except for vomiting which occurred more with LBW formula fortification. The cost of treatment with LBW formula fortification was considerably cheaper than the HMF group. We therefore recommend LBW formula fortification of breast milk in low birth weight infants for quicker weight gain in the low resource setting.