A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder versus unfortified human milk on the growth of preterm very low birth weight infants.

To optimize growth in very low birth weight (VLBW) infants, human milk fortification is standard of care in neonatal units of high-income countries. However, commercial fortifiers may not be available or it may be too expensive in resource-limited settings. As an alternative to using human milk fortifiers, we studied the effects of milk fortification with an infant formula on growth and biochemical parameters of very low birth weight (VLBW) infants We undertook a prospective, randomized controlled trial in the neonatal unit of a tertiary care hospital in South India. Preterm infants weighing <1500 grams and <34 weeks of gestation were randomized after stratification according to birth weight into two groups (<1250 g and 1250 to <1500 g). One group received fortified human milk while the other received exclusive human milk. The fortification was done with a commercially available infant milk powder added to expressed breast milk (when the infant reached 150 ml/kg/day of feeds) and continued till the infant reached 1800 g. The primary outcome was the rate of weight gain/kg/day. Secondary outcome measures were linear growth, head circumference increase, biochemical parameters to assess the adequacy or excess of protein supplementation and comorbidities like feed intolerance, sepsis, and necrotizing enterocolitis (NEC). Total of 163 babies were randomized during the study period, of whom 148 babies (73 in the standard arm and 75 in the fortification arm) completed the trial. Baseline demographic data among the two groups were comparable. Weight gain/kg/day (mean difference (MD) 1.98 g/kg/day; 95% CI: 1.03-2.92; <.001) and linear growth (MD 0.09 cm/week; 95% CI: 0.02-0.2; =.02) was significantly higher in the fortification arm as compared to the control arm. The head growth (head circumference gain in cm/week) was higher and length of hospital stay lesser in the fortification arm, though not statistically significant. Biochemical parameters, rates of sepsis, feed intolerance, and necrotizing enterocolitis (NEC) were not different between the two groups. Fortification with Infant milk powder achieves better growth parameters than unfortified human milk and can be a useful alternative for feeding preterm VLBW infants in low resource settings.