Growth of Very Low Birth Weight Infants Who Received a Liquid Human Milk Fortifier: A Randomized, Controlled Multicenter Trial

Objectives: To evaluate growth (weight, length, head circumference, and knee-heel length [KHL]) in very low birth weight (VLBW) infants (500-1500 g) who received human milk with a liquid fortifier (LHMF) with high protein and fatty acid content versus a traditional powder fortifier (PHMF) for 45 days or until discharge.

Methods: This was a multicenter, randomized, controlled trial. An intention-to-treat analysis was performed to determine adverse events and withdrawal causes. We also performed an efficacy analysis involving the infants who completed at least 2 weeks of study.

Results: Of the 158 infants enrolled in the study, 146 completed at least 2 weeks, and 125 completed the entire study. The biodemographic characteristics were similar between groups, with no differences in increments of weight (22.9 vs 22.7 g kg-1 day-1), length (1.03 vs 1.09 cm/week), head circumference (0.91 vs 0.90 cm/week), or KHL (3.6 vs 3.3 mm/week). The KHL increment was greater in infants weighing >1 kg receiving LHMF (3.7 vs 3.2 mm/week, P = 0.027). Although there were no significant differences in serious adverse events, the incidence difference of the composite outcome death/necrotizing enterocolitis between groups warrants attention (1.3% with LHMF and 8.1% with PHMF).

Conclusion: There were no differences in the overall growth between VLBW infants receiving either fortifier.