Supplemented vs. unsupplemented human milk on bone mineralization in very low birth weight preterm infants: a randomized clinical trial

Abstract

Very low birth weight preterm newborns weighing less than 1500 g were randomized to receive human milk supplemented with FM 85® or not. They have similar bone mineral content (BMC) at baseline, but, at the end of study, BMC was increasingly higher in the FM 85® group.

Introduction: The purpose of this study is to evaluate the effectiveness of a human milk supplement (FM 85®; Nestlé, Vevey, Switzerland) developed for the purpose of improving nutrition, including bone mineralization, in very low birth weight preterm newborns.

Methods: Preterm infants weighing less than 1500 g at birth admitted to the neonatal intensive care unit of a university hospital were studied. During hospitalization, they were fed at least 50 % of human milk. Newborns with ≥20 days of age were randomly assigned to the intervention group (n = 19) to receive human milk supplemented with FM 85® or to a control group (n = 19) to receive human milk only. Anthropometric measurements, whole-body bone densitometry (DXA), and biochemical tests were performed at study entry and at the end of the study (shortly before discharge when the infant had reached 2000 g).

Results: There were no start- or end-of-study differences between the two groups, except for daily increase in length (p = 0.010). At baseline, both groups had similar BMC: 5.49 ± 3.65 vs. 4.34 ± 2.98 g (p = 0.39) for the intervention and control group, respectively. However, at the end of the study, BMC was higher in the intervention group: 10.3 ± 4.71 vs. 6.19 ± 3.23 g (p = 0.003). The mean increase in BMC during the observation period was 4.90 ± 4.46 g for the intervention group and 1.86 ± 3.17 g for the control group (p = 0.020). Serum alkaline phosphatase levels were higher in the control group (720 ± 465 vs. 391 ± 177 IU/L; p = 0.007).

Conclusions: Our data suggest that supplementation of human milk with FM 85® leads to improved bone mineralization in very low birth weight preterm newborns.