Osteoporos Int DOI 10.1007/s00198-015-3144-8

ORIGINAL ARTICLE

Supplemented vs. unsupplemented human milk on bone mineralization in very low birth weight preterm infants: a randomized clinical trial P. R. Einloft 1,2 & P. C. R. Garcia 1,2,3 & J. P. Piva 4,5 & R. Schneider 1,6 & H. H. Fiori 1,7 & R. M. Fiori 1,7

Received: 19 August 2014 / Accepted: 20 April 2015 # International Osteoporosis Foundation and National Osteoporosis Foundation 2015

Abstract Summary 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 * P. C. R. Garcia [email protected] 1

Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil

2

Pediatric Intensive Care, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil

3

Rua Curupaiti, 62, 90820-090 Porto Alegre, RS, Brazil

4

Pediatric Intensive Care, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil

5

Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil

6

Institute of Geriatrics and Gerontology, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil

7

Neonatal Intensive Care Unit, Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS, Brazil

were randomly assigned to the intervention group (n=19) to receive human milk supplemented with FM 85® or to a cont r o l g r o u p ( n = 1 9 ) t o r e c e i v e h u m a n m il k o n l y. 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. Keywords Bone densitometry in preterm newborns . Bone mineralization in preterm newborns . Human milk . Human milk supplementation . Very low birth weight newborns

Introduction In preterm birth, newborn infants miss the period of greatest mineral accretion. As a result, they may develop from hypomineralization to severe metabolic bone disease [1]. Several studies have shown that preterm newborns fed human milk (HM) exclusively failed to attain the same level of intrauterine bone mineralization [2–5], even when feeding with

Osteoporos Int

human breast milk was initiated early [5]. Bone mineral disease has been described in about 50 % of preterm newborns with birth weight below 1000 g and about 30 % of those below 1500 g [6]. Small, linear fractures, which may go unnoticed [5, 7], may occur in up to 40 % of newborns with very low birth weight (VLBW) fed exclusively on HM. Studies suggest that HM is advantageous for preterm infants in terms of digestibility, protection against infections, decreased incidence of necrotizing enterocolitis, and better school performance compared to preterm formula [8, 9]. The American Academy of Pediatrics recommends HM as the preferred food for all infants, both term as well as preterm [10]. A number of studies have suggested that supplementation of HM with protein, calcium, and phosphorus improves bone mineralization, reducing the risk of osteopenia and metabolic bone disease [2–4, 10–14]. In other studies, however, this was not observed. In a meta-analysis, a clear effect of these supplements on bone mineral content (BMC) was not found [15]. Likewise, in general, significant changes in serum calcium and phosphorus and urinary calcium and phosphorus have not been found following supplementation. However, it is well known that alkaline phosphatase (ALP) activity is more correlated with the diagnosis of bone demineralization than with the serum calcium and phosphorus [16–19]. Introduced in 1987 as a diagnostic tool for use in adults, bone densitometry (DXA) has come to be considered the “gold standard” for the diagnosis of osteopenia and deficient bone mineralization in preterm newborns with VLBW [2, 17, 18]. The current trial was therefore set up to compare, in a group of VLBW preterm newborns, supplemented vs. unsupplemented HM with regard to bone mineralization measured by whole-body DXA and calcium/phosphorus metabolism. We tested the hypothesis that administration of HM supplemented with a multinutrient formula would improve bone mineralization in VLBW preterm newborns.

Materials and methods This prospective, randomized (1:1 for two groups), comparator-controlled, parallel-group, single-center trial was conducted at a university hospital (Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul [PUCRS]) in Porto Alegre, southern Brazil, from July 2006 to January 2010. Porto Alegre is the capital of Rio Grande do Sul, the southernmost state of Brazil. Eligible participants were all VLBW preterm newborns (900 IU/L had BMC below the 5th percentile when compared to a control group [30]. In the present study, we found that five children had ALP >900 IU/L. All were in the group that received HM without FM 85®. A recent review by Cohen et al. addressed the issue of whether a higher amount of calcium and phosphorus would have the ability to improve bone mineralization in preterm newborns. They suggest that improvement in bone mineralization would most probably be related to the volume of HM ingested [26]. FM 85® has been previously used in preterm newborns weighing

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

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 simi...
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