期刊
JAMA PEDIATRICS
卷 175, 期 8, 页码 790-796出版社
AMER MEDICAL ASSOC
DOI: 10.1001/jamapediatrics.2021.0678
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This study compared fortification of expressed breast milk using preterm formula powder and human milk fortifier in very low birth weight neonates. The results showed that fortification with preterm formula powder was not inferior to fortification with human milk fortifiers in terms of weight gain, and had lower incidence of feed intolerance.
This randomized clinical trial investigates whether fortification of expressed breast milk by preterm formula powder is noninferior to fortification by human milk fortifier, in terms of short-term weight gain, in very low-birth-weight neonates Importance Fortification of expressed breast milk (EBM) using commercially available human milk fortifiers (HMF) increases short-term weight and length in preterm very low-birth-weight (VLBW) neonates. However, the high cost and increased risk of feed intolerance limit their widespread use. Preterm formula powder fortification (PTF) might be a better alternative in resource-limited settings. Objective To demonstrate that fortification of EBM by preterm formula powder is noninferior to fortification by HMF, in terms of short-term weight gain, in VLBW neonates. Design, Setting, and Participants Open-label, noninferiority, randomized trial conducted from December 2017 to June 2019 at a level 3 neonatal unit in India. The trial enrolled preterm (born at or before 34 weeks of gestation) VLBW neonates receiving at least 100 mL/kg/d of feeds and consuming 75% of milk or more as EBM. Interventions Neonates were randomly assigned to receive fortification by either PTF or HMF. Calcium, phosphorus, iron, vitamin D, and multivitamins were supplemented in PTF and only vitamin D in the HMF group to meet the recommended dietary allowances. Main Outcomes and Measures The primary outcome was the weight gain until discharge from the hospital or 40 weeks' postmenstrual age, whichever was earlier; the prespecified noninferiority margin was 2 g/kg/d. Secondary outcomes included morbidities such as necrotizing enterocolitis, feed intolerance, and extrauterine growth restriction (<10th percentile on the Fenton chart at 40 weeks' postmenstrual age). Results Of the 123 neonates enrolled, 60 and 63 were randomized to the PTF and HMF groups, respectively. The mean gestation (30.5 vs 29.9 weeks) and birth weight (1161 vs 1119 g) were comparable between the groups. There was no difference in the mean (SD) weight gain between the PTF and HMF groups (15.7 [3.9] vs 16.3 [4.0] g/kg/d; mean difference, -0.5 g/kg/d; 95% CI, -1.9 to 0.7). The lower bound of 95% CI did not cross the noninferiority margin. The incidence of feed intolerance was lower in the PTF group (1.4 vs 6.8 per 1000 patient-days; incidence rate ratio 0.19; 95% CI, 0.04 to 0.95), and fewer neonates required withholding of fortification for 24 hours or more (5% vs 22%; risk ratio, 0.22; 95% CI, 0.07 to 0.75). The incidence of necrotizing enterocolitis stage II or more (0 vs 5%) and extrauterine growth restriction (73% vs 81%) was comparable between the groups. Conclusions and Relevance Fortification with preterm formula powder is not inferior to fortification with human milk fortifiers in preterm neonates. Given the possible reduction in feed intolerance and lower costs, preterm formula might be a better option for fortification, especially in resource-restricted settings. Question Is fortification of expressed breast milk by preterm formula powder noninferior, in terms of weight gain, to fortification by a commercially available human milk fortifier? Findings In this noninferiority trial enrolling 123 neonates at less than 34 weeks of gestation, the mean weight gain in the preterm formula group was 15.7 g/kg/d and in the human milk fortifier group was 16.3 g/kg/d. The difference was not significant and did not reach the prespecified noninferiority margin, and the incidence of feed intolerance was significantly lower in the preterm formula group. Meaning Preterm formula powder might be a better alternative for breast milk fortification in resource-constrained settings.
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