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Randomized Controlled Trial Multicenter Study Comparative Study
Nutritional Support for Moderate-to-Late-Preterm Infants - A Randomized Trial.
- Tanith Alexander, Sharin Asadi, Michael Meyer, Jane E Harding, Yannan Jiang, Jane M Alsweiler, Mariana Muelbert, Frank H Bloomfield, and DIAMOND Trial Group.
- From Liggins Institute (T.A., S.A., J.E.H., M. Muelbert, F.H.B.), the Department of Statistics, Faculty of Science (Y.J.), and the Department of Paediatrics, Child and Youth Health (J.M.A.), University of Auckland, and the Neonatal Unit, Kidz First, Middlemore Hospital, Te Whatu Ora Counties Manukau (T.A., M. Meyer), Auckland, and Newborn Services, Starship Child Health, Te Toka Tumai Auckland, Te Whatu Ora (J.M.A.) - all in New Zealand.
- N. Engl. J. Med. 2024 Apr 25; 390 (16): 149315041493-1504.
BackgroundMost moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies for these infants is lacking.MethodsWe conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days' to 35 weeks 6 days' gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother's breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding).ResultsA total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P = 0.72) and among the infants who received milk supplement and those who received mother's breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P = 0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P = 0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant.ConclusionsThis trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother's breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.).Copyright © 2024 Massachusetts Medical Society.
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