{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T16:52:14Z","timestamp":1781801534563,"version":"3.54.5"},"reference-count":44,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,5,2]],"date-time":"2023-05-02T00:00:00Z","timestamp":1682985600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>We aimed to compare the effects of nutrient-enriched formula with standard term formula on rate of body weight gain of late preterm infants appropriately grown for gestational age.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study design<\/jats:title><jats:p>A multi-center, randomized, controlled trial. Late preterm infants (34\u201337 weeks' gestation), with weight appropriate for gestational age (AGA), were randomized to nutrient enriched formula (NEF) with increased calories (22\u2005kcal\/30\u2005ml) from protein, added bovine milk fat globule membrane, vitamin D and butyrate or standard term formula 20\u2005kcal\/30\u2005ml (STF). Breastfed term infants were enrolled as an observational reference group (BFR). Primary outcome was rate of body weight gain from enrollment to 120 days corrected age (d\/CA). Planned sample size was 100 infants per group. Secondary outcomes included body composition, weight, head circumference and length gain, and medically confirmed adverse events to 365\u2005d\/CA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The trial was terminated early due to recruitment challenges and sample size was substantially reduced. 40 infants were randomized to NEF (<jats:italic>n<\/jats:italic>\u2009=\u200922) and STF (<jats:italic>n<\/jats:italic>\u2009=\u200918). 39 infants were enrolled in the BFR group. At 120\u2005d\/CA there was no evidence of a difference in weight gain between randomized groups (mean difference 1.77\u2005g\/day, 95% CI, \u22121.63 to 5.18, <jats:italic>P<\/jats:italic>\u2009=\u20090.31). Secondary outcomes showed a significant reduction in risk of infectious illness in the NEF group at 120\u2005d\/CA [relative risk 0.37 (95% CI, 0.16\u20130.85), <jats:italic>P\u2009<\/jats:italic>=\u20090.02].<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We saw no difference in rate of body weight gain between AGA late preterm infants fed NEF compared to STF. Results should be interpreted with caution due to small sample size.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>The Australia New Zealand Clinical Trials Registry (ACTRN 12618000092291). \u201cmailto:maria.makrides@sahmri.com\u201d <jats:email>maria.makrides@sahmri.com<\/jats:email>.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fped.2023.1146089","type":"journal-article","created":{"date-parts":[[2023,5,2]],"date-time":"2023-05-02T05:08:19Z","timestamp":1683004099000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":4,"title":["Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age\u2014A randomized controlled trial"],"prefix":"10.3389","volume":"11","author":[{"given":"Karen P.","family":"Best","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa 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