Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial

IF 6.9 1区医学 Q1 NUTRITION & DIETETICS American Journal of Clinical Nutrition Pub Date : 2025-05-01 DOI:10.1016/j.ajcnut.2025.02.019

Ariel A Salas, Emily Gunawan, Seabrook Jeffcoat, Kelly Nguyen

{"title":"Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial","authors":"Ariel A Salas, Emily Gunawan, Seabrook Jeffcoat, Kelly Nguyen","doi":"10.1016/j.ajcnut.2025.02.019","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>In preterm infants, the timing of human milk fortification when maternal or donor milk is offered at volumes of 60–80 mL/kg/d within the first 36 h after birth remains a matter of debate.</div></div><div><h3>Objectives</h3><div>This trial assessed the impact of early human milk fortification (<7 d postnatal age) on fat-free mass (FFM) <em>z</em>-scores.</div></div><div><h3>Methods</h3><div>This was an unmasked clinical trial involving preterm infants with birthweight <1800 g and gestational ages ranging from 29 0/7 to 33 6/7 weeks of gestation. Human milk-fed infants receiving feeding volumes of 60–80 mL/kg/d within the first 36 h after birth were randomly assigned to receive either early (between days 4 and 7) or delayed (between days 10 and 14) fortification using a bovine-derived fortifier. FFM was assessed at postnatal day 21 using air-displacement plethysmography.</div></div><div><h3>Results</h3><div>A total of 80 infants were randomly assigned. The mean birthweight was 1488 g (SD: 233). Baseline characteristics did not differ between groups. Of 80 infants randomly assigned shortly after birth, 74 had the primary outcome measured at ∼35 wk of postmenstrual age (interquartile range: 34–36). No statistically significant differences in FFM <em>z</em>-scores were observed between the 2 groups (−1.7 ± 0.9 compared with −1.8 ± 0.9; <em>P =</em> 0.64), but the early fortification group had higher weight [median difference: +131 g; 95% confidence interval (CI): 12, 236; <em>P =</em> 0.03], higher FFM (median difference: +103 g; 95% CI: 1, 193; <em>P =</em> 0.03), and higher length (mean difference: +0.9 cm; 95% CI: 0.1, 1.8; <em>P =</em> 0.04) at the time of body composition assessment.</div></div><div><h3>Conclusions</h3><div>In very preterm infants receiving early full enteral nutrition, providing early human milk fortification does not result in higher than usual FFM <em>z</em>-scores. This feeding strategy may, however, lead to a sustained increase in length, and transient increases in weight and FFM in grams.</div><div>This study was registered at clinicaltrials.gov as NCT05525585.</div></div>","PeriodicalId":50813,"journal":{"name":"American Journal of Clinical Nutrition","volume":"121 5","pages":"Pages 1117-1123"},"PeriodicalIF":6.9000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Clinical Nutrition","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002916525000875","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}

引用次数: 0

Abstract

Background

In preterm infants, the timing of human milk fortification when maternal or donor milk is offered at volumes of 60–80 mL/kg/d within the first 36 h after birth remains a matter of debate.

Objectives

This trial assessed the impact of early human milk fortification (<7 d postnatal age) on fat-free mass (FFM) z-scores.

Methods

This was an unmasked clinical trial involving preterm infants with birthweight <1800 g and gestational ages ranging from 29 0/7 to 33 6/7 weeks of gestation. Human milk-fed infants receiving feeding volumes of 60–80 mL/kg/d within the first 36 h after birth were randomly assigned to receive either early (between days 4 and 7) or delayed (between days 10 and 14) fortification using a bovine-derived fortifier. FFM was assessed at postnatal day 21 using air-displacement plethysmography.

Results

A total of 80 infants were randomly assigned. The mean birthweight was 1488 g (SD: 233). Baseline characteristics did not differ between groups. Of 80 infants randomly assigned shortly after birth, 74 had the primary outcome measured at ∼35 wk of postmenstrual age (interquartile range: 34–36). No statistically significant differences in FFM z-scores were observed between the 2 groups (−1.7 ± 0.9 compared with −1.8 ± 0.9; P = 0.64), but the early fortification group had higher weight [median difference: +131 g; 95% confidence interval (CI): 12, 236; P = 0.03], higher FFM (median difference: +103 g; 95% CI: 1, 193; P = 0.03), and higher length (mean difference: +0.9 cm; 95% CI: 0.1, 1.8; P = 0.04) at the time of body composition assessment.

Conclusions

In very preterm infants receiving early full enteral nutrition, providing early human milk fortification does not result in higher than usual FFM z-scores. This feeding strategy may, however, lead to a sustained increase in length, and transient increases in weight and FFM in grams.

This study was registered at clinicaltrials.gov as NCT05525585.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

早产儿使用强化牛奶进行早期全肠内营养：随机临床试验。

背景：在早产儿中，当母亲或供体在出生后的前36小时内以60-80 ml/kg/天的量提供母乳时，母乳强化的时机仍然是一个有争议的问题。目的：本试验评估早期母乳强化（出生后7天）对无脂质量（FFM） z评分的影响。方法：这是一项公开的临床试验，涉及出生体重< 1800 g，胎龄为29 0/7至33 6/7周的早产儿。在出生后的前36小时内，母乳喂养量为60-80毫升/公斤/天的婴儿被随机分为早期（第4天至第7天）或延迟（第10天至第14天）使用牛源性强化剂进行强化。在出生后第21天使用空气置换容积描记术评估FFM。结果：共有80名婴儿被随机化。平均出生体重1488 g （SD: 233）。各组间基线特征无差异。在80名出生后不久随机挑选的婴儿中，74名在月经后约35周时测量了主要结局（IQR: 34 - 36）。两组间FFM z-score差异无统计学意义(-1.7±0.9比-1.8±0.9；P =0.64)，但早期强化组体重更高(中位差：+131 g；95% ci: 12,236；p=0.03)， FFM较高(中位差：+103 g；95% ci: 1,193；P =0.03)，且长度更高(平均差值：+0.9 cm；95% ci: 0.1, 1.8；P =0.04)。结论：在接受早期全肠内营养的早产儿中，提供早期母乳强化并不会导致FFM z评分高于正常水平。然而，这种摄食策略可能导致体长持续增加，体重和饲料质量（以克计）短暂增加。临床试验注册：ClinicalTrials.gov: NCT05525585；https://clinicaltrials.gov/study/NCT05525585。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

American Journal of Clinical Nutrition 医学-营养学

CiteScore

12.40

自引率

4.20%

发文量

332

审稿时长

38 days

期刊介绍： American Journal of Clinical Nutrition is recognized as the most highly rated peer-reviewed, primary research journal in nutrition and dietetics.It focuses on publishing the latest research on various topics in nutrition, including but not limited to obesity, vitamins and minerals, nutrition and disease, and energy metabolism. Purpose: The purpose of AJCN is to: Publish original research studies relevant to human and clinical nutrition. Consider well-controlled clinical studies describing scientific mechanisms, efficacy, and safety of dietary interventions in the context of disease prevention or health benefits. Encourage public health and epidemiologic studies relevant to human nutrition. Promote innovative investigations of nutritional questions employing epigenetic, genomic, proteomic, and metabolomic approaches. Include solicited editorials, book reviews, solicited or unsolicited review articles, invited controversy position papers, and letters to the Editor related to prior AJCN articles. Peer Review Process: All submitted material with scientific content undergoes peer review by the Editors or their designees before acceptance for publication.