一项单中心随机对照试验的初步研究：在新生儿重症监护病房中使用捐赠母乳对晚期早产儿和足月婴儿的影响。

A Pilot Single-Site Randomized Control Trial: Investigating the Use of Donor Milk in Late Preterm and Term Infants in the Neonatal Intensive Care Unit.

机构信息

Division of Neonatology and Developmental Biology, Department of Pediatrics, Neonatal Research Center of the University of California Los Angeles Children's Discovery and Innovation Institute, University of California Los Angeles, Los Angeles, California.

Department of Medicine, Statistics Core, University of California Los Angeles, Los Angeles, California.

出版信息

Am J Perinatol. 2024 May;41(S 01):e2427-e2435. doi: 10.1055/s-0043-1771261. Epub 2023 Aug 30.

DOI:10.1055/s-0043-1771261

PMID:37647913

Abstract

OBJECTIVE

We aimed to study donor milk (DM) supplementation when mother's own milk (MOM) was unavailable in term and late preterm infants (LPIs) admitted to the neonatal intensive care unit (NICU). We hypothesized that this study would be feasible, defined by the rate of consent, diet adherence, and study completion. We further hypothesized that compared with formula supplementation, DM supplementation, for no longer than 7 days from birth, would be associated with an increase in breastfeeding attempts and the percentage of MOM (MOM%) without adversely affecting growth. Breastfeeding attempts and MOM% were assessed over 48 hours at the end of the intervention, which was defined as NICU discharge or at the end of supplementation, whichever came sooner.

STUDY DESIGN

This was a pilot study ( = 32). Infants with a gestational age > 34 weeks admitted to the NICU were included. Infants were randomized to one of two groups: human milk (MOM + DM) or formula (MOM + F).

RESULTS

The consent rate was 52%. Adherence to the study diet was 97%, and completion was 100%. When the MOM + DM group was compared with the MOM + F group, there was no difference in breastfeeding attempts (median [interquartile range]: 3.5 [1.5-6] vs. 1.5 [0.5-4] times, = 0.1) or MOM% (60 vs. 59%, = 0.9). Weight and length at multiple time points were similar when the groups were compared.

CONCLUSION

A study randomizing term and LPIs in the NICU to DM or formula when MOM was unavailable is feasible. It remains unclear if DM improves breastfeeding success in this population.

KEY POINTS

· A study that randomizes term and late preterm infants in the NICU to DM or formula supplementation when mother's own milk is not available is feasible.. · It remains unclear if DM compared to formula supplementation improves direct breastfeeding.. · In general, growth was similar in infants who received DM or formula as a supplement..

摘要

目的

本研究旨在探讨在足月和晚期早产儿（LPIs）入住新生儿重症监护病房（NICU）时，当母亲的母乳（MOM）无法提供时，添加捐赠母乳（DM）的效果。我们假设该研究具有可行性，定义为同意率、饮食依从性和研究完成率。我们进一步假设，与配方奶补充相比，从出生起不超过 7 天的 DM 补充，将与增加母乳喂养尝试次数和 MOM 百分比（MOM%）相关，而不会对生长产生不利影响。在干预结束时（定义为 NICU 出院或补充结束，以较早者为准）的 48 小时内评估母乳喂养尝试次数和 MOM%。

研究设计

这是一项试点研究（n=32）。纳入胎龄>34 周且入住 NICU 的婴儿。将婴儿随机分为两组：人乳（MOM+DM）或配方奶（MOM+F）。

结果

同意率为 52%。对研究饮食的依从率为 97%，完成率为 100%。当 MOM+DM 组与 MOM+F 组进行比较时，母乳喂养尝试次数（中位数[四分位间距]：3.5[1.5-6] vs. 1.5[0.5-4]次，Z=0.1）或 MOM%（60% vs. 59%，Z=0.9）均无差异。比较两组时，多个时间点的体重和长度相似。