Rumbold Alice R, Lai Melissa M, August Deanne, Koorts Pieter, Donovan Tim, Yelland Lisa, Makrides Maria, Cuthbert Alana R, Klein Laura D, Ginis Teresa, Al Gharram Aya, Jones Susie, Summers Laura, McPhee Andrew, Keir Amy
Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Women and Babies Division, Women's and Children's Health Network, Adelaide, South Australia, Australia.
JAMA Pediatr. 2025 Aug 4. doi: 10.1001/jamapediatrics.2025.2365.
High-quality evidence supports the use of pasteurized donor human milk (donor milk) in very preterm infants with insufficient maternal milk available. However, evidence to guide the use of donor milk in more mature preterm infants is lacking.
To compare the effect of donor milk vs term infant formula, used to supplement insufficient maternal milk, on the time to establish full enteral feeds in moderate to late preterm infants.
DESIGN, SETTING, AND PARTICIPANTS: This multisite, blinded randomized clinical trial was conducted from July 6, 2021, to April 5, 2023, at 2 Australian neonatal units. Infants 4 days old or younger, born between 32 + 0 and 36 + 6 weeks' gestation, with a birth weight of 1500 g or higher, and admitted to a neonatal unit were eligible if they were clinically stable, ready to commence or had commenced enteral feeds, and had insufficient maternal milk available. Infants were followed up until 6-month corrected age (CA). Follow-up assessments until 6-month CA were completed by December 4, 2023, and data analyses were completed by January 23, 2025.
Infants were randomly assigned to receive supplemental donor milk or term formula for up to 8 days, stratified by site and gestational age at birth.
The primary outcome was time to full enteral feeds (defined as 150 mL/kg/day). Secondary outcomes included feed intolerance, growth, body composition, breast milk feeding, and hospital readmissions to 6-month CA.
Of 201 infants randomized (99 to donor milk, 102 to formula), the mean (SD) birth gestational age was 34.6 (1.2) weeks, mean (SD) birth weight was 2267.1 (450.8) g, 88 infants (43.8%) were female, and 75 infants (37.3%) were a twin or triplet. Mean (SD) time to reach full enteral feeds did not differ between groups (donor milk group: 5.7 [2.6] days; formula group: 5.8 [3.4] days; adjusted mean difference, -0.07; 95% CI, -0.90 to 0.76). Secondary outcomes were similar between groups, except that infants in the donor milk group had a lower rate of birth weight regain compared with the formula group (mean [SD] time to regain in donor milk group: 10.7 [5.7] days; formula group: 8.4 [4.4] days; hazard ratio, 0.65; 95% CI, 0.47-0.88).
In this multisite randomized clinical trial, supplemental donor milk did not reduce time to full enteral feeds in moderate to late preterm infants compared with term formula for up to 8 days.
anzctr.org.au Identifier: ACTRN12621000529842.
高质量证据支持在母亲乳汁不足的极早产儿中使用巴氏杀菌的捐赠人乳（捐赠母乳）。然而，缺乏指导在更成熟的早产儿中使用捐赠母乳的证据。
比较捐赠母乳与足月儿配方奶用于补充母亲不足的乳汁时，对中度至晚期早产儿建立完全肠内喂养时间的影响。
设计、地点和参与者：这项多中心、双盲随机临床试验于2021年7月6日至2023年4月5日在澳大利亚的2个新生儿病房进行。出生4天及以内、孕龄在32+0至36+6周之间、出生体重1500克及以上且入住新生儿病房的婴儿，如果临床稳定、准备开始或已开始肠内喂养且母亲乳汁不足，则符合入选标准。对婴儿进行随访至矫正年龄6个月。截至2023年12月4日完成了至矫正年龄6个月的随访评估，数据分析于2025年1月23日完成。
婴儿按出生地点和胎龄分层，随机分配接受补充捐赠母乳或足月儿配方奶，为期8天。
主要结局是完全肠内喂养的时间（定义为150毫升/千克/天）。次要结局包括喂养不耐受、生长、身体成分、母乳喂养及至矫正年龄6个月时的再次入院情况。
在随机分组的201名婴儿中（99名接受捐赠母乳，102名接受配方奶），平均（标准差）出生孕周为34.6（1.2）周，平均（标准差）出生体重为（450.8）克，88名婴儿（43.8%）为女性，75名婴儿（37.3%）为双胞胎或三胞胎。两组达到完全肠内喂养的平均（标准差）时间无差异（捐赠母乳组：5.7[2.6]天；配方奶组：5.8[3.4]天；调整后平均差异为-0.07；95%置信区间为-0.90至0.76）。除捐赠母乳组婴儿出生体重恢复率低于配方奶组外（捐赠母乳组恢复的平均[标准差]时间：10.7[5.7]天；配方奶组：8.4[4.4]天；风险比为0.65；95%置信区间为0.47-0.88），两组的次要结局相似。
在这项多中心随机临床试验中，与足月儿配方奶相比，补充捐赠母乳在长达8天的时间内并未缩短中度至晚期早产儿完全肠内喂养所需的时间。
anzctr.org.au标识符：ACTRN12621000529842
