Clinical Research Centre, The International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
MOE-Shanghai Key Laboratory of Children's Environmental Health, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
JAMA Netw Open. 2024 Apr 1;7(4):e247145. doi: 10.1001/jamanetworkopen.2024.7145.
Delayed meconium evacuation and delayed achievement of full enteral feeding among premature infants are associated with poor short- and long-term outcomes. Identifying a more effective and safer enema for meconium evacuation is imperative for improving neonatal care.
To examine whether breast milk enemas can shorten the time to complete meconium evacuation and achievement of full enteral feeding for preterm infants.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, open-label, parallel-group, single-center clinical trial was conducted from September 1, 2019, to September 30, 2022, among 286 preterm infants with a gestational age of 23 to 30 weeks in the neonatal ward of the Shengjing Hospital of China Medical University in Shenyang.
Preterm infants were randomly assigned to receive either breast milk enemas or normal saline enemas 48 hours after birth.
The primary outcomes were time to complete meconium evacuation and time to achieve full enteral feeding. Secondary outcomes were duration of hospitalization, weight at discharge, and duration of total parenteral nutrition. Intention-to-treat and per-protocol analyses were conducted.
In total, 286 preterm infants (mean [SD] gestational age, 198.8 [7.9] days; 166 boys [58.0%]) were eligible and included in this study. A total of 145 infants were randomized to the normal saline group, and 141 were randomized to the breast milk group. The time to achieve complete meconium evacuation was significantly shorter in the breast milk group than in the normal saline group (-2.2 days; 95% CI, -3.2 to -1.2 days). The time to achieve full enteral feeding was also significantly shorter in the breast milk group than in the normal saline group (-4.6 days; 95% CI, -8.0 to -1.2 days). The duration of total parenteral nutrition was significantly shorter in the breast milk group than in the normal saline group (-4.6 days; 95% CI, -8.6 to -1.0 days). There were no clinically notable differences in any other secondary or safety outcomes between the 2 groups.
In this randomized clinical trial testing the effects of breast milk enema on meconium evacuation, breast milk reduced the time to achieve complete meconium evacuation and achieve full enteral feeding for preterm infants with a gestational age of 23 to 30 weeks. Subgroup analyses highlight the need for tailored interventions based on gestational age considerations.
isrctn.org Identifier: ISRCTN17847514.
早产儿胎便排出延迟和完全肠内喂养的延迟与短期和长期结局较差有关。为了改善新生儿护理，迫切需要找到一种更有效和更安全的灌肠方法来促进胎便的排出。
研究母乳灌肠是否可以缩短早产儿胎便完全排出和实现完全肠内喂养的时间。
设计、地点和参与者：这是一项随机、开放标签、平行组、单中心临床试验，于 2019 年 9 月 1 日至 2022 年 9 月 30 日在中国医科大学盛京医院新生儿病房进行，共纳入 286 名胎龄为 23 至 30 周的早产儿。
早产儿在出生后 48 小时随机接受母乳灌肠或生理盐水灌肠。
主要结局为胎便完全排出时间和完全肠内喂养时间。次要结局为住院时间、出院时体重和全胃肠外营养时间。进行了意向治疗和方案分析。
共有 286 名早产儿（平均[标准差]胎龄 198.8[7.9]天；男婴 166 名[58.0%]）符合条件并纳入本研究。共有 145 名早产儿被随机分配到生理盐水组，141 名早产儿被随机分配到母乳组。母乳组胎便完全排出时间明显短于生理盐水组（-2.2 天；95%置信区间，-3.2 至-1.2 天）。母乳组完全肠内喂养时间也明显短于生理盐水组（-4.6 天；95%置信区间，-8.0 至-1.2 天）。母乳组全胃肠外营养时间明显短于生理盐水组（-4.6 天；95%置信区间，-8.6 至-1.0 天）。两组在任何其他次要结局或安全性结局方面均无明显差异。
在这项测试母乳灌肠对胎便排出影响的随机临床试验中，母乳可缩短胎龄为 23 至 30 周的早产儿胎便完全排出和完全肠内喂养的时间。亚组分析强调需要根据胎龄考虑制定个性化干预措施。
isrctn.org 标识符：ISRCTN80335142。
