Most premature and very low birthweight infants cannot tolerate breast milk feeding in the first few days of life and are deprived of its benefits. This study evaluates the clinical outcomes of administering breast milk cell fractions to neonates with a birthweight of ≤1800 g. We conducted a randomized controlled trial on 156 infants in the neonatal intensive care unit of Mahdieh Maternity Hospital in Tehran, Iran, from May 2019 to April 2020. All neonates with a birthweight ≤1800 g were enrolled and divided into intervention and control groups using stratified block randomization. Neonates in the intervention group received the extracted breast milk cell fractions (BMCFs) of their own mother’s milk after being centrifuged in the first 6 to 12 h after birth. The control group received routine care, and breastfeeding was started as soon as tolerated in both groups. Study outcomes were necrotizing enterocolitis (NEC), death, and in-hospital complications. We divided participants into two groups: 75 neonates in the intervention group and 81 neonates in the control group. The mean birthweight of neonates was 1390.1 ± 314.4 g, and 19 (12.2%) neonates deceased during their in-hospital stay. The incidence of NEC was similar in both groups. After adjustment for possible confounders in the multivariable model, receiving BMCFs were independently associated with lower in-hospital mortality (5 [26.3%] vs. 70 (51.1%]; odds ratio (OR): 0.24; 95% confidence interval [CI] 0.07, 0.86). Also, in a subgroup analysis of neonates with birthweight less than 1500 g, in-hospital mortality was significantly lower in the intervention group (4 [9.5%] vs. 13 [30.2%]; OR: 0.24; 95% CI 0.07, 0.82). There were no differences in major complications such as bronchopulmonary dysplasia and retinopathy of prematurity between the two groups. No adverse effects occurred. Our research demonstrated a significantly lower mortality rate in neonates (with a birthweight of ≤1800 g) who received breast milk cell fractions on the first day of life. Since this is a novel method with minimal intervention, we are looking forward to developing and evaluating this method in larger studies. IIranian Registry of Clinical Trials. Registered 25 May 2019, IRCT20190228042868N1 .

中文翻译：

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对出生体重等于或小于 1800 g 的新生儿给予母乳细胞组分：一项随机对照试验

大多数早产儿和极低出生体重婴儿在生命的最初几天无法忍受母乳喂养，并被剥夺了母乳的益处。本研究评估了对出生体重≤1800 g 的新生儿给予母乳细胞组分的临床结果。我们于 2019 年 5 月至 2020 年 4 月在伊朗德黑兰 Mahdieh 妇产医院的新生儿重症监护病房对 156 名婴儿进行了随机对照试验。所有出生体重≤1800 g 的新生儿均入组，并采用分层方法分为干预组和对照组块随机化。干预组的新生儿在出生后的最初 6 至 12 小时内接受离心后从自己的母乳中提取的母乳细胞组分（BMCFs）。对照组接受常规护理，两组均在耐受后立即开始母乳喂养。研究结果是坏死性小肠结肠炎 (NEC)、死亡和院内并发症。我们将参与者分为两组：干预组 75 名新生儿和对照组 81 名新生儿。新生儿的平均出生体重为 1390.1 ± 314.4 g，19 名（12.2%）新生儿在住院期间死亡。两组的NEC发生率相似。在对多变量模型中可能的混杂因素进行调整后，接受 BMCF 与较低的住院死亡率独立相关（5 [26.3%] vs. 70 (51.1%]；优势比 (OR)：0.24；95% 置信区间 [CI] 0.07, 0.86). 此外，在对出生体重小于 1500 g 新生儿的亚组分析中，干预组的住院死亡率显着降低（4 [9.5%] vs. 13 [30.2%]；或：0.24；95% CI 0.07, 0.82)。两组间支气管肺发育不良、早产儿视网膜病变等主要并发症无差异。没有发生不良反应。我们的研究表明，在出生第一天接受母乳细胞组分的新生儿（出生体重≤1800 克）的死亡率显着降低。由于这是一种干预最少的新方法，我们期待在更大的研究中开发和评估这种方法。IIranian 临床试验注册中心。2019 年 5 月 25 日注册，IRCT20190228042868N1。我们的研究表明，在出生第一天接受母乳细胞组分的新生儿（出生体重≤1800 克）的死亡率显着降低。由于这是一种干预最少的新方法，我们期待在更大的研究中开发和评估这种方法。IIranian 临床试验注册中心。2019 年 5 月 25 日注册，IRCT20190228042868N1。我们的研究表明，在出生第一天接受母乳细胞组分的新生儿（出生体重≤1800 克）的死亡率显着降低。由于这是一种干预最少的新方法，我们期待在更大的研究中开发和评估这种方法。IIranian 临床试验注册中心。2019 年 5 月 25 日注册，IRCT20190228042868N1。