Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial.

IF 3.2 Q1 PEDIATRICS

Clinical and Experimental Pediatrics Pub Date : 2025-01-01 Epub Date: 2024-10-31 DOI:10.3345/cep.2024.00591

Ameneh Lamsehchi, Maryam Shokouhi Solgi, Mohammad Kazem Sabzehei, Behnaz Basiri, Elahe Talebi Ghane, Kiana Kimiaei Asadi, Sina Azadnajafabad

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Abstract

Background: The oropharyngeal administration of colostrum (OAC) in neonates has several benefits.

Purpose: To investigate the short-term outcomes of OAC in preterm neonates.

Methods: We performed this 2-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021-2023. The intervention and control arms received 0.2 mL of their mother's colostrum or distilled water via oropharyngeal administration every 6 hours for 3 days starting from birth until 72 hours of age. The main study outcomes were neonatal death, the incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity (ROP), length of hospital stay, and period to full enteral feeding. A regression analysis was used to adjust for possible confounders.

Results: A total of 126 neonates (mean gestational age, 30.05 weeks) were randomized to the intervention and placebo groups (n=63 each) and had a mean±standard deviation weight of 1,247±193 g versus 1,156±215 g (P=0.013) and 1- and 5-min Apgar scores of 6.35 versus 5.38 (P=0.003) and 7.84 versus 7.13 (P=0.001), respectively. The mortality rate was 12.7% in the intervention group versus 14.3% in the placebo group (P=0.794). The necrotizing enterocolitis rate was significantly lower in the intervention versus placebo arm (11.1% vs. 28.6%, respectively, P=0.010), as was the clinically suspected sepsis rate (15.9% vs. 39.7%, respectively, P=0.004). The ROP and bronchopulmonary dysplasia rates did not differ significantly between groups after the adjustment for confounders. The mean length of hospital stay was shorter in the intervention group (26.1 days vs. 37.32 days, P=0.023). Moreover, the mean duration of antibiotic therapy and period to full feeding were significantly shorter in the intervention group.

Conclusion: OAC could effectively decrease the incidence of complications in preterm infants and facilitate earlier patient discharge.

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早产新生儿口咽初乳的短期疗效：双盲安慰剂对照随机试验。

背景：给新生儿口咽初乳（OAC）有多种益处：目的：研究早产新生儿口咽初乳（OAC）的短期疗效：我们于 2021-2023 年在伊朗的一家三级新生儿中心开展了这项双臂、双盲、安慰剂对照随机试验。干预组和对照组新生儿从出生到 72 小时内，每 6 小时口咽给药一次，连续 3 天，每次给药 0.2 毫升母亲初乳或蒸馏水。研究的主要结果是新生儿死亡、坏死性小肠结肠炎（NEC）发病率、败血症、早产儿视网膜病变（ROP）、住院时间和完全肠内喂养时间。采用回归分析法对可能的混杂因素进行了调整：共有126名新生儿（平均胎龄30.05周）被随机分配到干预组和安慰剂组（各63名），其平均体重（±SD）分别为1247±193克与1156±215克（P=0.013），1分钟和5分钟Apgar评分分别为6.35分与5.38分（P=0.003）和7.84分与7.13分（P=0.001）。干预组的死亡率为12.7%，安慰剂组为14.3%（P=0.794）。干预组与安慰剂组相比，NEC 发生率明显降低（分别为 11.1% 对 28.6%；P=0.010），临床疑似败血症发生率也明显降低（分别为 15.9% 对 39.7%；P=0.004）。在对混杂因素进行调整后，ROP 和支气管肺发育不良的发生率在组间没有显著差异。干预组的平均住院时间更短（26.1 对 37.32；P=0.023）。此外，干预组的平均抗生素治疗时间和完全进食时间也明显缩短：结论：OAC 可有效降低早产儿并发症的发生率，并有助于患者尽早出院。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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