早产儿经口咽给予初乳的短期结局：一项双盲安慰剂对照随机试验
Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial.
作者信息
Lamsehchi Ameneh, Solgi Maryam Shokouhi, Sabzehei Mohammad Kazem, Basiri Behnaz, Ghane Elahe Talebi, Asadi Kiana Kimiaei, Azadnajafabad Sina
机构信息
Department of Neonatology, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.
Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
Clin Exp Pediatr. 2025 Jan;68(1):73-79. doi: 10.3345/cep.2024.00591. Epub 2024 Oct 31.
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.
背景
对新生儿进行口咽给予初乳（OAC）有诸多益处。
目的
探讨OAC对早产儿的短期结局。
方法
2021年至2023年，我们在伊朗一家三级新生儿中心开展了这项双臂、双盲、安慰剂对照的随机试验。干预组和对照组从出生至72小时龄，每6小时经口咽给予0.2 mL其母亲的初乳或蒸馏水，共3天。主要研究结局包括新生儿死亡、坏死性小肠结肠炎发病率、败血症、早产儿视网膜病变（ROP）、住院时间以及完全经口喂养时间。采用回归分析来调整可能的混杂因素。
结果
共有126例新生儿（平均胎龄30.05周）被随机分为干预组和安慰剂组（每组n = 63），干预组和安慰剂组的平均体重±标准差分别为1247±193 g和1156±215 g（P = 0.013），1分钟和5分钟阿氏评分分别为6.35和5.38（P = 0.003）以及7.84和7.13（P = 0.001）。干预组的死亡率为12.7%，安慰剂组为14.3%（P = 0.794）。干预组的坏死性小肠结肠炎发生率显著低于安慰剂组（分别为11.1%和28.6%，P = 0.010），临床疑似败血症发生率也是如此（分别为15.9%和39.7%，P = 0.004）。在调整混杂因素后，两组的ROP和支气管肺发育不良发生率无显著差异。干预组的平均住院时间较短（26.1天对37.32天，P = 0.023）。此外，干预组的抗生素治疗平均持续时间和完全喂养时间显著更短。
结论
OAC可有效降低早产儿并发症的发生率，并促进患者更早出院。
Zotero 插件