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经口给予初乳是否能降低极早产儿的发病率和死亡率?一项随机平行组对照试验。

Does oropharyngeal administration of colostrum reduce morbidity and mortality in very preterm infants? A randomised parallel-group controlled trial.

机构信息

Department of Neonatology, Apollo Cradle, Gurgaon, India.

Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.

出版信息

J Paediatr Child Health. 2021 Sep;57(9):1467-1472. doi: 10.1111/jpc.15529. Epub 2021 Apr 28.

Abstract

AIM

To evaluate whether a strategy of oropharyngeal administration of colostrum reduces morbidity and mortality in very preterm infants.

METHODS

A total of 260 neonates with gestational age 26-31 weeks at birth were randomised between August 2017 and August 2018 to receive 0.2 mL of human milk or placebo respectively via the oropharyngeal route, beginning within 24 h after birth, and continued every 3 h until oral feeds were initiated. The primary outcome was a composite of death, late-onset sepsis (LOS) or necrotising enterocolitis (NEC) in the neonatal period.

RESULTS

A total of 260 infants (mean gestational age 29.5 weeks, and mean birthweight 1201.7 g) were included in the primary analysis. The composite primary outcome occurred in 43 (33.6%) infants in the colostrum group and 38 infants (29.7%) in the placebo group, and the difference was not statistically significant (P = 0.50). Secondary outcomes including the incidence of death, NEC, LOS, probable sepsis, intraventricular haemorrhage, ventilator-associated pneumonia, retinopathy of prematurity, bronchopulmonary dysplasia, time to full feeds, time to regain birthweight, duration of hospital stay and survival to 6 months without major neurosensory impairment were also comparable between the two groups.

CONCLUSION

A strategy of oropharyngeal administration of colostrum in very preterm and extremely preterm neonates did not decrease the composite primary outcome of death, LOS or NEC. This finding is consistent with most published literature in the area.

摘要

目的

评估经口给予初乳是否能降低极早产儿的发病率和死亡率。

方法

2017 年 8 月至 2018 年 8 月期间,共纳入 260 例胎龄 26-31 周的新生儿,随机分为经口给予 0.2 mL 人乳或安慰剂组,分别于出生后 24 h 内开始,每 3 h 一次,直至开始口服喂养。主要结局为新生儿期死亡、晚发型败血症(late-onset sepsis,LOS)或坏死性小肠结肠炎(necrotising enterocolitis,NEC)的复合结局。

结果

共 260 例婴儿(平均胎龄 29.5 周,平均出生体重 1201.7 g)纳入主要分析。初乳组复合主要结局 43 例(33.6%),安慰剂组 38 例(29.7%),差异无统计学意义(P=0.50)。次要结局,包括死亡率、NEC、LOS、疑似败血症、颅内出血、呼吸机相关性肺炎、早产儿视网膜病变、支气管肺发育不良、达到全肠喂养的时间、恢复出生体重的时间、住院时间和 6 个月时无重大神经感觉损害的存活率,两组间也无显著差异。

结论

极早产儿和超低出生体重儿经口给予初乳并未降低死亡、LOS 或 NEC 的复合主要结局。这一发现与该领域的大多数已发表文献一致。

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