牛初乳预防极低出生体重儿坏死性小肠结肠炎和败血症的随机双盲安慰剂对照试验
Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates: A Randomized, Double-blind, Placebo-controlled Pilot Trial.
作者信息
Balachandran Binesh, Dutta Sourabh, Singh Ramandeep, Prasad Rajendra, Kumar Praveen
机构信息
Neonatal Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Neonatal Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India
出版信息
J Trop Pediatr. 2017 Feb;63(1):10-17. doi: 10.1093/tropej/fmw029. Epub 2016 Jun 9.
OBJECTIVE
To study the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants.
STUDY DESIGN
Randomized, double-blind, placebo-controlled pilot trial.
PARTICIPANTS
Neonates with birth weight ≤1500 g, gestation ≤32 weeks and postnatal age ≤96 h.
INTERVENTION
Enteral bovine colostrum or placebo, four times a day, till 21 days of life or discharge or death.
MAIN OUTCOME MEASURES
Definite NEC. Secondary outcomes included sepsis, mortality and stool interleukin-6 (IL-6) levels.
RESULTS
Of the total 86 subjects (43 in each group), there were no statistically significant in the main outcome measures. In the colostrum group, there were trends toward higher stool IL-6 values and higher incidence of ileus and radiological signs of NEC.
CONCLUSION
The use of prophylactic enteral bovine colostrum in VLBW infants shows a trend toward increased stool IL-6 and features of NEC. We were unable to detect clinical benefits.
目的
研究牛初乳对预防极低出生体重（VLBW）婴儿坏死性小肠结肠炎（NEC）和败血症的疗效。
研究设计
随机、双盲、安慰剂对照试验。
研究对象
出生体重≤1500g、胎龄≤32周且出生后年龄≤96小时的新生儿。
干预措施
肠内给予牛初乳或安慰剂，每日4次，直至出生后21天或出院或死亡。
主要观察指标
确诊的NEC。次要指标包括败血症、死亡率和粪便白细胞介素-6（IL-6）水平。
结果
在总共86名受试者（每组43名）中，主要观察指标无统计学显著差异。在初乳组中，粪便IL-6值较高、肠梗阻发生率较高以及出现NEC放射学征象的趋势更为明显。
结论
在VLBW婴儿中预防性使用肠内牛初乳有使粪便IL-6升高及出现NEC特征的趋势。我们未能检测到临床益处。
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