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临床试验/JPRN-UMIN000002543
JPRN-UMIN000002543已完成未知

Effect of bifidbacterium bifidum supplementation on morbidity of very low birth weight infants - bifidbacterium supplementation for very low birth weight infants

Maternal and Perinatal Center, Tokyo Women's Medical University0 个研究点目标入组 400 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
400

研究概览

简要总结

A total of 291 VLBW infants were enrolled in the study, B group (n = 160) and P group (n = 131). Among them, 233 infants were established enteral feeding within 21 days after birth, and were received B.bifidum or Placebo until their body weight reached 2000g (119 and 114 infant respectively). There was a significant difference in the establishment of enteral feeding which was 11.0+-3.6 days in B group and 12.1+-3.8 days in P group, respectively (p<0.05). The growth of the infants during the stay in NICU was not different between the groups. However, the incidence of sepsis among all enrolled infants was significantly lower in B group (p<0.05). There was no difference in the incidence of other adverse outcomes. B.bifidum administration to VLBW infants accelerated their enteral feeding after birth without increasing of adverse effects.

研究设计

研究类型
Interventional

入排标准

年龄范围
ot applicable 至 0weeks-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • severe bacterila infection congenital anomaly not suitabel for the trial defined by the attending neonatologist

研究者

发起方
Maternal and Perinatal Center, Tokyo Women&#39;s Medical University

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