跳至主要内容
临床试验/EUCTR2008-001324-31-IT
EUCTR2008-001324-31-IT进行中(未招募)不适用

Efficacy and security of oral supplementation with a probiotic (Lactobacillus reuteri) in newborns with birth weight < 1500 g: effects on necrotising enterocolitis (NEC) and gut colonization with gram negative bacteria. - NEO 2008-01

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2008年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1)birth weight < 1500 gr (VLBW infants)
  • 2)infants from 1 to 4 days-old
  • 3)written informed consent signed by each infant?s parents
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • EXCLUSION CRITERIA :
  • 1)anatomic gastrointestinal malformations
  • 2)major congenital malformations
  • 3)severe clinical conditions that, according to the researcher judgement, do not indicate the inclusion in the study
  • 4)patients unable to follow the study protocol and to sign written informed consent. The consent must be signed also by parents/guardian or by the legal representative, if patients are underage or unable to give their consent. Underage patients and patients unable to give consent must sign the consent in so far as they can.

研究者

发起方
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

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