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临床试验/PACTR202011513390736
PACTR202011513390736尚未招募4 期

The role of a multi-strain probiotic in very low birth weight infants.

Safeline Pharmaceuticals0 个研究点目标入组 200 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
0 Day(s) 至 1 Month(s)(—)
性别
All

入选标准

  • •Male and female preterm infants (= 27 and < 37 weeks gestational age).
  • •Preterm infants with very low birth weight and an extremely low birth weight (<1500g and <1000g).
  • •Written maternal consent to the study.

排除标准

  • •Infants with major congenital malformations and/ or developmental disabilities.
  • •Infants born with a laboratory-confirmed bloodstream infection (CRP >10 in the first 36h of life).
  • •Infants born <750g (as per Periviability protocol in TBCH, these infants receive only specific supportive measures and no NICU care, and thus poses a high lost to follow-up rate due to high mortality and reduces the statistical validity of the study).
  • •Preterm infants with major gastro-intestinal abnormalities or surgery of the gastro-intestinal tract.
  • •Preterm infants whose mothers were not available within 72 hours post birth / whose mothers did not want their babies to take part in the study (refusal).
  • •If the mother is in the intensive care unit (ICU) that cannot give consent (e.g. ventilated, sedated, delirious or unable to provide consent).
  • •Premature infant whose mother gave them up for adoption.

研究者

发起方
Safeline Pharmaceuticals

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