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临床试验/ISRCTN15915394
ISRCTN15915394进行中(未招募)未知

Multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress

niversity of Leicester0 个研究点目标入组 1,522 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
1,522

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

性别
All

入选标准

  • 1. Born at 34+0–38+6 weeks of gestation
  • 2. = 24 hours old
  • 3. Respiratory distress defined as:
  • 3.1. FiO2 = 0.3 and < 0.45 needed to maintain SaO2 = 92%, or
  • 3.2. Clinically significant work of breathing, regardless of FiO2
  • 4. Clinical decision to provide non-invasive respiratory support
  • 5. Written parental informed consent

排除标准

  • 1. Major structural or chromosomal abnormality
  • 2. No realistic prospect of survival
  • 3. Prior intubation and/or surfactant administration
  • 4. Known or suspected hypoxic ischaemic encephalopathy
  • 5. Congenital abnormality of the upper or lower respiratory tract
  • 6. Known or suspected neuromuscular disorder

研究者

发起方
niversity of Leicester

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