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临床试验/EUCTR2010-023988-17-CZ
EUCTR2010-023988-17-CZ进行中(未招募)1 期

Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn. - HIP Trial

BrepCo Biopharma Limited0 个研究点目标入组 830 人开始时间: 2014年4月24日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
830

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

  • Gestational age from 23 weeks at birth to less than 28 completed weeks (i.e. up to and including 27 weeks and 6 days).
  • Within 72 hours of birth.
  • An indwelling arterial line, suitably calibrated and zeroed, to monitor blood pressure.
  • A pre-trial cranial ultrasound scan free of grade III-IV IVH or cystic PVL.
  • A mean blood pressure (BP) 1 mmHg or more below a mean BP value equivalent to the GA in completed weeks, which persists over a 15 minute period.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 830
  • 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

  • Infant is considered non-viable by attending clinicians.
  • Life-threatening congenital abnormalities including congenital heart disease and chromosomal abnormalities.
  • Infants known to require surgical treatment.
  • Hydrops Fetalis.

研究者

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