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临床试验/CTRI/2018/01/011085
CTRI/2018/01/011085已完成未知

â??Therapeutic Hypothermia and neuronal biomarkers in term neonates with Hypoxic Ischemic Encephalopathy â?? a Randomised Controlled Trialâ??

Department of Biotechnology0 个研究点目标入组 154 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
154

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

入选标准

  • 1. Gestational age greater than or equal to 37 weeks
  • 2. ABG(umbilical cord or 1st postnatal hour) pH less than or equal to 7 or BE greater than or equal to -12
  • 3. Evidence of encephalopathy (Sarnatâ??s staging 2 or 3)
  • 4. Any two of the following
  • i. APGAR less than or equal to 6 at 5 min
  • ii. Evidence of fetal distress
  • iii. Assisted ventilation for at least 10 min after birth
  • iv. Evidence of any organ dysfunction
  • v. History of acute perinatal event- intrapartum fetal distress, cord prolapse placental abruption, uterine rupture, maternal trauma, cardiac arrest

排除标准

  • 1. . Infants more than 6 hours of age at the time of randomization
  • 2. Major congenital abnormalities
  • 3. If the baby does not establish spontaneous respiration by 20 minutes
  • 4. Out born babies

研究者

发起方
Department of Biotechnology

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