CTRI/2020/06/025902招募中未知
Therapeutic hypothermia for birth Asphyxia using a new servo-controlled device â?? A randomised controlled trial.
Sensivision Health Technologies Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
- •i. Inborn baby with GA >= 36 weeks and BW >= 2000 grams
- •ii. Age less than 6 hours
- •iii. Umbilical arterial (or gas within 1 hour of life) pH <=7 or Base deficit >= 12 meq/L. If blood gas is unavailable, then any one of the following can be used
- •a) APGAR <= 5 at 10 min
- •b) Assisted ventilation for at least 10 min after birth
- •c) History of acute perinatal event- intrapartum fetal distress, cord prolapse, placental abruption, maternal trauma, uterine rupture, cardiac arrest
- •iv. Presence of moderate or severe encephalopathy by clinical examination (Modified Sarnat & Sarnat staging) consisting of:
- •a) Seizures b) Altered state of consciousness (reduced or absent response to stimulation) c) Abnormal tone (focal or general hypotonia, or flaccid) d) Abnormal primitive reflexes
- •(weak or absent suck or Moro response)
排除标准
- •1) Major congenital abnormalities
- •2) Babies who fail to establish spontaneous respiration at 20 minutes of life
- •3) Absent heart rate at 10 min of age despite adequate resuscitation
- •4) Risk of imminent death
研究者
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