Therapeutic hypothermia for birth Asphyxia using a new servo-controlled device – A randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effective cooling time (increased cooling effectiveness through effectively maintaining the the rectal temperature within the target temperature range of 33°C to 34°C during the maintenance.)
研究概览
简要总结
The Newborns selected for this trial will be administered therapeutic hypothermia using the servo-controlled Revive device.The baby would be wrapped in the Baby wrap which will be connected to Revive. Once the cooling settings are selected by the Clinician and the treatment is initiated, the device will deliver the cooling for the selected hours and then automatically rewarm the baby back to normo-therm in the duration selected by the Clinician. A key factor determining the success of the treatment is the baby’s Core body temperature being maintained in the target range. Therefore the primary end point of this trial is to determine the effectiveness of cooling by the Revive device, measured by the percentage of time the cooling is maintained in the target range. This is compared with the standard of care followed in the trial sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •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
- •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.
结局指标
主要结局
Effective cooling time (increased cooling effectiveness through effectively maintaining the the rectal temperature within the target temperature range of 33°C to 34°C during the maintenance.)
时间窗: Continuous rectal temperature monitoring until 90 hours of age, and then every 8 h for the first week after birth.
次要结局
- - Time to induction of cooling(- Mortality from any cause before discharge from hospital)