Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Death or severely abnormal Psychomotor Development Index scores on Bayley II
研究概览
简要总结
This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.
详细描述
The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. This trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (HIE) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One clinical indication of hypoxic-ischemic injury
- •cord gas pH ≤ 7.0 or base deficit ≥13,
- •initial infant gas pH < 7.1,
- •Apgar score ≤5 at 10 minutes,
- •continued resuscitation after 5 min,
- •fetal bradycardia with heart rate < 80 beats per minute lasting ≥15 min,
- •postnatal event O2 sat <70% or arterial O2<35 for 20 min with ischemia
- •And two neurologic findings of neonatal encephalopathy, abnormalities of:
- •reflexes,
- •state of consciousness,
- •seizures,
- •posturing,
- •autonomic dysfunction
排除标准
- •Maternal chorioamnionitis,
- •sepsis at birth,
- •birth weight or head circumference <10%,
- •presumed chromosomal abnormality
结局指标
主要结局
Death or severely abnormal Psychomotor Development Index scores on Bayley II
时间窗: 12 months
Death or severe outcomes
次要结局
- bradycardia(0-96 hours)
研究者
Dorothea D. Jenkins
Associate Professor of Pediatrics
Medical University of South Carolina