Improving Early Decisions in Neonatal Encephalopathy by Monitoring Heartbeat Variability
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- Prognostic accuracy of HRV to predict adverse neurodevelopment outcome
研究概览
简要总结
This study will find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time
详细描述
BACKGROUND
Hypoxic ischaemic encephalopathy (HIE) is the single most common cause of death and lifelong neurodisability in term babies. Although cooling treatment improves outcomes for these babies, early identification (within six hours of birth) of 'at risk infants' remains challenging. Consequently, not all babies who need treatment will receive it and other babies receive treatment unnecessarily. Furthermore, neuroprotection from cooling may be lost if baby remains stressed during treatment, but accurate methods of measuring stress in babies are lacking.
AIMS
Primary aim:
To examine the accuracy of heartbeat variability (HRV), within six hours of birth, to predict adverse neurodevelopmental outcome at 18 to 22 months in encephalopathic babies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Hours 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term babies (>36 weeks)
- •Requiring resuscitation at birth due to perinatal asphyxia and/or 5 minute Apgar score <
- •Structured clinical neurological examination (modified Sarnat stage) within six hours of age suggestive of encephalopathy (mild, moderate or severe)
- •Age less than six hours at the time of admission to the neonatal unit
排除标准
- •Babies with lethal congenital malformations or cardiac conditions that could affect heartbeat variability
- •Participation in any controlled trials of investigational medical products (C-TIMPS)
- •HEALTHY COHORT
- •Inclusion criteria:
- •Healthy full term babies (>36 weeks) and birth weight between 9th to 91st centile
- •Age less than six hours at the time of study enrolment
- •Exclusion criteria
- •Babies requiring any medication or phototherapy
- •Perinatal maternal fever
结局指标
主要结局
Prognostic accuracy of HRV to predict adverse neurodevelopment outcome
时间窗: 18-22months
Various linear and non-linear HRV indices will be compared with neurodevelopment at 18 to 22 months
次要结局
- Correlation between HRV and salivary cortisol levels(first 5 days of live)