ISRCTN89547571已完成未知
Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: a randomised controlled trial
Imperial College London (UK)0 个研究点目标入组 325 人开始时间: 2000年9月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 325
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
- 性别
- All
入选标准
- •Infants will be assessed sequentially by criteria 1, 2 and 3 listed below:
- •1. Infants greater than or equal to 36 weeks gestation admitted to the Neonatal Intensive Care Unit (NICU) with ONE of the following:
- •1.1. Apgar score of less than five at ten minutes after birth
- •1.2. Continued need for resuscitation, including endotracheal or mask ventilation, at ten minutes after birth
- •1.3. Acidosis defined as either umbilical cord pH or any arterial pH within 60 minutes of birth less than pH 7.00
- •1.4. Base deficit greater than or equal to 16 mmol/l in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
- •If the infant meets criteria 1 then assess for neurological abnormality (by trained study personnel):
- •2. Moderate to severe encephalopathy consisting of altered state of consciousness (lethargy, stupor or coma) and at least one or more of hypotonia, abnormal reflexes including oculomotor or pupillary abnormalities, an absent or weak suck or clinical seizures, as recorded by study personnel.
- •If the infant meets criteria 1 & 2 then assess by amplitude-integrated electroencephalography (aEEG) (read by trained study personnel):
- •3. At least 30 minutes duration of amplitude integrated EEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
- •3.1. Normal background with some seizure activity
- •3.2. Moderately abnormal activity
- •3.3. Suppressed activity
- •3.4. Continuous seizure activity
- •1. Previously specified that they do not want to be contacted again
- •2. Previously recruited in the TOBY study within 6 hours of birth
- •3. Confirmed moderate or severe neonatal encephalopathy
排除标准
- •1. Infants expected to be greater than 5.5 hours of age at the time of randomization
- •2. Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis
- •Non-participation will only occur if consent is not obtained or contact with the family cannot be achieved. Children who did not take part in the TOBY study are not eligible.
研究者
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