ISRCTN62175998已完成未知
Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia: a pilot study of the Neonatal Neuroprotection of Asphyxiated Tuscan Infants (NeoNATI) Network
A. Meyer University Children?s Hospital (Italy)0 个研究点目标入组 60 人开始时间: 2011年6月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
- 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22950861 2. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28274169 (added 16/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Newborns with gestational age > 36 weeks and birth weigh > 1800 g with at least 1 of the following:
- •1.1. Apgar score < 5 at 10 minutes
- •1.2. Persisting need for resuscitation, including endotracheal intubation or mask ventilation 10 minutes after birth
- •1.3. Acidosis (pH <7.0, base deficit >-16 mmol/L in umbilical cord blood or arterial, venous or capillary blood) within 60 minutes from birth
- •2. Moderate to severe encephalopathy, consisting of altered state of consciousness (irritability, lethargy, stupor, or coma) and > 1 of the following signs:
- •2.1. Hypotonia
- •2.2. Abnormal reflexes, including oculomotor or pupil abnormalities
- •2.3. Absent or weak suck
- •2.4. Clinical seizures
- •3. Abnormal ambulatory electroencephalogram (aEEG)
排除标准
- •1. Congenital abnormalities
- •2. Congenital viral infections
- •3. Evidence of encephalopathy other than HIE
研究者
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