NL-OMON34433尚未招募不适用
Pharmacokinetics and Pharmacodynamics of Medication in Asphyxiated Newborns During Controlled Hypothermia PharmaCool National Multicenter Study. - PharmaCool National Multicenter Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Any newborn :;1) with a gestational age > 36 weeks and a birth weight > 3 kg;
- •2) with Apgar Score at 5 minutes postnatal < 5;
- •3) with continued resuscitation at 10 minutes postnatally;
- •4) with 1 hour postnatal bloodgas analysis with pH < 7.0 or base deficit > 16
- •5) with clinical signs of moderate to severe encephalopathy (defined as a Thomson score of >7 or a Sarnat score of >1)
- •6) who is undergoing neuroprotective treatment by controlled hypothermia < 6 hours postnatally.
排除标准
- •1) congenital hepatic or renal pathology (as this makes interpretation of PKPD results impossible);
- •2) without central venous line or arterial bloodstream access for blood sampling;
- •3) without written parental consent to participate following informed consent interview.
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