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临床试验/NCT04798794
NCT04798794已完成不适用

Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 4,072 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,072
试验地点
1
主要终点
Acute Neurological Event

研究概览

简要总结

Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.

详细描述

Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Acute Neurological Event

时间窗: Up to 90 days after ECMO initiation

Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item: * Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI * Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG) * Brain death clinically diagnosed

次要结局

  • 28-day mortality(28 days after ECMO start)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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