Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth: An Investigator-initiated Randomised Multi-centre Multinational Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 655
- 试验地点
- 12
- 主要终点
- Mortality and/or occurrence of cerebral injury
研究概览
简要总结
The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and heart rate and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).
详细描述
Background
The transition to life after birth is a complex physiological process where the neonate has to establish sufficient ventilation and changes from intra-uterine circulation to extra-uterine circulation take place. During these processes the neonate has to provide the brain with adequate perfusion and oxygen delivery to maintain normal cerebral tissue oxygenation and activity. If hypoxia and bradycardia both common events during immediate transition in preterm neonates occur, cerebral hypoxia-ischaemia may cause perinatal brain injury that is the major causes of mortality and long term neurodevelopmental impairment.
Objectives
The primary objective of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR) and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).
Hypothesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates less than completed 32 weeks,
- •Decision to conduct full life support,
- •Written informed consent.
排除标准
- •No decision to conduct full life support,
- •No written informed consent,
- •Congenital malformation.
研究组 & 干预措施
Study group: Invos 5100
Supplemental oxygen support and respiratory/circulatory support is guided by cerebral regional tissue oxygenation (crSO2) measured with near-infrared spectroscopy ("INVOS 5100" ), in addition to the SpO2/HR (oxygen saturation/heart rate) monitoring according to routine.
干预措施: Study group (Device)
Control group: Routine care
Supplemental oxygen support and respiratory/circulatory support is guided by SpO2/HR monitoring according to routine - The resuscitation team is blinded to the crSO2 monitoring.
干预措施: Control group (Other)
结局指标
主要结局
Mortality and/or occurrence of cerebral injury
时间窗: up to 19 weeks after birth
Number of patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia
次要结局
- Frequency of neonatal morbidities(up to 19 weeks after birth)
- Sex(up to 19 weeks after birth)
- Gestational age(up to 19 weeks after birth)