Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth (COSGOD) - a Prospective Two-centre Randomized Controlled Pilot Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Cerebral tissue oxygen saturation (crSO2)
研究概览
简要总结
Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth.
Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study.
Design: A prospective two-centre randomized controlled pilot feasibility study
Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth.
Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm neonates during the first 15 minutes after birth
Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or >90th centile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonate <34+0 weeks after caesarean section
- •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
Near Infrared Spectroscopy
crSO2 measurements in addition SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth
干预措施: Near Infrared Spectroscopy (Device)
Pulse-oximetry
Only SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth
干预措施: Pulse-oximetry (Device)
结局指标
主要结局
Cerebral tissue oxygen saturation (crSO2)
时间窗: 15 minutes
Duration in % minute of crSO2 \<10th or \>90th centile
次要结局
- Cerebral injury(16 weeks)
- Mortality(16 weeks)
- Neurodevelopmental outcome(16 weeks)
研究者
Pichler Gerhard, MD.
Assoc. Prof.
Medical University of Graz