Oxygen Saturation Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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