Cerebral Oxygenation to Guide Supplemental Oxygen

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Oxygen Saturation

Intervention / Treatment
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* Device: Near Infrared Spectroscopy
* Device: Pulse-oximetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm neonate <34+0 weeks after caesarean section Decision to conduct full life support Written informed consent Exclusion Criteria: No decision to conduct full life support No written informed consent Congenital malformation

Ages Eligible for Study
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Maximum Age: 15 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Near Infrared Spectroscopy<br>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 | Device: Near Infrared Spectroscopy<br>* If crSO2 is <10th centile, CPAP via face mask will be started or oxygen support will be increased depending SpO2, on the infants breathing efforts and the heart rate. If crSO2 remains stable >10th centile, or if crSO2 is > 90th centile CPAP via face mask will be stopped or FiO2 will be reduced depending on SpO2, the infants breathing efforts and the heart rate.<br>|
| Other: Pulse-oximetry<br>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 | Device: Pulse-oximetry<br>* If SpO2 remains <10th centile, respiratory support via face mask will be started or FiO2 will be increased depending on the infants breathing efforts and the heart rate. If SpO2 remains stable or if SpO2 is >90th centile respiratory support via face mask will be stopped or FiO2 will be reduced depending on the infants breathing efforts and the heart rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oxygen saturation (crSO2) | Duration in % minute of crSO2 <10th or >90th centile | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of mortality | 16 weeks | 
| Cerebral injury | Cerebral injury assessed by sonography | 16 weeks | 
| Neurodevelopmental outcome | General movements | 16 weeks |