Cerebral Oxygenation to Guide Supplemental Oxygen

Phase 1

Completed

• Conditions: Oxygen Saturation
• Interventions: Device: Near Infrared Spectroscopy; Device: Pulse-oximetry

• Registration Number: NCT02017691
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-28
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Primary Completion: 2015-02
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near Infrared Spectroscopy	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
Pulse-oximetry	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

Primary Outcome Measures

Name	Time	Method
Cerebral tissue oxygen saturation (crSO2)	15 minutes	Duration in % minute of crSO2 \<10th or \>90th centile

Secondary Outcome Measures

Name	Time	Method
Mortality	16 weeks	Rate of mortality
Neurodevelopmental outcome	16 weeks	General movements
Cerebral injury	16 weeks	Cerebral injury assessed by sonography

Trial Locations

Locations (2)

Department of Pediatrics, Medical University of Graz; 🇦🇹 Graz, Styria, Austria

Department of Pediatrics, Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada