Cerebral Oxygenation to Guide Supplemental Oxygen (COSGOD)

Medical University of Graz

Status and phase: Completed; Phase 2; Phase 1

Conditions: Oxygen Saturation

Treatments: Device: Near Infrared Spectroscopy; Device: Pulse-oximetry

Study type: Interventional

Funder types: Other

Identifiers

NCT02017691

25-295

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 15 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Near Infrared Spectroscopy

Experimental group

Description:

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

Treatment:

Device: Near Infrared Spectroscopy

Pulse-oximetry

Other group

Description:

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

Treatment:

Device: Pulse-oximetry