Cerebral Oxygenation to Guide Supplemental Oxygen

Oxygen Saturation Clinical Trial

— COSGOD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017691
• Other study ID #: 25-295
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 28, 2013
• Last updated: April 16, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Minutes

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxygen Saturation

Intervention

Device:
• Near Infrared Spectroscopy
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.
• Pulse-oximetry
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.

Locations

Country	Name	City	State
Austria	Department of Pediatrics, Medical University of Graz	Graz	Styria
Canada	Department of Pediatrics, Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Countries where clinical trial is conducted

Austria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morbidity	Severe morbidities, Rate of intubation during resuscitation, Need of mechanical ventilation on the first day of life,; Monitoring parameters during the first 15minutes after birth: Mean (SD) HR, Mean (SD) BP, Mean (SD) SpO2, NIRS parameters	16 weeks	Yes
Primary	Cerebral tissue oxygen saturation (crSO2)	Duration in % minute of crSO2 <10th or >90th centile	15 minutes	No
Secondary	Mortality	Rate of mortality	16 weeks	Yes
Secondary	Cerebral injury	Cerebral injury assessed by sonography	16 weeks	Yes
Secondary	Neurodevelopmental outcome	General movements	16 weeks	Yes