Clinical trial NCT02017691: Cerebral Oxygenation to Guide Supplemental Oxygen
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Oxygen Saturation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cerebral tissue oxygen saturation (crSO2)
timeFrame: 15 minutes
Secondary outcomes:
measure: Mortality
timeFrame: 16 weeks
measure: Cerebral injury
timeFrame: 16 weeks
measure: Neurodevelopmental outcome
timeFrame: 16 weeks
Other outcomes:
measure: Morbidity
timeFrame: 16 weeks
Locations:
city: Graz
country: Austria
facility: Department of Pediatrics, Medical University of Graz
state: Styria
city: Edmonton
country: Canada
facility: Department of Pediatrics, Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: Dep. of Pediatrics, Medical University of Graz
name: Gerhard Pichler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pichler G, Urlesberger B, Baik N, Schwaberger B, Binder-Heschl C, Avian A, Pansy J, Cheung PY, Schmolzer GM. Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr. 2016 Mar;170:73-8.e1-4. doi: 10.1016/j.jpeds.2015.11.053. Epub 2015 Dec 30.