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Intervention (21% oxygen during CC+SI) for Neonatal Asphyxia (SURV1VE-O2 Trial)
N/A
Waitlist Available
Led By Georg Schmolzer, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 minutes of chest compression
Awards & highlights
SURV1VE-O2 Trial Summary
This trial will test whether giving chest compressions to newborn babies without stopping to give rescue breaths will improve outcomes.
Eligible Conditions
- Neonatal Asphyxia
- Cardiac Arrest
- Neonatal Bradycardia
SURV1VE-O2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 minutes of chest compression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 minutes of chest compression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Return of spontaneous Circulation
Secondary outcome measures
Mortality
Number of Epinephrine dosses during resuscitation
Brain
SURV1VE-O2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (21% oxygen during CC+SI)Experimental Treatment1 Intervention
Infants randomized into the "21% oxygen CC+SI group" will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression.
The SI will be delivered over a period of 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will perform an assessment of the newborn's heart rate.
If heart rate is >60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains <60/min continue with CC+SI for another 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI.
During CC+SI the clinical team will only use 21% oxygen.
Group II: Intervention (100% oxygen during CC+SI)Active Control1 Intervention
Infants randomized into the "100% oxygen CC+SI group" will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression.
The SI will be delivered over a period of 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will perform an assessment of the newborn's heart rate.
If heart rate is >60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains <60/min continue with CC+SI for another 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI.
During CC+SI the clinical team will only use 100% oxygen.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,946 Total Patients Enrolled
3 Trials studying Neonatal Asphyxia
1,755 Patients Enrolled for Neonatal Asphyxia
Georg Schmolzer, MD, PhDPrincipal InvestigatorUniversity of Alberta
3 Previous Clinical Trials
1,300 Total Patients Enrolled
1 Trials studying Neonatal Asphyxia
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