Status:
RECRUITING
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University of Toronto
University of Sydney
Conditions:
Premature Infant
Respiratory Distress Syndrome in Premature Infant
Eligibility:
All Genders
Up to 10 years
Phase:
NA
Brief Summary
Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly wh...
Detailed Description
Purpose: Over the last 10 years, recommendations regarding the ideal level of oxygen for resuscitation in preterm infants have changed from 100 percent, down to low levels of oxygen (\<30 percent), up...
Eligibility Criteria
Inclusion
- Infants born at 23 0/7 weeks to 28 6/7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities
Exclusion
- Infants who are outborn - initial resuscitation not performed at the study centre
- Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants
- Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes
- Infants who will not receive full resuscitation at birth- these infants will not receive resuscitation
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03825835
Start Date
June 27 2022
End Date
December 30 2029
Last Update
December 26 2025
Active Locations (21)
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1
Foothills Hospital
Calgary, Alberta, Canada
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
3
BC Children
Vancouver, British Colubia, Canada
4
Health Sciences
Winnipeg, Manitoba, Canada