NCT03825835 30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
| NCT ID | NCT03825835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Premature Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-06-27 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2022-06-27 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 when the birth happens before 29 weeks' gestation. At this gestational age, the lungs are not fully developed and it is not uncommon for infants to have problems breathing at the time of birth. One complication that can arise is when an infant stops breathing and needs to be resuscitated. When preterm babies need to be resuscitated doctors must take special care because of the small infant size and the immaturity of the brain and lungs. Oxygen is used to resuscitate babies who need it, but unfortunately there is disagreement about the best oxygen concentration to use. Oxygen concentration is important because both too much and too little oxygen can cause brain injury. This research aims to fill this knowledge gap by participating in an international clinical trial to compare the effects of resuscitating babies less than 29 weeks' gestational age with either a low oxygen concentration or a high oxygen concentration. The oxygen concentrations have been selected using the best available knowledge. This will be a cluster randomized trial where each participating hospital will be randomized to either 30 or 60 percent oxygen for the recruitment of 30 infants, and afterwards randomized to the other group for the recruitment of another 30 infants. After the trial, the investigator will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. This research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Georg Schmolzer, MD, PhD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT03825835 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 10 Minutes, studying Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03825835 currently recruiting?
Yes, NCT03825835 is actively recruiting participants. Contact the research team at schmolze@ualberta.ca for enrollment information.
Where is the NCT03825835 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Vancouver, Canada, Winnipeg, Canada and 11 additional locations.
Who is sponsoring the NCT03825835 clinical trial?
NCT03825835 is sponsored by University of Alberta. The principal investigator is Georg Schmolzer, MD, PhD at University of Alberta. The trial plans to enroll 1,200 participants.