30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants

Recruiting now · Not applicable

Conditions studied: Premature Infant, Respiratory Distress Syndrome in Premature Infant, Neurodevelopmental Outcome

In brief

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.

Key facts

Study ID

NCT03825835

Run by

University of Alberta

People needed

1200

Starts

2022-06-27

Expected to finish

2029-12-30

Last updated by the study team

2026-05-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Health Sciences — Winnipeg, Manitoba, Canada (enrolling)
• Chu University Laval — Québec, Quebec, Canada (enrolling)
• Université de Sherbrooke — Sherbrooke, Quebec, Canada (enrolling)
• University College Cork — Cork, Ireland (enrolling)
• BC Children — Vancouver, British Colubia, Canada (enrolling)
• Queen's University — Kingston, Ontario, Canada
• CHEO — Ottawa, Ontario, Canada
• Neonatal Intensive Care Unit - Mount Sinai Hospital — Toronto, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• McGill Univeristy — Montreal, Quebec, Canada
• Hospital Germans Tries i Pujol — Barcelona, Spain
• Hospital Universitario Dexeus — Barcelona, Spain
• Hospital de la Arrixaca — El Palmar, Spain
• Hospital Las Palmas — Las Palmas de Gran Canaria, Spain
• Hospital de Asturias — Oviedo, Spain
• Foothills Hospital — Calgary, Alberta, Canada
• Hospital Universitario Materno Infantil Miguel Servet — Zaragoza, Spain
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• Janeway Children's Health and Rehabilitation Centre — St. John's, Newfoundland and Labrador, Canada
• Newborn Health - IWK Health Centre — Halifax, Nova Scotia, Canada
• Neonatal Intensive Care Unit - Hamilton Health Sciences — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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