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.
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
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
Crossover
30% oxygen group
DrugInfants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age. Intervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.
60% oxygen group
DrugInfants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age. Intervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.
Number of participants with composite outcome of all-cause mortality or the presence of a major neurodevelopmental outcomes
Defined as any one of the following: Mortality or (i) cerebral palsy with an inability to walk unassisted; (ii) major developmental delay involving cognition or language; or (iii) visual (cannot fixate/legally blind, or corrected acuity \< 6/60 in both eyes) or hearing impairment (requiring a hearing aid or cochlear implants).
Number of intubation in the delivery room
Number of infants intubated in the delivery room
Death in the Neonatal Intensive Care Unit
Number of infants died after admission in the Neonatal Intensive Care Unit
Number of participants who died in the delivery room
Number of infants died in the delivery room during resuscitation
Number of participants with severe brain injury on cranial ultrasound
Severe grade 3 and 4 intraventricular or intraparenchymal hemorrhage according to Papile \[44\], periventricular leukomalacia, or ventriculomegaly based on neuroimaging studies (timing and frequency of imaging based on local site practices)
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
University of Toronto
Collaborator
University of Sydney
Collaborator
Dalhousie University
Collaborator
McMaster University
Collaborator
University of Manitoba
Collaborator
McGill University
Collaborator
University of Calgary
Collaborator
Memorial University of Newfoundland
Collaborator
University College Cork
Collaborator
University of British Columbia
Collaborator
Laval University
Collaborator
Université de Montréal
Collaborator
University of Ottawa
Collaborator
Queen's University
Collaborator
Université de Sherbrooke
Collaborator
