1,200
Participants
Start Date
June 27, 2022
Primary Completion Date
September 30, 2027
Study Completion Date
December 30, 2027
30% oxygen group
"Infants 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
"Infants 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."
ACTIVE_NOT_RECRUITING
Foothills Hospital, Calgary
RECRUITING
BC Children, Vancouver
RECRUITING
Health Sciences, Winnipeg
RECRUITING
Newborn Health - IWK Health Centre, Halifax
RECRUITING
CHEO, Ottawa
ACTIVE_NOT_RECRUITING
Neonatal Intensive Care Unit - Mount Sinai Hospital, Toronto
ACTIVE_NOT_RECRUITING
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
McGill Univeristy, Montreal
RECRUITING
Chu University Laval, Québec
RECRUITING
University College Cork, Cork
NOT_YET_RECRUITING
Hospital Germans Tries i Pujol, Barcelona
NOT_YET_RECRUITING
Hospital Universitario Dexeus, Barcelona
NOT_YET_RECRUITING
Hospital de la Arrixaca, El Palmar
NOT_YET_RECRUITING
Hospital Las Palmas, Las Palmas de Gran Canaria
NOT_YET_RECRUITING
Hospital de Asturias, Oviedo
NOT_YET_RECRUITING
Hospital Universitario Materno Infantil Miguel Servet, Zaragoza
ACTIVE_NOT_RECRUITING
Royal Alexandra Hospital, Edmonton
RECRUITING
Janeway Children's Health and Rehabilitation Centre, St. John's
RECRUITING
Neonatal Intensive Care Unit - Hamilton Health Sciences, Hamilton
University of Toronto
OTHER
University of Sydney
OTHER
University of Valencia
OTHER
Dalhousie University
OTHER
McMaster University
OTHER
University of Manitoba
OTHER
McGill University
OTHER
University of Calgary
OTHER
Memorial University of Newfoundland
OTHER
University College Cork
OTHER
University of British Columbia
OTHER
Laval University
OTHER
Université de Montréal
OTHER
University of Ottawa
OTHER
University of Alberta
OTHER