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

NARecruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

September 30, 2027

Study Completion Date

December 30, 2027

Conditions
Premature InfantRespiratory Distress Syndrome in Premature InfantNeurodevelopmental Outcome
Interventions
DRUG

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."

DRUG

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."

Trial Locations (19)

Unknown

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

T5H 3V9

ACTIVE_NOT_RECRUITING

Royal Alexandra Hospital, Edmonton

A1B 3V6

RECRUITING

Janeway Children's Health and Rehabilitation Centre, St. John's

L8S 4K1

RECRUITING

Neonatal Intensive Care Unit - Hamilton Health Sciences, Hamilton

All Listed Sponsors
collaborator

University of Toronto

OTHER

collaborator

University of Sydney

OTHER

collaborator

University of Valencia

OTHER

collaborator

Dalhousie University

OTHER

collaborator

McMaster University

OTHER

collaborator

University of Manitoba

OTHER

collaborator

McGill University

OTHER

collaborator

University of Calgary

OTHER

collaborator

Memorial University of Newfoundland

OTHER

collaborator

University College Cork

OTHER

collaborator

University of British Columbia

OTHER

collaborator

Laval University

OTHER

collaborator

Université de Montréal

OTHER

collaborator

University of Ottawa

OTHER

lead

University of Alberta

OTHER