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

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.

Conditions

• Premature Infant
• Respiratory Distress Syndrome in Premature Infant
• Neurodevelopmental 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.

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• McMaster University

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• McGill University

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Memorial University of Newfoundland

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Laval University

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• Queen's University

  collaborator OTHER

• Université de Sherbrooke

  collaborator OTHER

• University of Alberta

  lead OTHER

Principal Investigators

• Georg Schmolzer, MD, PhD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

0 Minutes

Max Age

10 Minutes

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-27

Primary Completion

2027-09-30

Completion

2029-12-30

Countries

• Canada
• Ireland
• Spain

Study Locations