30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Status:
Not yet recruiting
Trial end date:
2027-12-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
University of Alberta
Collaborators:
University of Sydney University of Toronto University of Valencia