Eligibility and study procedures
Who is eligible?
Any premature baby born between 23 weeks and 28 weeks 6 days
gestation whose parent has signed an informed consent form is
eligible for the trial. The study procedures take place during
delivery and as such, parents will need to sign the informed
consent form before delivery.
Who may not be eligible?
Babies with known cardiopulmonary abnormalities or congenital
malformations that could affect the outcomes of the trial may not
What are the study procedures?
Once the informed consent form has been signed and delivery is
about to take place, the baby is randomised by computer to receive
either higher or lower oxygenation at delivery.
The lower oxygenation group starts at 21% oxygen (room air) and
targets a slightly lower oxygen trajectory during the first 10
minutes of life. The higher oxygenation group starts at 60% oxygen
and targets a slightly higher oxygen trajectory during the first 10
minutes of life. Both of these oxygen levels are within
internationally accepted recommendations.
Babies are followed until 2 years corrected for gestation.
Families will be contacted every 6 months to ensure contact details
are current. At 2 years parents are asked to complete the Ages and
Stages Questionnaire, which takes about 15 minutes. Babies may be
brought it to hospital for an in-person follow-up assessment if
that is standard care for the centre.