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 be eligible.

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.

Follow-up

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.

Participating sites

  • John Hunter Children's Hospital, New Lambton Heights NSW
  • The Royal Hospital for Women, Randwick NSW
  • Nepean Hospital, Kingswood NSW
  • Gold Coast University Hospital, Southport QLD