Trial Synopsis

Trial Title

Air or Oxygen for Preterm infants; AN Embedded trial

Aim

To evaluate the effect of commencing respiratory support at birth in preterm babies born at 32 weeks to 35 weeks and 6 days of pregnancy, with either 30% or 21% oxygen.

Trial Design

Unblinded, multi-centre, cluster randomised crossover trial.

Research Question

For babies born at 32 – 35 weeks and 6 days of pregnancy who require breathing support in the delivery room, does the initial use of 30% oxygen reduce the need for ongoing breathing support compared with using 21% oxygen (air)?

Trial Population

Preterm babies of 32-35 weeks and 6 days of pregnancy, born in participating hospitals in Victoria and NSW.

Setting

Victorian and NSW tertiary and non-tertiary maternity hospitals.

Treatment Pathway A

Initial use of 21% oxygen during breathing support in the delivery room.

Treatment Pathway B

Initial use of 30% oxygen during breathing support in the delivery room.

Outcomes

Primary (Main) Outcome
Rate of use of breathing support after the first few minutes when leaving the delivery room.

Selected Secondary Outcomes
Duration and type of breathing support and need for additional oxygen treatment, duration of hospital admission
Long term outcomes will be provided for a subset of babies who are also enrolled in the GenV Study (genv.org.au)

Sample Size

Sample size is estimated to be 1,200 infants enrolled from approximately 20 Victorian and NSW maternity hospitals.  

Description of study sites

Victorian and NSW public or private maternity hospitals accommodating births of infants below 36 weeks of pregnancy.

Recruitment Period

A maximum of 30 months from enrolment of the first baby.

Participant duration

From birth until hospital discharge.
For those babies who are co-enrolled in GenV, long-term outcomes will be linked via the GenV data set.

Randomisation schedule

Cluster randomisation by study site, with one crossover between treatments at the halfway mark of the recruitment period at that site.