None listed
Conditions
Brief summary
The AIROPLANE trial aims to evaluate the effect of commencing respiratory support at birth, in preterm infants born 32 to 35 completed weeks’ gestation, with either 30% or 21% oxygen. The primary outcome is the need for ongoing respiratory support upon leaving the delivery room. This study will be conducted as an unblinded, multi-centre, cluster randomised crossover trial, with recruitment occurring over a 2 year period, overlapping with GenV recruitment. We hypothesise that if respiratory support is required during transition at birth, commencing with 30% oxygen will be superior to commencing with 21% oxygen, resulting in improved transition and less need for ongoing respiratory support.
Interventions
All preterm infants of 32-35 completed weeks’ gestation, born in participating Victorian hospitals during the 2 year recruitment period (early 2022 - early 2024), who require respiratory support at delivery will be eligible for inclusion.
Treatment A will be the initial use of 21% oxygen during respiratory support (via face mask or nasal prongs) in the delivery room. This treatment will be delivered by the clinician attending the birth. All other interventions will be initiated according to the
All preterm infants of 32-35 completed weeks’ gestation, born in participating Victorian hospitals during the 2 year recruitment period (early 2022 - early 2024), who require respiratory support at delivery will be eligible for inclusion. Treatment A will be the initial use of 21% oxygen during respiratory support (via face mask or nasal prongs) in the delivery room. This treatment will be delivered by the clinician attending the birth. All other interventions will be initiated according to the Australian Resuscitation Council (ARC) / Victorian NeoResus (neoresus.org.au) protocols, and local guidelines. No change to the randomised oxygen concentration will be permitted prior to 3 minutes of life, or within 1 minute of commencement of respiratory support, whichever is later. This 1-minute requirement mitigates for the practice of delayed/deferred cord clamping which is currently the recommended practice for all babies of this gestational age (GA) across Victoria for a duration of 30-60 seconds. The very large majority of these infants will not receive respiratory support until after the umbilical cord has been cut. However, if at any stage, an infant is bradycardic with a heart rate <60 beats per minute (bpm), or requires chest compressions or intubation, supplemental oxygen should be delivered as per local resuscitation guidelines. Beyond the 3-minute time period (or 1-minute post commencement of respiratory support, if after 3 minutes), oxygen concentration should be titrated against peripheral oxygen saturations (SpO2) measured by pulse oximetry, as recommended by the ARC/ NeoResus guidelines. Each hospital will be randomised to use one oxygen strategy for half of the trial recruitment period, and then switch to the other strategy for the second half of the recruitment period. Hospitals will be randomly allocated to the order in which these two interventions will be assigned. Only one crossover of interventions will occur at each site. Adherence to the intervention will be monitored by the completion of a brief survey, which clinician's can access via a QR code to be displayed near the resuscitaire.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
32 Weeks to 35 Weeks
Healthy volunteers
No
Inclusion criteria
Each infant must meet all of the follwing to be included in the study: o born in a participating Victorian hospital across the 2 year trial period (2022/2023) o born between at 32+0 and 35+6 weeks of gestation o receive respiratory support in the delivery room to support transition, respiratory support includes any facemask support, such as for the provision of CPAP, intermittent positive pressure ventilation, intubation, or any combination of these interventions.
Exclusion criteria
Infants will be excluded if they: o are born outside the criteria above, including those who do not receive respiratory support during transition o have any known major congenital cardiorespiratory or craniofacial anomaly likely to affect transition, or o a prior decision has been made not to provide intensive care (i.e. comfort care),
Outcome results
None listed