Airoplane: Air or oxygen for preterm infants; an embedded trial
- Conditions
- respiratory distressRespiratory - Other respiratory disorders / diseasesReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12621001267842
- Lead Sponsor
- Murdoch Children's Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1200
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.
Infants will be excluded if they:
oare born outside the criteria above, including those who do not receive respiratory support during transition
ohave any known major congenital cardiorespiratory or craniofacial anomaly likely to affect transition, or
oa prior decision has been made not to provide intensive care (i.e. comfort care),
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is the need for ongoing respiratory support at the time of leaving the delivery room. Ongoing respiratory support will include the need for intubation and mechanical ventilation, or the use of non-invasive respiratory supports such as continuous positive airway pressure (CPAP) or nasal high flow therapy (nHF), including any requirement for surfactant therapy. This data will be collected via review of the patient's medical record.[ Leaving the delivery room]
- Secondary Outcome Measures
Name Time Method