Optimising breathing support at extubation for very preterm infants
PrePAP: Pre-Extubation Continuous Positive Airway Pressure in Very Preterm Infants: A Randomised Controlled Trial
This trial will try starting nasal CPAP before removing the breathing tube versus starting it after extubation to see if that reduces oxygen drops in very preterm infants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 0 Hours and up |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 2 sites (Melbourne, Victoria and 1 other locations) |
| Trial ID | NCT07251790 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two common extubation approaches in very preterm infants born between 22+0 and 29+6 weeks who are being electively extubated to nCPAP. One group receives nCPAP started prior to removal of the endotracheal tube (prePAP) and the other group receives the usual practice of nCPAP started after extubation. The primary outcome is oxygen desaturation in the four hours immediately after extubation, with additional monitoring for extubation failure, re‑intubation and short-term respiratory outcomes. The trial is conducted in participating NICUs in Melbourne, Australia.
Who should consider this trial
Good fit: Infants born at 22+0 to 29+6 weeks gestation, admitted to a participating NICU, who have been on invasive ventilation for at least 4 hours and are being electively extubated to nCPAP for the first time with parental consent are ideal candidates.
Not a fit: Infants with major congenital cardiac/respiratory/gastrointestinal anomalies, severe pulmonary hypoplasia, those outside the gestational age window, or those requiring emergency extubation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, starting nCPAP before extubation could reduce early oxygen desaturations and lower the risk of re‑intubation and lung injury in very preterm infants.
How similar studies have performed: Small observational reports and physiologic rationale suggest prePAP may improve stability at extubation, but robust randomized evidence is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The infant is admitted to participating NICU * The infant is born between 22+0 to 29+6 weeks gestational age * The infant has been on a form of invasive mechanical ventilation for at least 4 hours * The infant is being electively extubated for the first time from invasive mechanical ventilation to nCPAP * The infant is clinically stable (as per clinical and research team consensus) * The parent(s) or legal guardian(s) provides prospective informed consent. Exclusion Criteria: * The infant is born \<22 weeks or \>30 weeks gestational age * The infant has a major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes * The infant has severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life * The infant is receiving invasive mechanical ventilation via nasotracheal intubation * The infant is planned for extubation to any other mode of non-invasive respiratory support than nCPAP, or no respiratory support * Refusal of informed consent from the parent(s), or the infant does not have a guardian who can provide informed consent.
Where this trial is running
Melbourne, Victoria and 1 other locations
- The Royal Women's Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)
- Joan Kirner Women's and Children's Hospital — Saint Albans, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Georgia S Stephen, BBmedSc BBiomedSc(Hons) — Murdoch Childrens Research Institute
- Study coordinator: Georgia S Stephen, BBmedSc BBiomedSc(Hons)
- Email: georgia.stephen@mcri.edu.au
- Phone: 424701924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.