Optimising breathing support at extubation for very preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Royal Women's Hospital
  Melbourne, Victoria, Australia Recruiting
• The Royal Children's Hospital
  Parkville, Victoria, Australia 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: 61(0)424701924

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.