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Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study

Study acronym: PrePAP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 2 to 3v7
  2. Minor Site details revised at 1 of 2 sitesv6
  3. Notable Recruitment opened Eligibility criteria shortened, about 15 wordsv5 Show 1 more changeShow less
    • Eligibility criteria shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 31, 2026 to May 4, 2026 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 31, 2026 to May 4, 2026
    • Site details revised at 2 of 2 sites
  5. Notable Start date: Jan 31, 2026 to Mar 31, 2026 Primary and study completion dates: Jan 31, 2028 to Mar 31, 2028v3 Show 1 more changeShow less
    • Primary and study completion dates: Jan 31, 2028 to Mar 31, 2028
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Many babies born very preterm (\<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs. To reduce this damage, doctors and nurses try to change babies to gentler breathing support that does not require a breathing tube. This is usually done using a method called nasal continuous positive airway pressure (nCPAP) that uses a nosepiece to deliver breaths. This process of removing the breathing tube is called "extubation". Many babies will need the breathing tube put back in after extubation (for various reasons) and this is independently associated with poorer outcomes. This research study aims to compare two ways of performing extubation - both of which are already used regularly by doctors and nurses. The "standard extubation" approach involves taking a baby's breathing tube out first, then applying the nosepiece and starting nCPAP. The more recent approach, called "prePAP", involves applying the nosepiece and starting nCPAP before taking the breathing tube out. Previous research suggests that a prePAP approach may provide better support for babies during extubation. However, larger studies are required before this approach is more commonly used. This study is investigating whether extubating the baby with prePAP is better than extubating the baby without prePAP. The main question it aims to answer is: Does initiating nCPAP before extubation in very preterm babies reduce the fall in their oxygen levels post-extubation?
Trial Details
NCT Number NCT07251790
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: Western Health, Australia, Royal Women's Hospital, Melbourne, Australia
Conditions Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov