New breathing tube removal method may protect fragile preterm lungs
NCT ID NCT07251790
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study looks at a new method for removing breathing tubes from very premature babies (born before 32 weeks). Normally, doctors remove the tube first and then put on a gentle breathing mask. The new method puts the mask on first, before removing the tube. Researchers want to see if this helps babies keep their oxygen levels more stable. About 134 babies will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 hours and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Joan Kirner Women's and Children's Hospital
RECRUITINGSaint Albans, Victoria, 3021, Australia
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The Royal Children's Hospital
RECRUITINGParkville, Victoria, 3052, Australia
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The Royal Women's Hospital
RECRUITINGMelbourne, Victoria, 3050, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gentler breathing support may help preterm babies avoid breathing tubes
- Ultrasound may help doctors time lifesaving lung treatment for preterm infants
- Could a muscle relaxant make newborn intubation safer?
- New study tests safer sedation for tiny lungs
- Team sedation strategy may shorten ventilator time for kids
- Which method helps premature babies breathe best? new study aims to find out.