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

RecruitingNAAges 0 Hours - anyAllMurdoch Childrens Research Institute
NCT07251790 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 br

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📋 Eligibility rules (as published)
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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What it tests

  • Pre-extubation continuous positive airway pressure
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Where

3 sites
The Royal Women's Hospital
Melbourne, Australia
The Royal Children's Hospital
Parkville, Australia
Joan Kirner Women's and Children's Hospital
Saint Albans, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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