NCT07251790 Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
| NCT ID | NCT07251790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Respiratory Distress Syndrome, Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2026-05-04 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility 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.
Contact & Investigator
Georgia S Stephen, BBmedSc BBiomedSc(Hons)
PRINCIPAL INVESTIGATOR
Murdoch Childrens Research Institute
Frequently Asked Questions
Who can join the NCT07251790 clinical trial?
This trial is open to participants of all sexes, aged 0 Hours or older, studying Respiratory Distress Syndrome, Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07251790 currently recruiting?
Yes, NCT07251790 is actively recruiting participants. Contact the research team at georgia.stephen@mcri.edu.au for enrollment information.
Where is the NCT07251790 trial being conducted?
This trial is being conducted at Melbourne, Australia, Saint Albans, Australia.
Who is sponsoring the NCT07251790 clinical trial?
NCT07251790 is sponsored by Murdoch Childrens Research Institute. The principal investigator is Georgia S Stephen, BBmedSc BBiomedSc(Hons) at Murdoch Childrens Research Institute. The trial plans to enroll 134 participants.