RecruitingNot ApplicableNCT07251790

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

PrePAP: Pre-Extubation Continuous Positive Airway Pressure in Very Preterm Infants: A Randomised Controlled Trial


Sponsor

Murdoch Childrens Research Institute

Enrollment

134 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 Hours

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Pre-extubation continuous positive airway pressure for people with respiratory distress syndrome in premature infant and respiratory distress syndrome, newborn. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPre-extubation continuous positive airway pressure

Prior to extubation (2-to-5 minutes) a CPAP hat will be placed on the infant and the circuit set up. A nasal mask will be applied and nCPAP pressure will be commenced at 10 centimetres of water. Only after nCPAP has been in situ for 2 minutes (maximum 5 minutes) will the endotracheal tube be removed.


Locations(3)

The Royal Women's Hospital

Melbourne, Victoria, Australia

The Royal Children's Hospital

Parkville, Victoria, Australia

Joan Kirner Women's and Children's Hospital

Saint Albans, Victoria, Australia

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NCT07251790


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