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

NCT07251790 · tracked via the Priya Life Science Australia tracker

Sponsor

Murdoch Childrens Research Institute

Phase

Not applicable

Started

2026-05-04

Last updated

2026-08-26

Condition(s) studied

Respiratory Distress Syndrome, NewbornRespiratory Distress Syndrome in Premature Infant

Investigational drug(s) / intervention(s)

Pre-extubation continuous positive airway pressure

Pre-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.

Study 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

Sex

ALL

Min age

0 Hours

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (SF ratio) measured within 4 hours post-extubation, or until escalation to nasal intermittent positive pressure ventilation or re-intubation. — 0 minutes then each minute up to 15 minutes, then every 15 minutes up to 4 hours post-extubation.

Trial sites (3)

Facility	City	Region	Status
The Royal Women's Hospital	Melbourne	Victoria	Recruiting
The Royal Children's Hospital	Parkville	Victoria	Recruiting
Joan Kirner Women's and Children's Hospital	Saint Albans	Victoria	Recruiting

More Murdoch Childrens Research Institute trials in Australia

Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children Active, not recruiting

Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children Starting soon

Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2) Recruiting

Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course' Recruiting

Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation Recruiting

Other trials for the same condition

Speed of Lung Inflation During Ventilation of Extremely Preterm Infants Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07251790 on ClinicalTrials.gov ↗ ← All trials in Australia