Actively Recruiting

Phase Not Applicable
Age: 0Hours +
All Genders
NCT07251790

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

Led by Murdoch Childrens Research Institute · Updated on 2026-05-07

134

Participants Needed

2

Research Sites

99 weeks

Total Duration

On this page

Sponsors

M

Murdoch Childrens Research Institute

Lead Sponsor

W

Western Health, Australia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Hours +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The infant is admitted to a participating neonatal intensive care unit (NICU)
  • The infant was born between 22 weeks 0 days and 29 weeks 6 days gestational age
  • The infant has been on invasive mechanical ventilation for at least 4 hours
  • The infant is being electively extubated for the first time from invasive ventilation to nasal continuous positive airway pressure (nCPAP)
  • The infant is clinically stable as determined by the clinical and research team
  • Parent(s) or legal guardian(s) provide informed consent
Not Eligible

You will not qualify if you...

  • The infant was born before 22 weeks or after 30 weeks gestational age
  • The infant has major congenital anomalies affecting the heart, lungs, or digestive system, or has a known genetic syndrome affecting respiratory outcomes
  • The infant has severe lung underdevelopment caused by low amniotic fluid before 22 weeks, expected to cause respiratory failure
  • The infant is receiving invasive ventilation through a nasotracheal tube
  • The infant is planned for extubation to any support other than nCPAP or no respiratory support
  • Parent(s) refuse informed consent or no guardian is available to provide consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The Royal Women's Hospital

Melbourne, Victoria, Australia, 3050

Not Yet Recruiting

2

Joan Kirner Women's and Children's Hospital

Saint Albans, Victoria, Australia, 3021

Actively Recruiting

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Research Team

G

Georgia S Stephen, BBmedSc BBiomedSc(Hons)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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