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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
The Royal Women's Hospital
RECRUITING
Melbourne
Joan Kirner Women's and Children's Hospital
RECRUITING
Saint Albans
Contact Information
Primary
Georgia S Stephen, BBmedSc BBiomedSc(Hons)
georgia.stephen@mcri.edu.au
424701924
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 134
Treatments
Experimental: Extubation with prePAP
nCPAP commenced prior to endotracheal tube removal
No_intervention: Extubation without prePAP
nCPAP commenced following endotracheal tube removal
Sponsors
Collaborators: Royal Women's Hospital, Melbourne, Australia, Western Health, Australia
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov

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