Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorMurdoch Childrens Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-extubation continuous positive airway pressure
Procedure/SurgeryPrior 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.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Extubation with prePAPExperimental treatment 1 intervention
Group B: Extubation without prePAPNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
0 minutes then each minute up to 15 minutes, then every 15 minutes up to 4 hours post-extubation.Secondary outcomes
1
CPAP level set at extubation (0 minutes).
Time frame
Measured during the extubation procedure.2
Minimum CPAP level set post-extubation (0 minutes to 4 hours).
Time frame
Measured from extubation up to 4 hours post-extubation.3
Maximum CPAP level set post-extubation (0 minutes to 4 hours).
Time frame
Measured from extubation up to 4 hours post-extubation.4
Incidence of increase in CPAP level post-extubation (0 minutes to 4 hours).
Time frame
Completed for each participant at 4 hours post-extubation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Murdoch Childrens Research Institute
Lead sponsor
Western Health, Australia
Collaborator
Royal Women's Hospital, Melbourne, Australia
Collaborator
Source ClinicalTrials.gov