An interventional study of Pre-extubation continuous positive airway pressure in Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, sponsored by Murdoch Childrens Research Institute. Recruiting at 3 sites in Australia. Open to participants aged 0 Hours and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Supportive care
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?
The PrePAP trial will investigate if extubation with prePAP (nCPAP commenced prior to extubation) compared to standard extubation practice (nCPAP commenced after extubation) reduces oxygen desaturation in the four hours immediately post-extubation, in very preterm infants being extubated for the first time within the first 30 days of life.
Many infants born very preterm (\<32 weeks' gestation) are intubated at birth to receive respiratory support via invasive ventilation. While essential for survival, invasive ventilation can injure their underdeveloped lungs, disrupt lung development and increase the risk of bronchopulmonary dysplasia, a major cause of long-term respiratory morbidity.
Transitioning infants to non-invasive ventilation as soon as feasible is prioritised by clinicians. However, in very preterm infants, almost 40% of extubation attempts fail due to oxygen desaturation or lung collapse. Re-intubation due to extubation failure can induce further airway injury, cardiovascular instability, and oxygen desaturation, resulting in clinical deterioration and prolonged hospitalisation.
PrePAP has been recently suggested as a method of improving respiratory stability during extubation in preterm infants. PrePAP involves commencing nCPAP prior to extubation, with the intent to maintain lung volumes during extubation; preserving oxygenation from pre- to post-extubation. To date, there isn't any clinical evidence explaining the impact to the lungs when both mechanical ventilation and nCPAP are being applied, nor is there evidence that signals a benefit of using prePAP during extubation. Despite this, prePAP is already used in clinical practice and is described in certain neonatal intensive care unit (NICU) extubation guidelines in Australia.
The PrePAP trial is a prospective, multicentre, unblinded, randomised, controlled trial comparing extubation from mechanical ventilation to nCPAP with and without the application of prePAP in very preterm infants born \<30 weeks gestational age at first extubation.
Very preterm infants who meet all inclusion (and no exclusion) criteria will be randomised to receive one of two extubation procedures, placing them in either the "Extubation with prePAP" arm or the "Extubation without prePAP" arm:
For both arms, the intervention period will begin with a 2-to-5-minute pre-extubation period (whilst the infant is still ventilated), followed by a post-extubation period of up to 4 hours, and a follow-up period of up to 7 days (168 hours). The primary outcome (lowest S/F ratio) is assessed only during the (up to) 4-hour post-extubation period.
The results of this trial will determine the appropriate clinical outcomes and end point for a definitive, larger randomised trial to inform clinical practice.
123 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 24 are open to participants now.
This study's planned enrollment of 134 is above the median of 90 across 93 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
nCPAP commenced prior to endotracheal tube removal
Procedure: Pre-extubation continuous positive airway pressure
nCPAP commenced following endotracheal tube removal
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.
Also known as: PrePAP
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.
CPAP level set at extubation (0 minutes).
Time frame: Measured during the extubation procedure.
Minimum CPAP level set post-extubation (0 minutes to 4 hours).
Time frame: Measured from extubation up to 4 hours post-extubation.
Maximum CPAP level set post-extubation (0 minutes to 4 hours).
Time frame: Measured from extubation up to 4 hours post-extubation.
Incidence of increase in CPAP level post-extubation (0 minutes to 4 hours).
Time frame: Completed for each participant at 4 hours post-extubation.
Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (SF ratio) measured pre-extubation and within 4 hours post-extubation (-5 minutes to 4 hours).
Time frame: Measured from 5 minutes pre-extubation up to 4 hours post-extubation.
Change in peripheral oxygen saturation (SpO2) measured pre-extubation and within 4 hours post-extubation (-5 minutes to 4 hours).
Time frame: Measured from 5 minutes pre-extubation up to 4 hours post-extubation.
Change in fraction of inspired oxygen (FiO2) measured pre-extubation and within 4 hours post-extubation (-5 minutes to 4 hours).
Time frame: Measured from 5 minutes pre-extubation up to 4 hours post-extubation.
Maximum fraction of inspired oxygen (FiO2) measured pre-extubation and within 4 hours post-extubation (-5 minutes to 4 hours).
Time frame: Measured from 5 minutes pre-extubation up to 4 hours post-extubation.
Change in incidence of significant oxygen desaturation measured post-extubation (0 minutes to 4 hours).
Significant oxygen desaturation is defined as SpO2 \<80% for \>30 seconds
Time frame: Measured from extubation up to 4 hours post-extubation.
Incidence of escalation to nasal intermittent positive pressure ventilation within 7 days post-extubation.
Time frame: Completed for each participant at the end of their study period: 7 days post-extubation.
Incidence of re-intubation within 7 days post-extubation.
Time frame: Completed for each participant at the end of their study period: 7 days post-extubation.
Plan to share: Yes — The de-identified data set collected for this analysis of the PrePAP trial will be available six months after publication of the primary outcome, if the below access criteria are met. The study protocol, statistical analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute (MCRI) by emailing georgia.stephen@mcri.edu.au, david.tingay@rch.org.au and mctc@mcri.edu.au.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 6 months after publication of primary outcome.
Access criteria: Prior to releasing any data the following are required: A Data Transfer Agreement must be signed between relevant parties. The MCRI Sponsorship Committee must review and approve your protocol and statistical analysis plan which must include and describe how the data will be used and analysed. An Authorship Agreement to be agreed to and signed between relevant parties. The Agreement must include details regarding appropriate recognition. Authorship may not be justifiable but some form of acknowledgement is requested. Agreement to cover any additional costs relating to the provision of the data. Evidence of ethics approval or waiver of approval, to be compliant with the data transfer agreement and ethics requirements at our end. Data will only be shared with a recognised research institution where the MCRI Sponsorship Committee has approved the proposed analysis plan.
Data sharing details ↗ · www.mcri.edu.au
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Distress Syndrome, Newborn →
Murdoch Childrens Research Institute