An interventional study of Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy and Control (Minimally Invasive Surfactant Therapy) in Surfactant Deficiency Syndrome Neonatal, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Treatment
Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant replacement therapy. Surfactant replacement therapy is an established therapy for the treatment of respiratory distress syndrome, which is a common illness in infants born preterm.
Surfactant replacement therapy can be delivered to an infant's lungs a few ways, including via a small tube that is briefly placed down an infant's throat. This is considered the least invasive method currently available, and is becoming more popular. It is referred to as minimally invasive surfactant therapy (MIST). A baby can receive surfactant via MIST if they are receiving non-invasive respiratory support, like from a continuous positive airway pressure (CPAP) machine.
Doctors and researchers are looking for simple ways to make MIST more effective. This clinical trial will investigate if briefly increasing the air pressure delivered by a CPAP machine before giving MIST therapy will make MIST more effective. This strategy is called a lung recruitment manoeuvre (LRM), because it opens up more of the lungs - 'recruits' them - to help with oxygenation. The CPAP setting that is briefly changed is called positive end expiratory pressure (PEEP) - it increases the amount of air left in the lungs at the end of a breath. This stops parts of the lung collapsing when exhaling, which commonly occurs in the lungs of infants born preterm as they are immature.
The goal of this clinical trial is to investigate if a LRM prior to MIST improves ventilation and lung aeration in preterm infants born 24-32 weeks' gestation. The main question it aims to answer is: How a LRM prior to MIST might impact patterns of ventilation and lung aeration in preterm infants, compared to no LRM prior to MIST.
The current standard of care is no LRM before MIST. Researchers will compare this current standard against a LRM before MIST to see if it potentially improves patterns of ventilation.
Participants will be randomly placed (by chance) to receive either no LRM before MIST (control) or a LRM before MIST (intervention). Participants will be randomised once their treating clinical team have decided to give MIST.
Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like exogenous surfactant. Exogenous surfactant is an established therapy for the treatment of respiratory distress syndrome and may reduce the risk of an infant developing bronchopulmonary dysplasia.
Exogenous surfactant therapy can be administered via an endotracheal tube which is either permanent, or transiently placed, but can now also be administered via less-invasive techniques. Minimally Invasive Surfactant Therapy (MIST) uses a thin catheter that is passed through the vocal cords to deliver exogenous surfactant directly into the lungs when an infant is on non-invasive respiratory support. MIST is becoming increasing popular in neonatal practice as more infants are managed on non-invasive respiratory support, and it is considered lower-risk compared to techniques that transiently place an endotracheal tube for surfactant therapy as there is no risk of extubation failure.
To further improve surfactant therapy, optimisations of delivery techniques have been explored. One optimisation that has been investigated with the transient endotracheal tube method of delivery surfactant is adding a lung recruitment manoeuvre (LRM) prior to surfactant delivery. This demonstrated a reduced need for mechanical ventilation within 72 hours following a LRM compared to infants which did not receive the LRM before surfactant via a transient endotracheal tube. By adding a lung recruitment component to MIST, the benefits of this more invasive method may be replicated without increasing risk of extubation failure.
deMISTify is a blinded, randomised, controlled trial of preterm infants, 24-32 weeks' gestation, receiving continuous positive airway pressure (CPAP) respiratory support and MIST. The primary aim of the study is to investigate the impact of a LRM prior to MIST on the mean ventro-dorsal centre of ventilation. Infants will receive a transient increase in CPAP Positive End-Expiratory Pressure (PEEP) levels, known as a LRM, prior to the administration of MIST. Infants who do not receive a LRM will act as the control group. The primary outcome will be change in centre of ventilation (ventro-dorsal) from a pre-MIST baseline as a measure of air distribution in the lungs, 1 hour after MIST, assessed using electrical impedance tomography (EIT).
Arm 1: Control - Patients randomised to Control will receive no LRM prior to MIST and no changes to baseline PEEP will be made. In all participating sites the standard PEEP level during CPAP is 7-8 cmH2O.
Arm 2: Intervention
- PEEP will be transiently increased to 10 cmH2O 20 minutes before MIST is scheduled to occur. PEEP will remain at this setting for the duration of MIST. Following MIST, PEEP will be decreased to baseline.
377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis 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.
Minimally Invasive Surfactant Therapy (as per unit protocol)
Device: Control (Minimally Invasive Surfactant Therapy)
Lung recruitment manoeuvre prior to minimally invasive surfactant therapy. CPAP PEEP is increased from 7-8 cmH2O to 10 cmH2O in one step for 20 mins prior to MIST. PEEP will be decreased to 7-8 cmH2O after surfactant administration.
Device: Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy
Lung recruitment manoeuvre prior to minimally invasive surfactant therapy. CPAP PEEP is increased from 7-8 cmH2O to 10 cmH2O in one step for 20 mins prior to MIST. PEEP will be decreased to 7-8 cmH2O after surfactant administration.
Also known as: Lung Recruitment Manoeuvre
Minimally Invasive Surfactant Therapy (MIST) as per unit protocol
Also known as: Minimally Invasive Surfactant Therapy
Mean Change in the Centre of Ventilation (ventro-dorsal)
An electrical impedance tomography-based measure, this is a measure of the homogeneity of air distribution in the lungs along the ventral to dorsal axis. A baseline measurement will be taken pre-MIST occurring. A final measurement will be taken 60 minutes after MIST has occurred. The difference between these values will be compared as the primary outcome measure.
Time frame: Baseline, 60 minutes
Number of total surfactant doses
Time frame: From date of randomisation until date of discharge from primary Neonatal Intensive Care Unit, or date of death from any cause, whichever occurs first, assessed up to 12 months
Need for intubation within 72 hours of MIST
Yes / No response
Time frame: 72 hours
FiO2 % 24 hours after MIST
FiO2 %
Time frame: 24 hours
Number of days on respiratory support
Time frame: From date of randomisation until date of discharge from primary Neonatal Intensive Care Unit, or date of death from any cause, whichever occurs first, assessed up to 12 months
Incidence of air leak
As per diagnosis by treating clinical team. If a participant experiences air leak, the time and date will be recorded for each incident.
Time frame: From date of randomisation until date of discharge from primary Neonatal Intensive Care Unit, or date of death from any cause, whichever occurs first, assessed up to 12 months
Plan to share: No — All individual participant data collected during the trial, after de-identification and publication of primary results will be available 6-months after publication upon request. Proposals should be directed to david.tingay@mcri.edu.au and/or mctc@mcri.edu.au to gain access. Data requestors will need to sign a data access or material transfer agreement approved by the Murdoch Children's Research Institute.
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.
Murdoch Childrens Research Institute