Surfactant Deficiency Syndrome NeonataldeMISTifyNCT07522346
deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants
A study testing Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy in people with Surfactant Deficiency Syndrome Neonatal, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Surfactant Deficiency Syndrome Neonatal
- What is being tested?
- Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Aug 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born between 24 to 31+6 weeks' gestation, by best obstetric estimate
- Admitted to a participating NICU
- A parent/guardian who can provide informed consent
- Receiving CPAP respiratory support
- Planned to receive MIST by clinicians as standard clinical care
- Clinically stable (as determined by clinical team)
- Infant less than 72 hours of age
- MIST can be administered within 90 min of allocating assigned interventional arm
Who cannot join
- Receiving any form of respiratory support other than CPAP
- Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth)
- The infant's clinical team has concern regarding clinical stability and tolerability of EIT
- The infant's skin integrity will not tolerate the EIT belt and gel
- Refusal of informed consent by their parent/guardian/legally acceptable representative
- The infant does not have a parent/guardian who can provide informed consent.
Show all 12Show fewer
- Major congenital anomaly involving the cardiac, respiratory, gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes
- Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 24 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early post-natal life
- Suspected or confirmed air leak or pneumothorax
- Previous treatment with surfactant or mechanical ventilation via an endotracheal tube
- Urgent need for intubation and mechanical ventilation as determined by the treating clinician
- Not receiving full active intensive care (i.e. palliative/comfort care)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Joan Kirner Women's and Children's Hospital
Saint Albans, Victoria, 3021
Arun Sett, Doctor, +61 8345 1333, arun.sett@wh.org.au
About this study
Official title: deMISTify: The Impact of CPAP Levels During Minimally Invasive Surfactant Therapy on Regional Patterns of Ventilation in Preterm Infants
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Surfactant Deficiency Syndrome Neonatal
- Being tested
- Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy, Control (Minimally Invasive Surfactant Therapy)
- Keywords
- Minimally Invasive Surfactant Therapy, Lung Recruitment Manoeuvre, Electrical Impedance Tomography
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant TherapyDevice
Also called Lung Recruitment Manoeuvre
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.
Control (Minimally Invasive Surfactant Therapy)Device
Also called Minimally Invasive Surfactant Therapy
Minimally Invasive Surfactant Therapy (MIST) as per unit protocol
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Minimally Invasive Surfactant Therapy (as per unit protocol) Receives: Device: Control (Minimally Invasive Surfactant Therapy) |
| Intervention | Experimental | 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. Receives: Device: Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 60 minutes
Secondary outcomes (5)
Number of total surfactant doses
Measured: 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
Measured: 72 hours
FiO2 % 24 hours after MIST
FiO2 %
Measured: 24 hours
Number of days on respiratory support
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start18 Aug 2026
- Primary completionNov 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surfactant Deficiency Syndrome NeonatalStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Tingay, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522346
- Sponsor's protocol ID
- 123038
- Acronym
- deMISTify
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kidman AM, Manley BJ, Boland RA, Malhotra A, Donath SM, Beker F, Davis PG, Bhatia R. Higher versus lower nasal continuous positive airway pressure for extubation of extremely preterm infants in Australia (ECLAT): a multicentre, randomised, superiority trial. Lancet Child Adolesc Health. 2023 Dec;7(12):844-851. doi: 10.1016/S2352-4642(23)00235-3. Epub 2023 Oct 27.
PubMed 38240784Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.
PubMed 34902013Vento G, Ventura ML, Pastorino R, van Kaam AH, Carnielli V, Cools F, Dani C, Mosca F, Polglase G, Tagliabue P, Boni L, Cota F, Tana M, Tirone C, Aurilia C, Lio A, Costa S, D'Andrea V, Lucente M, Nigro G, Giordano L, Roma V, Villani PE, Fusco FP, Fasolato V, Colnaghi MR, Matassa PG, Vendettuoli V, Poggi C, Del Vecchio A, Petrillo F, Betta P, Mattia C, Garani G, Solinas A, Gitto E, Salvo V, Gargano G, Balestri E, Sandri F, Mescoli G, Martinelli S, Ilardi L, Ciarmoli E, Di Fabio S, Maranella E, Grassia C, Ausanio G, Rossi V, Motta A, Tina LG, Maiolo K, Nobile S, Messner H, Staffler A, Ferrero F, Stasi I, Pieragostini L, Mondello I, Haass C, Consigli C, Vedovato S, Grison A, Maffei G, Presta G, Perniola R, Vitaliti M, Re MP, De Curtis M, Cardilli V, Lago P, Tormena F, Orfeo L, Gizzi C, Massenzi L, Gazzolo D, Strozzi MCM, Bottino R, Pontiggia F, Berardi A, Guidotti I, Cacace C, Meli V, Quartulli L, Scorrano A, Casati A, Grappone L, Pillow JJ. Lung recruitment before surfactant administration in extremely preterm neonates with respiratory distress syndrome (IN-REC-SUR-E): a randomised, unblinded, controlled trial. Lancet Respir Med. 2021 Feb;9(2):159-166. doi: 10.1016/S2213-2600(20)30179-X. Epub 2020 Jul 17.
PubMed 32687801
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- deMISTify: The Impact of CPAP Levels During Minimally Invasive Surfactant Therapy on Regional Patterns of Ventilation in Preterm Infants
- ClinicalTrials.gov ID
- NCT07522346
- Acronym / sponsor ID
- deMISTify / 123038
- Conditions
- Surfactant Deficiency Syndrome Neonatal
- Keywords
- Minimally Invasive Surfactant Therapy, Lung Recruitment Manoeuvre, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Control (Minimally Invasive Surfactant Therapy)Minimally Invasive Surfactant Therapy (as per unit protocol) |
| Intervention | Experimental | Device: Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant TherapyLung 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. |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Born between 24 to 31+6 weeks' gestation, by best obstetric estimate
- Admitted to a participating NICU
- A parent/guardian who can provide informed consent
- Receiving CPAP respiratory support
- Planned to receive MIST by clinicians as standard clinical care
Key exclusion criteria (12 listed)
- Receiving any form of respiratory support other than CPAP
- Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth)
- The infant's clinical team has concern regarding clinical stability and tolerability of EIT
- The infant's skin integrity will not tolerate the EIT belt and gel
- Refusal of informed consent by their parent/guardian/legally acceptable representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant TherapyAlso: Lung Recruitment ManoeuvreLung 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 | Intervention |
| Control (Minimally Invasive Surfactant Therapy)Also: Minimally Invasive Surfactant TherapyMinimally Invasive Surfactant Therapy (MIST) as per unit protocol | Device | Control |
Primary outcome
Mean Change in the Centre of Ventilation (ventro-dorsal)
Time frame: Baseline, 60 minutes
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.
5 secondary outcomes
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
Time frame: 72 hours
FiO2 % 24 hours after MIST
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 38240784Kidman AM, Manley BJ, Boland RA, Malhotra A, Donath SM, Beker F, Davis PG, Bhatia R. Higher versus lower nasal continuous positive airway pressure for extubation of extremely preterm infants in Australia (ECLAT): a multicentre, randomised, superiority trial. Lancet Child Adolesc Health. 2023 Dec;7(12):844-851. doi: 10.1016/S2352-4642(23)00235-3. Epub 2023 Oct 27.
- Background: PubMed 34902013Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.
- Background: PubMed 32687801Vento G, Ventura ML, Pastorino R, van Kaam AH, Carnielli V, Cools F, Dani C, Mosca F, Polglase G, Tagliabue P, Boni L, Cota F, Tana M, Tirone C, Aurilia C, Lio A, Costa S, D'Andrea V, Lucente M, Nigro G, Giordano L, Roma V, Villani PE, Fusco FP, Fasolato V, Colnaghi MR, Matassa PG, Vendettuoli V, Poggi C, Del Vecchio A, Petrillo F, Betta P, Mattia C, Garani G, Solinas A, Gitto E, Salvo V, Gargano G, Balestri E, Sandri F, Mescoli G, Martinelli S, Ilardi L, Ciarmoli E, Di Fabio S, Maranella E, Grassia C, Ausanio G, Rossi V, Motta A, Tina LG, Maiolo K, Nobile S, Messner H, Staffler A, Ferrero F, Stasi I, Pieragostini L, Mondello I, Haass C, Consigli C, Vedovato S, Grison A, Maffei G, Presta G, Perniola R, Vitaliti M, Re MP, De Curtis M, Cardilli V, Lago P, Tormena F, Orfeo L, Gizzi C, Massenzi L, Gazzolo D, Strozzi MCM, Bottino R, Pontiggia F, Berardi A, Guidotti I, Cacace C, Meli V, Quartulli L, Scorrano A, Casati A, Grappone L, Pillow JJ. Lung recruitment before surfactant administration in extremely preterm neonates with respiratory distress syndrome (IN-REC-SUR-E): a randomised, unblinded, controlled trial. Lancet Respir Med. 2021 Feb;9(2):159-166. doi: 10.1016/S2213-2600(20)30179-X. Epub 2020 Jul 17.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Tingay principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy in people with Surfactant Deficiency Syndrome Neonatal, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederique N Donnelly (+61 8341 6200, frederique.donnelly@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in the Centre of Ventilation (ventro-dorsal) (time frame: Baseline, 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.