Respiratory Distress Syndrome, NewbornFLOW-VENTNCT07101419
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
A study testing Long PRT and Short PRT in people with Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, run by Murdoch Childrens Research Institute at 3 sites in Australia.
Trial summary
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. Read more about this study
- Who is it for?
- Ages 6 hours to 7 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Long PRT and Short PRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesAustralia
- Study dates
- Feb 2027to Feb 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 6 hours to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to participating neonatal intensive care unit
- Born between 22+0 to 27+6 weeks' gestation
- Current weight ≥400 grams
- Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee [PC-AC+VG] mode on Dräger Babylog VN500/800 ventilators) initiated within 72-hours post birth
- Postnatal age ≥6 hours and ≤7 days
- Received surfactant therapy
- Clinically stable (as per treating and research team consensus)
- Parent(s)/legal guardian provides prospective informed consent.
Who cannot join
- Major congenital anomaly involving the cardiac, respiratory or 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 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life
- Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation
- Planned for extubation from mechanical ventilation within the next 12 hours.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
Mercy Hospital for Women
Heidelberg, Victoria
Brett Manley, MBBS(Hons) FRACP PhD, 61384584444, brett.manley@unimelb.edu.au
Kristin Ferguson, BSc MBBS, kristin.ferguson@mcri.edu.au
The Royal Women's Hospital
Parkville, Victoria, 3051
Kate Hodgson, BMSc MBBS(Hons) PhD, 61383452000, kate.hodgson@thewomens.org.au
Kristin Ferguson, BSc MBBS, kristin.ferguson@mcri.edu.au
Joan Kirner Women's and Children's Hospital
Saint Albans, Victoria, 3021
Arun Sett, MBBS(Hons) FRACP PhD, 61383451333, arun.sett@wh.org.au
About this study
Official title: Longer Pressure Rise Time During Mechanical Ventilation of Extremely Preterm Infants: A Randomised Crossover Trial
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems.
This clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment.
Read more
This study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs).
The main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?
Read the detailed description
The FLOW-VENT trial will investigate if using a long pressure rise time (PRT; thereby reducing the speed of gas flow) compared to a short PRT, during synchronised, patient-triggered, volume-targeted conventional mechanical ventilation in extremely preterm infants within the first postnatal week impacts an infant's oxygenation.
All infants born extremely preterm (<28 weeks' gestation) require breathing support to survive. However, this support can damage their lungs. Rates of bronchopulmonary dysplasia (BPD), the chronic lung disease of extreme prematurity, are increasing. This is despite 'lung protective' respiratory support and ventilation strategies that aim to minimise harm to the preterm lung.
Pre-clinical evidence suggests that gas flows lower than currently used during respiratory support of these infants may be a major, and easily modifiable way of reducing preterm lung injury (Tingay 2024; Bach 2012). Current guidelines lack evidence for suggested gas flow settings. Many ventilators now modulate ventilator gas flows by a setting known as pressure rise time (PRT).
FLOW-VENT is a prospective, multicentre, unblinded, randomised crossover trial enrolling 68 extremely preterm infants born <28 weeks gestational age. A long PRT is defined as a PRT set at 75% of the inspiratory time (Ti). A short PRT is defined as a PRT set at 33% of the Ti.
Given the crossover design, infants will receive both the long and short PRT setting. Extremely preterm infants will be randomised to a 'sequence' which will determine the order in which they are exposed to the different PRTs; either:
- Long-Short PRT Sequence: Long PRT in the first treatment period and Short PRT in the second treatment period, OR
- Short-Long PRT Sequence: Short PRT in the first treatment period and Long PRT in the second treatment period.
The trial crossover phase (~10-12 hours) consists of: 1) Preparatory washout period (1 to 2 hours); 2) First treatment period (4-hours); 3) Washout period (1 to 2 hours); 4) Second treatment period (4-hours). Following this, there is a 12-hour follow-up period to monitor for adverse/safety events. The primary outcome (average S/F ratio) is assessed only during the 4-hour treatment periods.
Results from this trial will inform the decision to proceed to a larger randomised trial, powered for longer term respiratory outcomes (e.g. time to extubation from mechanical ventilation, BPD at 36 weeks' postmenstrual age).
- Being tested
- Long PRT, Short PRT
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long PRTOther
Also called Long Pressure Rise Time
PRT (in seconds) set at 75% of inspiratory time (in seconds)
Short PRTOther
Also called Short Pressure Rise Time
PRT (in seconds) set at 33% of inspiratory time (in seconds).
| Study group | Role | What they receive |
|---|---|---|
| Long-Short PRT Sequence | Experimental | Long PRT set during first treatment period; Short PRT set during second treatment period Receives: Other: Long PRT; Other: Short PRT |
| Short-Long PRT Sequence | Experimental | Short PRT set during first treatment period; Long PRT set during second treatment period Receives: Other: Long PRT; Other: Short PRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (S/F Ratio) measured each minute during each treatment period (0 minutes to 4 hours)
Measured: 0 minutes then each minute up to 4 hours for each of the Long PRT and Short PRT 4-hour treatment periods
Secondary outcomes (19)
Change in pressure rise time (PRT) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in mean airway pressure (MAP) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during of the Long PRT and Short PRT 4-hour treatment periods.
Change in positive end expiratory pressure (PEEP) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in peak inspiratory pressure (PIP) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in tidal volume (VT) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in respiratory rate measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in minute ventilation measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in endotracheal tube leak measured each minute during each treatment period (0 minutes to 4 hours)
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in inspiratory time (Ti) measured each minute during each treatment period (0 minutes to 4 hours)
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in inspiratory gas flows measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in peripheral oxygen saturation (SpO2) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in fraction of inspired oxygen (FiO2) measured each minute during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in incidence of significant oxygen desaturation measured during each treatment period (0 minutes to 4 hours).
Significant oxygen desaturation is defined as SpO2 <80% for >30 seconds
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in total number FiO2 changes measured during each treatment period (0 minutes to 4 hours).
Measured: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Incidence of air leak (pneumothorax or pneumomediastinum)
Measured: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of pulmonary haemorrhage receiving management (increased PEEP/PIP/FiO2 or blood products)
Measured: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of resuscitation (defined as receiving external cardiac compressions or adrenaline boluses)
Measured: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of death
Measured: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of treating consultant request to discontinue randomly allocated PRT prematurely
Measured: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Crossover
- Model description
- Extremely preterm infants on synchronised, patient-triggered, volume targeted conventional mechanical ventilation are managed with each pressure rise time (PRT) setting for 4 hours (treatment period 1), prior to crossing over to the other PRT setting for a further 4 hours (treatment period 2). There will be a 1-2 hour preparatory washout phase prior to treatment period 1 and another 1-2 hour washout between treatment period 1 and 2. Infants will be monitored for a further 12-hours post-completion of the crossover trial for safety events.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Hospital for Women, Australia, Royal Women's Hospital, Melbourne, Australia, Western Health, Australia
- Responsible party
- Sponsor
- Investigators
- Kristin N Ferguson, BSc MBBS, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101419
- Sponsor's protocol ID
- 117784
- Acronym
- FLOW-VENT
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for this analysis of the FLOW-VENT 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 kristin.ferguson@mcri.edu.au, david.tingay@rch.org.au and mctc@mcri.edu.au.
Publications
Tingay DG, Fatmous M, Kenna K, Chapman J, Douglas E, Sett A, Poh QH, Dahm SI, Quach TK, Sourial M, Fang H, Greening DW, Pereira-Fantini PM. Speed of lung inflation at birth influences the initiation of lung injury in preterm lambs. JCI Insight. 2024 Aug 6;9(18):e181228. doi: 10.1172/jci.insight.181228.
PubMed 39106107Bach KP, Kuschel CA, Patterson N, Skwish H, Huth S, Phua HH, Bloomfield FH. Effect of Bias Gas Flow on Tracheal Cytokine Concentrations in Ventilated Extremely Preterm Infants: A Randomized Controlled Trial. Neonatology. 2021;118(3):332-339. doi: 10.1159/000515364. Epub 2021 Apr 7.
PubMed 33827091Bach KP, Kuschel CA, Oliver MH, Bloomfield FH. Ventilator gas flow rates affect inspiratory time and ventilator efficiency index in term lambs. Neonatology. 2009;96(4):259-64. doi: 10.1159/000220765. Epub 2009 May 27.
PubMed 19478530Bach KP, Kuschel CA, Hooper SB, Bertram J, McKnight S, Peachey SE, Zahra VA, Flecknoe SJ, Oliver MH, Wallace MJ, Bloomfield FH. High bias gas flows increase lung injury in the ventilated preterm lamb. PLoS One. 2012;7(10):e47044. doi: 10.1371/journal.pone.0047044. Epub 2012 Oct 8.
PubMed 23056572Chong D, Kayser S, Szakmar E, Morley CJ, Belteki G. Effect of pressure rise time on ventilator parameters and gas exchange during neonatal ventilation. Pediatr Pulmonol. 2020 May;55(5):1131-1138. doi: 10.1002/ppul.24724. Epub 2020 Mar 9.
PubMed 32150670
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longer Pressure Rise Time During Mechanical Ventilation of Extremely Preterm Infants: A Randomised Crossover Trial
- ClinicalTrials.gov ID
- NCT07101419
- Acronym / sponsor ID
- FLOW-VENT / 117784
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Mercy Hospital for Women, Australia, Royal Women's Hospital, Melbourne, Australia, Western Health, Australia
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 Aug 2025 (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.
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems.
This clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment.
This study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs).
The main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?
Detailed description
The FLOW-VENT trial will investigate if using a long pressure rise time (PRT; thereby reducing the speed of gas flow) compared to a short PRT, during synchronised, patient-triggered, volume-targeted conventional mechanical ventilation in extremely preterm infants within the first postnatal week impacts an infant's oxygenation.
All infants born extremely preterm (<28 weeks' gestation) require breathing support to survive. However, this support can damage their lungs. Rates of bronchopulmonary dysplasia (BPD), the chronic lung disease of extreme prematurity, are increasing. This is despite 'lung protective' respiratory support and ventilation strategies that aim to minimise harm to the preterm lung.
Pre-clinical evidence suggests that gas flows lower than currently used during respiratory support of these infants may be a major, and easily modifiable way of reducing preterm lung injury (Tingay 2024; Bach 2012). Current guidelines lack evidence for suggested gas flow settings. Many ventilators now modulate ventilator gas flows by a setting known as pressure rise time (PRT).
FLOW-VENT is a prospective, multicentre, unblinded, randomised crossover trial enrolling 68 extremely preterm infants born <28 weeks gestational age. A long PRT is defined as a PRT set at 75% of the inspiratory time (Ti). A short PRT is defined as a PRT set at 33% of the Ti.
Given the crossover design, infants will receive both the long and short PRT setting. Extremely preterm infants will be randomised to a 'sequence' which will determine the order in which they are exposed to the different PRTs; either:
- Long-Short PRT Sequence: Long PRT in the first treatment period and Short PRT in the second treatment period, OR
- Short-Long PRT Sequence: Short PRT in the first treatment period and Long PRT in the second treatment period.
The trial crossover phase (~10-12 hours) consists of: 1) Preparatory washout period (1 to 2 hours); 2) First treatment period (4-hours); 3) Washout period (1 to 2 hours); 4) Second treatment period (4-hours). Following this, there is a 12-hour follow-up period to monitor for adverse/safety events. The primary outcome (average S/F ratio) is assessed only during the 4-hour treatment periods.
Results from this trial will inform the decision to proceed to a larger randomised trial, powered for longer term respiratory outcomes (e.g. time to extubation from mechanical ventilation, BPD at 36 weeks' postmenstrual age).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Extremely preterm infants on synchronised, patient-triggered, volume targeted conventional mechanical ventilation are managed with each pressure rise time (PRT) setting for 4 hours (treatment period 1), prior to crossing over to the other PRT setting for a further 4 hours (treatment period 2). There will be a 1-2 hour preparatory washout phase prior to treatment period 1 and another 1-2 hour washout between treatment period 1 and 2. Infants will be monitored for a further 12-hours post-completion of the crossover trial for safety events.
| Arm | Type | Receives |
|---|---|---|
| Long-Short PRT Sequence | Experimental | Other: Long PRT, Other: Short PRTLong PRT set during first treatment period; Short PRT set during second treatment period |
| Short-Long PRT Sequence | Experimental | Other: Long PRT, Other: Short PRTShort PRT set during first treatment period; Long PRT set during second treatment period |
Who may qualify
- Ages
- 6 hours to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Admitted to participating neonatal intensive care unit
- Born between 22+0 to 27+6 weeks' gestation
- Current weight ≥400 grams
- Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee [PC-AC+VG] mode on Dräger Babylog VN500/800 ventilators) initiated within 72-hours post birth
- Postnatal age ≥6 hours and ≤7 days
Key exclusion criteria (4 listed)
- Major congenital anomaly involving the cardiac, respiratory or 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 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life
- Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation
- Planned for extubation from mechanical ventilation within the next 12 hours.
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 |
|---|---|---|
| Long PRTAlso: Long Pressure Rise TimePRT (in seconds) set at 75% of inspiratory time (in seconds) | Other | Long-Short PRT Sequence, Short-Long PRT Sequence |
| Short PRTAlso: Short Pressure Rise TimePRT (in seconds) set at 33% of inspiratory time (in seconds). | Other | Long-Short PRT Sequence, Short-Long PRT Sequence |
Primary outcome
Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (S/F Ratio) measured each minute during each treatment period (0 minutes to 4 hours)
Time frame: 0 minutes then each minute up to 4 hours for each of the Long PRT and Short PRT 4-hour treatment periods
19 secondary outcomes
Change in pressure rise time (PRT) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in mean airway pressure (MAP) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during of the Long PRT and Short PRT 4-hour treatment periods.
Change in positive end expiratory pressure (PEEP) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in peak inspiratory pressure (PIP) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in tidal volume (VT) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in respiratory rate measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in minute ventilation measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in endotracheal tube leak measured each minute during each treatment period (0 minutes to 4 hours)
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in inspiratory time (Ti) measured each minute during each treatment period (0 minutes to 4 hours)
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in inspiratory gas flows measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in peripheral oxygen saturation (SpO2) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in fraction of inspired oxygen (FiO2) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in incidence of significant oxygen desaturation measured during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Change in total number FiO2 changes measured during each treatment period (0 minutes to 4 hours).
Time frame: Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Incidence of air leak (pneumothorax or pneumomediastinum)
Time frame: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of pulmonary haemorrhage receiving management (increased PEEP/PIP/FiO2 or blood products)
Time frame: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of resuscitation (defined as receiving external cardiac compressions or adrenaline boluses)
Time frame: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of death
Time frame: Completed for each participant at end of their study period: 22-24 hours from study commencement.
Incidence of treating consultant request to discontinue randomly allocated PRT prematurely
Time frame: Completed for each participant at end of their study period: 22-24 hours from study commencement.
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 24 Jun 2026.
- Background: PubMed 39106107Tingay DG, Fatmous M, Kenna K, Chapman J, Douglas E, Sett A, Poh QH, Dahm SI, Quach TK, Sourial M, Fang H, Greening DW, Pereira-Fantini PM. Speed of lung inflation at birth influences the initiation of lung injury in preterm lambs. JCI Insight. 2024 Aug 6;9(18):e181228. doi: 10.1172/jci.insight.181228.
- Background: PubMed 33827091Bach KP, Kuschel CA, Patterson N, Skwish H, Huth S, Phua HH, Bloomfield FH. Effect of Bias Gas Flow on Tracheal Cytokine Concentrations in Ventilated Extremely Preterm Infants: A Randomized Controlled Trial. Neonatology. 2021;118(3):332-339. doi: 10.1159/000515364. Epub 2021 Apr 7.
- Background: PubMed 19478530Bach KP, Kuschel CA, Oliver MH, Bloomfield FH. Ventilator gas flow rates affect inspiratory time and ventilator efficiency index in term lambs. Neonatology. 2009;96(4):259-64. doi: 10.1159/000220765. Epub 2009 May 27.
- Background: PubMed 23056572Bach KP, Kuschel CA, Hooper SB, Bertram J, McKnight S, Peachey SE, Zahra VA, Flecknoe SJ, Oliver MH, Wallace MJ, Bloomfield FH. High bias gas flows increase lung injury in the ventilated preterm lamb. PLoS One. 2012;7(10):e47044. doi: 10.1371/journal.pone.0047044. Epub 2012 Oct 8.
- Background: PubMed 32150670Chong D, Kayser S, Szakmar E, Morley CJ, Belteki G. Effect of pressure rise time on ventilator parameters and gas exchange during neonatal ventilation. Pediatr Pulmonol. 2020 May;55(5):1131-1138. doi: 10.1002/ppul.24724. Epub 2020 Mar 9.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of the FLOW-VENT 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 kristin.ferguson@mcri.edu.au, david.tingay@rch.org.au and mctc@mcri.edu.au.
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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.
Kristin N Ferguson, BSc MBBS principal investigator
Murdoch Childrens Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long PRT and Short PRT in people with Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, run by Murdoch Childrens Research Institute at 3 sites 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 4 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Kristin N Ferguson, BSc MBBS (+61383416200, kristin.ferguson@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (S/F Ratio) measured each minute during each treatment period (0 minutes to 4 hours) (time frame: 0 minutes then each minute up to 4 hours for each of the Long PRT and Short PRT 4-hour treatment periods). 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 NCT07101419, which also lists 5 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 24 Jun 2026.