Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07101419
Registration number
NCT07101419
Ethics application status
Date submitted
28/07/2025
Date registered
3/08/2025
Date last updated
4/09/2025
Titles & IDs
Public title
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Query!
Scientific title
Longer Pressure Rise Time During Mechanical Ventilation of Extremely Preterm Infants: A Randomised Crossover Trial
Query!
Secondary ID [1]
0
0
117784
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
FLOW-VENT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome, Newborn
0
0
Query!
Respiratory Distress Syndrome in Premature Infant
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Complications of newborn
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Long PRT
Other interventions - Short PRT
Experimental: Long-Short PRT Sequence - Long PRT set during first treatment period; Short PRT set during second treatment period
Experimental: Short-Long PRT Sequence - Short PRT set during first treatment period; Long PRT set during second treatment period
Other interventions: Long PRT
PRT (in seconds) set at 75% of inspiratory time (in seconds)
Other interventions: Short PRT
PRT (in seconds) set at 33% of inspiratory time (in seconds).
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
0 minutes then each minute up to 4 hours for each of the Long PRT and Short PRT 4-hour treatment periods
Query!
Secondary outcome [1]
0
0
Change in pressure rise time (PRT) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [2]
0
0
Change in mean airway pressure (MAP) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Measured during of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [3]
0
0
Change in positive end expiratory pressure (PEEP) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [4]
0
0
Change in peak inspiratory pressure (PIP) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [5]
0
0
Change in tidal volume (VT) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [6]
0
0
Change in respiratory rate measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [7]
0
0
Change in minute ventilation measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [8]
0
0
Change in endotracheal tube leak measured each minute during each treatment period (0 minutes to 4 hours)
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [9]
0
0
Change in inspiratory time (Ti) measured each minute during each treatment period (0 minutes to 4 hours)
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [10]
0
0
Change in inspiratory gas flows measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [11]
0
0
Change in peripheral oxygen saturation (SpO2) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [12]
0
0
Change in fraction of inspired oxygen (FiO2) measured each minute during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [13]
0
0
Change in incidence of significant oxygen desaturation measured during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [13]
0
0
Significant oxygen desaturation is defined as SpO2 \<80% for \>30 seconds
Query!
Timepoint [13]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [14]
0
0
Change in total number FiO2 changes measured during each treatment period (0 minutes to 4 hours).
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.
Query!
Secondary outcome [15]
0
0
Incidence of air leak (pneumothorax or pneumomediastinum)
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Completed for each participant at end of their study period: 22-24 hours from study commencement.
Query!
Secondary outcome [16]
0
0
Incidence of pulmonary haemorrhage receiving management (increased PEEP/PIP/FiO2 or blood products)
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Completed for each participant at end of their study period: 22-24 hours from study commencement.
Query!
Secondary outcome [17]
0
0
Incidence of resuscitation (defined as receiving external cardiac compressions or adrenaline boluses)
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Completed for each participant at end of their study period: 22-24 hours from study commencement.
Query!
Secondary outcome [18]
0
0
Incidence of death
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Completed for each participant at end of their study period: 22-24 hours from study commencement.
Query!
Secondary outcome [19]
0
0
Incidence of treating consultant request to discontinue randomly allocated PRT prematurely
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
Completed for each participant at end of their study period: 22-24 hours from study commencement.
Query!
Eligibility
Key inclusion criteria
* 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.
Query!
Minimum age
6
Hours
Query!
Query!
Maximum age
7
Days
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/10/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/08/2027
Query!
Actual
Query!
Sample size
Target
68
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Mercy Hospital for Women - Heidelberg
Query!
Recruitment hospital [2]
0
0
The Royal Women's Hospital - Parkville
Query!
Recruitment hospital [3]
0
0
Joan Kirner Women's and Children's Hospital - Saint Albans
Query!
Recruitment postcode(s) [1]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [2]
0
0
3051 - Parkville
Query!
Recruitment postcode(s) [3]
0
0
3021 - Saint Albans
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Murdoch Childrens Research Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Mercy Hospital for Women, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Royal Women's Hospital, Melbourne, Australia
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Government body
Query!
Name [3]
0
0
Western Health, Australia
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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. 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?
Query!
Trial website
https://clinicaltrials.gov/study/NCT07101419
Query!
Trial related presentations / 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. Sherer JL. Survey highlights the occupational hazards of nursing. Hospitals. 1993 May 20;67(10):60. No abstract available. Bach 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. Riley M. Testimony of the American Society for Microbiology before the House Subcommittee on Investigations and Oversight, House Subcommittee on Natural Resources, Agriculture Research and Environment, and the House Subcommittee on Science, Research and Technology of the House Committee on Science and Technology. Hearing on "The coordinated framework for the regulation of biotechnology", July 23, 1986. Recomb DNA Tech Bull. 1986 Sep;9(3):151-61. No abstract available. Chong 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Kristin N Ferguson, BSc MBBS
Query!
Address
0
0
Murdoch Childrens Research Institute
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Kristin N Ferguson, BSc MBBS
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61383416200
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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
[email protected]
,
[email protected]
and
[email protected]
.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
Query!
When will data be available (start and end dates)?
6 months after publication of primary outcome.
Query!
Available to whom?
Prior to releasing any data the following are required:
1. A Data Transfer Agreement must be signed between relevant parties.
2. 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.
3. 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.
4. Agreement to cover any additional costs relating to the provision of the data.
5. 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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.mcri.edu.au/research/core-facilities-services/melbourne-children-trials-centre
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07101419
Download to PDF