Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
NCT ID: NCT07101419
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
68 participants
INTERVENTIONAL
2026-02-28
2027-08-31
Brief Summary
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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
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Long-Short PRT Sequence
Long PRT set during first treatment period; Short PRT set during second treatment period
Long PRT
PRT (in seconds) set at 75% of inspiratory time (in seconds)
Short PRT
PRT (in seconds) set at 33% of inspiratory time (in seconds).
Short-Long PRT Sequence
Short PRT set during first treatment period; Long PRT set during second treatment period
Long PRT
PRT (in seconds) set at 75% of inspiratory time (in seconds)
Short PRT
PRT (in seconds) set at 33% of inspiratory time (in seconds).
Interventions
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Long PRT
PRT (in seconds) set at 75% of inspiratory time (in seconds)
Short PRT
PRT (in seconds) set at 33% of inspiratory time (in seconds).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
6 Hours
7 Days
ALL
No
Sponsors
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Mercy Hospital for Women, Australia
OTHER
Royal Women's Hospital, Melbourne, Australia
UNKNOWN
Western Health, Australia
OTHER_GOV
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kristin N Ferguson, BSc MBBS
Role: PRINCIPAL_INVESTIGATOR
Murdoch Childrens Research Institute
Locations
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Mercy Hospital for Women
Heidelberg, Victoria, Australia
The Royal Women's Hospital
Parkville, Victoria, Australia
Joan Kirner Women's and Children's Hospital
Saint Albans, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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117784
Identifier Type: -
Identifier Source: org_study_id