Clinical Trial

Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

Study acronym: FLOW-VENT
Not Yet Recruiting
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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?
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-28; most recent amendment 2026-06-21.
Trial Details
NCT Number NCT07101419
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: Mercy Hospital for Women, Australia, Royal Women's Hospital, Melbourne, Australia, Western Health, Australia
Conditions Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Enrollment 68 participants
Start Date 2027-02
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-24