Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

Starting soon · Not applicable

Conditions studied: Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant

In brief

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?

Key facts

Study ID: NCT07101419
Run by: Murdoch Childrens Research Institute
People needed: 68
Starts: 2027-02-01
Expected to finish: 2028-02-01
Last updated by the study team: 2026-06-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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