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Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

NCT07101419 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-17

No results posted yet for this study

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?

Conditions

  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome in Premature Infant

Interventions

OTHER

Long PRT

PRT (in seconds) set at 75% of inspiratory time (in seconds)

OTHER

Short PRT

PRT (in seconds) set at 33% of inspiratory time (in seconds).

Sponsors & Collaborators

  • Mercy Hospital for Women, Australia

    collaborator OTHER

  • Royal Women's Hospital, Melbourne, Australia

    collaborator UNKNOWN

  • Western Health, Australia

    collaborator OTHER_GOV

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Kristin N Ferguson, BSc MBBS · Murdoch Childrens Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Hours
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07101419 on ClinicalTrials.gov