Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy
Australia20 participantsStarted 2025-03
Plain-language summary
The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need. The main question it aims to answer is:
When a baby's oxygen requirement goes up, does NPLUS help to target interventions and reduce oxygen requirements?
Researchers will compare NPLUS to standard treatment.
Participants will:
Have a lung ultrasound performed whenever their oxygen requirement increases by more than 10%.
The ultrasound findings will be used to target interventions that aim to improve air entry in the lungs.
Each time this happens, the researchers will note what happens to the oxygen requirement afterwards.
Each participant will participate for five days. For the first two days, they will be randomized to either the NPLUS arm or the usual care arm.
There is then a 24 hour period of usual care. For the final two days, participants cross over to the other arm of the trial.
Who can participate
Age range
1 Week
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All preterm infants (\<33 weeks gestational age) from their 2nd week of life, receiving respiratory support via NCPAP
* expected to stay on NCPAP for the following 5 days at the NICU, Royal Hospital for Women, Randwick, Sydney
* provided written informed consent obtained from parents.
Exclusion Criteria:
* Neonates with previous abdominal surgery
* Major congenital anomalies.
* \>33+0 weeks
* Less than 1 week of age
* Invasive ventilation
* Bilevel or Multilevel non-invasive ventilation
* Not expected respiratory support via CPAP for the following 5 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean ratio res/base (Resolution FiO2 / Baseline FiO2)
Timeframe: Resolution FiO2 assessed 1 hour after increased persisting (>10 min) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)