Neonates, Lung Disease
The primary purpose of this study is to evaluate the clinical effectiveness of LUS compared to current chest physiotherapy outcome measures in determining the need for and effect of physiotherapy on neonates. This will be done by comparing whether LUS is better at guiding CPT treatment than looking at the lungs with CXR and listening to the lungs using a stethoscope. Results may help us improve how CPT is delivered to babies in the future.
- Category
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Trial status
Recruiting
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Trial phase
Phase 0Sometimes referred to as Phase 0 trials or pilot studies, these come before Phase 1 trials and are used to test how the body responds to an experimental drug. In these studies, small doses of the new drug are given once or for a short time to a very limited number of people.
- Registry listing
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ERM Project ID
103799
Trial contact details
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Contact person
Dr Judith Hough
What you need to know
Who can take part?
Neonates who:
- Are admitted to the NICU.
- Require mechanically ventilated.
- Are identified as meeting criteria for physiotherapy assessment.
- Have had a CXR in the previous 24 hours
Additionally, the parent/guardian must:
- Have signed the consent form.
- Be competent in understanding what the process will involve, assuring informed consent is obtained.
What is involved for you?
The purpose of this study is to evaluate the clinical effectiveness and feasibility of LUS compared to current CPT outcome measures of auscultation and CXR, in guiding decision-making around the use of CPT in neonates.
Participants will undergo a routine respiratory physiotherapy assessment on admission by a trained neonatal physiotherapist using CXR and auscultation and a CPT intervention plan determined. Participants will then undergo an LUS assessment by a physiotherapist blinded to the original assessment findings and diagnosis. LUS diagnosis and findings will be shared with the physiotherapist who provided the initial assessment and a re-evaluation of intended treatment will occur.
Trial dates
June 2024-July 2024