Actively Recruiting
Neonatologist-performed Lung Ultrasound to Guide Respiratory Therapy and Prevent Extubation Failure in Term and Preterm Neonates - A Randomized Controlled Trial
Led by Medical University of Graz · Updated on 2024-06-21
40
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of lung ultrasound performed by neonatologists (NPLUS) to guide respiratory therapy and prevent extubation failure in newborns who have been on invasive mechanical ventilation. The study focuses on both preterm and full-term neonates and aims to assess how accurately NPLUS can detect lung issues after extubation and whether it helps prompt earlier interventions to avoid respiratory failure. The intervention involves conducting lung ultrasound scans using a high-frequency linear transducer probe while the neonate lies in a supine position. The scan covers six lung areas sequentially, and lung ultrasound scores are recorded at three specific time points after extubation. The ultrasound videos are reviewed by two independent neonatologists to ensure reliability. This approach helps assess lung aeration and identifies early signs of lung collapse or atelectasis, which may guide timely respiratory therapy adjustments. Participants will undergo lung ultrasounds at designated times after extubation to monitor lung condition. The main outcome measured is the rate of reintubation within 72 hours after extubation. Researchers will also observe whether early lung ultrasound findings lead to interventions that prevent clinical deterioration. The study involves careful monitoring of lung function and respiratory support needs during this critical period following weaning from mechanical ventilation.
CONDITIONS
Official Title
Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All preterm and full-term neonates receiving invasive mechanical ventilation at the Division of Neonatology of the Medical University of Graz
- Written informed consent was obtained from parents prior to extubation
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Pediatrics, Division of Neonatology, Medical University of Graz
Graz, Styria, Austria, 8036
Actively Recruiting
Research Team
B
Bernhard Schwaberger, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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