Actively Recruiting

Phase Not Applicable
Age: 1Minute - 6Months
All Genders
ID06469580

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

Age: 1Minute - 6Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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