Lung Ultrasound - Prospective Study

May 14, 2026 updated by: University of Wisconsin, Madison

The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation

The goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress.

Participants will undergo a lung ultrasound pre- and post-extubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Unity-Point Health Meriter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants born at UnityPoint Health Meriter Hospital and University of Minnesota admitted to the Neonatal Intensive Care Unit (NICU) with respiratory distress requiring intubation
  • Meeting the extubation readiness criteria per the attending neonatologist

Exclusion Criteria:

  • Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation)
  • Neonates with parents that are less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung ultrasound
Participants undergo pre- and post-extubation lung ultrasound
Device: Ultrasound
Ultrasound of lungs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of lung ultrasound score to predict extubation success
Time Frame: 12 hours pre-extubation to 24 hours post extubation
Correlate the lung ultrasound score to the success of extubation, which is defined as remaining extubated for >72 hours. Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).
12 hours pre-extubation to 24 hours post extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pre- and post-extubation lung ultrasound scores
Time Frame: 12 hours pre-extubation to 24 hours post extubation
Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).
12 hours pre-extubation to 24 hours post extubation
Time to re-intubation
Time Frame: Up to 72 hours post-intubation
Length of time from extubation to re-intubation.
Up to 72 hours post-intubation
Change in heart rate
Time Frame: 5 minutes before to 5 minutes after lung ultrasound
Measure of heart rate before and after ultrasound procedure
5 minutes before to 5 minutes after lung ultrasound
Change in respiratory rate
Time Frame: 5 minutes before to 5 minutes after lung ultrasound
Measure of respiratory rate before and after ultrasound procedure
5 minutes before to 5 minutes after lung ultrasound
Change in oxygen saturation
Time Frame: 5 minutes before to 5 minutes after lung ultrasound
Measure of oxygen saturation before and after ultrasound procedure
5 minutes before to 5 minutes after lung ultrasound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Meriter Foundation

Investigators

  • Principal Investigator: Adam S Bauer, MD, Meriter Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1751
  • 2023-1132 (Other Identifier: UW Madison)
  • 2023-026 (Other Identifier: Meriter)
  • non-PBA dated 7/8/24 (Other Identifier: Meriter)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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