Lung Ultrasound - Prospective Study

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: Recruiting
• Conditions: Respiratory Distress of Newborn
• Intervention / Treatment: Device: Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meg Baker; Email: meg.baker@wisc.edu
• Study Contact Backup: Name: Adam S Bauer, MD; Phone Number: 608-417-6411; Email: adam.bauer@wisc.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Not yet recruiting
      • University of Minnesota
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • Unity-Point Health Meriter
      • Principal Investigator: Adam S Bauer, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	Length of time from extubation to re-intubation.	Up to 72 hours post-intubation
Change in heart rate	Measure of heart rate before and after ultrasound procedure	5 minutes before to 5 minutes after lung ultrasound
Change in respiratory rate	Measure of respiratory rate before and after ultrasound procedure	5 minutes before to 5 minutes after lung ultrasound
Change in oxygen saturation	Measure of oxygen saturation before and after ultrasound procedure	5 minutes before to 5 minutes after lung ultrasound

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: UnityPoint Health-Meriter
• Investigators: Principal Investigator: Adam S Bauer, MD, UnityPoint Health-Meriter

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

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 (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease
• Other Study ID Numbers: 2023-1132; 2023-026 (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