Lung Ultrasound - Prospective Study

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06140615
• Collaborator: UnityPoint Health-Meriter (Other)
• Enrollment: 180
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 19
• Patients Per Site: 90
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress of Newborn	Device: Ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ability of lung ultrasound score to predict extubation success [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).

Secondary Outcome Measures

1. Change in pre- and post-extubation lung ultrasound scores [12 hours pre-extubation to 24 hours post extubation]

   Ultrasound scores are measured on a 4-point scale (0=normal,3 = most abnormal).

2. Time to re-intubation [Up to 72 hours post-intubation]

   Length of time from extubation to re-intubation.

3. Change in heart rate [5 minutes before to 5 minutes after lung ultrasound]

   Measure of heart rate before and after ultrasound procedure

4. Change in respiratory rate [5 minutes before to 5 minutes after lung ultrasound]

   Measure of respiratory rate before and after ultrasound procedure

5. Change in oxygen saturation [5 minutes before to 5 minutes after lung ultrasound]

   Measure of oxygen saturation before and after ultrasound procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455
2	Unity-Point Health Meriter	Madison	Wisconsin	United States	53715

Sponsors and Collaborators

• University of Wisconsin, Madison
• UnityPoint Health-Meriter

Investigators

• Principal Investigator: Adam S Bauer, MD, UnityPoint Health-Meriter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT06140615
• Other Study ID Numbers: 2023-1132; 2023-026
• First Posted: Nov 20, 2023
• Last Update Posted: Nov 20, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Hyaline Membrane Disease; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Study Results

No Results Posted as of Nov 20, 2023