Lung Ultrasound - Prospective Study

Respiratory Distress of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140615
• Other study ID #: 2023-1132
• Secondary ID: 2023-026
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: University of Wisconsin, Madison
• Contact: Adam S Bauer, MD
• Phone: 608-417-6411
• Email: adam.bauer[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Respiratory Distress of Newborn
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Ultrasound
Ultrasound of lungs

Locations

Country	Name	City	State
United States	Unity-Point Health Meriter	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	UnityPoint Health-Meriter

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to re-intubation	Length of time from extubation to re-intubation.	Up to 72 hours post-intubation
Secondary	Change in heart rate	Measure of heart rate before and after ultrasound procedure	5 minutes before to 5 minutes after lung ultrasound
Secondary	Change in respiratory rate	Measure of respiratory rate before and after ultrasound procedure	5 minutes before to 5 minutes after lung ultrasound
Secondary	Change in oxygen saturation	Measure of oxygen saturation before and after ultrasound procedure	5 minutes before to 5 minutes after lung ultrasound