Lung Ultrasound - Prospective Study

Not Applicable

Recruiting

• Conditions: Respiratory Distress of Newborn
• Interventions: Device: Ultrasound

• Registration Number: NCT06140615
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-20
• Study Start: 2023-12-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung ultrasound	Ultrasound	Participants undergo pre- and post-extubation lung ultrasound

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Unity-Point Health Meriter; 🇺🇸 Madison, Wisconsin, United States