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

University of Wisconsin, Madison2 sites in 1 country71 target enrollmentDecember 11, 2023

ConditionsRespiratory Distress of Newborn

InterventionsUltrasound

Overview

Phase: Not Applicable
Intervention: Ultrasound
Conditions: Respiratory Distress of Newborn
Sponsor: University of Wisconsin, Madison
Enrollment: 71
Locations: 2
Primary Endpoint: Ability of lung ultrasound score to predict extubation success
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 11, 2023

End Date

June 1, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Lung ultrasound

Participants undergo pre- and post-extubation lung ultrasound

Intervention: Ultrasound

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Change in respiratory rate(5 minutes before to 5 minutes after lung ultrasound)
Time to re-intubation(Up to 72 hours post-intubation)
Change in oxygen saturation(5 minutes before to 5 minutes after lung ultrasound)
Change in pre- and post-extubation lung ultrasound scores(12 hours pre-extubation to 24 hours post extubation)
Change in heart rate(5 minutes before to 5 minutes after lung ultrasound)