Lung Ultrasound - Prospective Study
The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation
4 other identifiers
interventional
71
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2023
CompletedFirst Posted
Study publicly available on registry
November 20, 2023
CompletedStudy Start
First participant enrolled
December 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
February 6, 2026
May 1, 2025
2.5 years
November 14, 2023
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change in pre- and post-extubation lung ultrasound scores
12 hours pre-extubation to 24 hours post extubation
Time to re-intubation
Up to 72 hours post-intubation
Change in heart rate
5 minutes before to 5 minutes after lung ultrasound
Change in respiratory rate
5 minutes before to 5 minutes after lung ultrasound
Change in oxygen saturation
5 minutes before to 5 minutes after lung ultrasound
Study Arms (1)
Lung ultrasound
EXPERIMENTALParticipants undergo pre- and post-extubation lung ultrasound
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation)
- Neonates with parents that are less than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Meriter Foundationcollaborator
Study Sites (2)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Unity-Point Health Meriter
Madison, Wisconsin, 53715, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam S Bauer, MD
Meriter Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2023
First Posted
November 20, 2023
Study Start
December 11, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 6, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share