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Lung Ultrasound for Breathing Difficulties in Newborns

N/A
Recruiting
Led By Adam S Bauer, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Neonates with parents that are less than 18 years old
Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours pre-extubation to 24 hours post extubation
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if lung ultrasound can help predict success of extubation in newborns with breathing difficulties.

Who is the study for?
This trial is for infants in the NICU with respiratory distress needing a breathing tube, who are ready to try breathing without it according to their doctor. They must be born at specific hospitals. Babies with major birth defects or those whose parents are minors cannot participate.
What is being tested?
The study is testing if lung ultrasounds can help predict whether babies with breathing difficulties can successfully breathe on their own after having their breathing tubes removed.
What are the potential side effects?
Lung ultrasound is generally safe and non-invasive, so there should be minimal side effects. The procedure may cause some discomfort due to the positioning of the baby during the scan.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My baby's parents are under 18.
Select...
I do not have any major congenital diseases like heart or lung malformations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours pre-extubation to 24 hours post extubation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours pre-extubation to 24 hours post extubation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability of lung ultrasound score to predict extubation success
Secondary study objectives
Change in heart rate
Change in oxygen saturation
Change in pre- and post-extubation lung ultrasound scores
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lung ultrasoundExperimental Treatment1 Intervention
Participants undergo pre- and post-extubation lung ultrasound
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~4090

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,799 Total Patients Enrolled
UnityPoint Health-MeriterUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Adam S Bauer, MDPrincipal InvestigatorUnityPoint Health-Meriter
~53 spots leftby Jun 2025
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