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NCT04151160 · ClinicalTrials.gov registry record
Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 72
- Enrollment target
NCT04151160: Completed study, sponsored by University of Colorado, Denver.
NCT04151160 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04151160 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 72 participants
- Enrollment target
Study Summary
Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.
Primary Outcome
Depth (in millimeters) of edema from skin ultrasound measurements.
Interventions
- DIAGNOSTIC_TEST Point of care ultrasound measurements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2021-07-01 |
What the finished NCT04151160 record still lists
NCT04151160 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 72 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Point of care ultrasound measurements is the first listed.
NCT04151160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04151160 about?
NCT04151160 is a clinical study titled "Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease". Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in...
What is the current status of trial NCT04151160?
This trial is currently completed. The enrollment target is 72 participants. The study started on 2020-01-13. Estimated completion is 2021-07-01.
What interventions are being tested in trial NCT04151160?
The interventions under investigation include: Point of care ultrasound measurements (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04151160?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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