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NCT04452188 · ClinicalTrials.gov registry record · NA
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT04452188 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 29 participants.
The verdict
NCT04452188, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study Summary
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: * that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group * there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. * the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery
Interventions
- OTHER Normoxia (with controlled re-oxygenation)
- OTHER Standard of care ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2023-04-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04452188
The ClinicalTrials.gov registry entry for NCT04452188 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normoxia (with controlled re-oxygenation) is the first listed.
NCT04452188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04452188 about?
NCT04452188 is a clinical study titled "Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period". This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the...
What is the current status of trial NCT04452188?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2021-01-18. Estimated completion is 2023-04-20.
What interventions are being tested in trial NCT04452188?
The interventions under investigation include: Normoxia (with controlled re-oxygenation) (OTHER), Standard of care ventilation (OTHER).
Who is sponsoring clinical trial NCT04452188?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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