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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: Completed NA study, sponsored by University of Michigan.
NCT04452188 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Oxidative stress (OS) reflects an imbalance between the production and accumulation of reactive oxygen species. Oxidation of lipids leads to the generation of lipid peroxides which can be detected as Thiobarbituric acid reactive substances (TBARS). Thus, levels of serum TBARS were assessed in participants as indicators of OS. TBARS levels were assessed at three separate time points in the first 24 hours after surgery (2, 6, and 24 hours). Each participant's post-operative (PO) samples were norm
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 |
What the finished NCT04452188 record still lists
NCT04452188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Normoxia (with controlled re-oxygenation) is the first listed.
NCT04452188 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04452188's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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