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Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period — T-NOX  

Cardiopulmonary Bypass Clinical Trial

Official title:
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period (T-NOX)

Clinical Trial 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, patients that participate 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04452188
Study type Interventional
Source University of Michigan
Contact
Status Active, not recruiting
Phase N/A
Start date January 18, 2021
Completion date August 2024
View Details
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