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

  • STATUS
    Recruiting
  • End date
    Aug 21, 2022
  • participants needed
    42
  • sponsor
    University of Michigan
Updated on 21 October 2021

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

Details
Condition Tetralogy of Fallot, Transposition of Great Vessels, transposition of the great arteries, Congenital Heart Disease, Double Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary Stenosis, Hypoplastic Left Heart Syndrome, Congenital Heart Defect, transposition of the great vessels, Persistent truncus arteriosus, Truncus Arteriosus, Scimitar Syndrome, Pulmonary Atresia With Ventricular Septal Defect, Heart Defect, transposition of great arteries, Cardiopulmonary Bypass, Double Outlet Right Ventricle, heart/lung bypass
Treatment Normoxia (with controlled re-oxygenation), Standard of care ventilation
Clinical Study IdentifierNCT04452188
SponsorUniversity of Michigan
Last Modified on21 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest)
Diagnosis with cyanosis at baseline (pre-operative PaO2 of less than 50mmHG) due to
Complete admixture lesion (example: hypoplastic left heart syndrome, total anomalous pulmonary venous return, truncus arteriosus, pulmonary atresia with VSD)
Transposition physiology (example: D-Transposition of the great arteries or Double outlet right ventricle with subpulmonary VSD)
Right-to-left shunt (example: Tetralogy of Fallot, double outlet right ventricle with subaortic VSD and pulmonary stenosis)

Exclusion Criteria

Corrected gestation at time of surgery less than 37 weeks
Prior cardiac arrest
Current or prior history of extracorporeal membrane oxygenation (ECMO) support
Current or prior history of needing renal replacement therapy with dialysis
Prior cardiac surgery requiring cardiopulmonary bypass
Diagnosis of Ebstein's Anomaly
Known genetic syndrome other than Trisomy 21 or DiGeorge Syndrome
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