Status:
COMPLETED
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
National Institutes of Health (NIH)
Conditions:
Hypoplastic Left Heart Syndrome
Total Anomalous Pulmonary Venous Return
Eligibility:
All Genders
Up to 29 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04452188
Start Date
January 18 2021
End Date
April 20 2023
Last Update
June 18 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109