Status:
COMPLETED
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
General Electric
Conditions:
Transposition of the Great Vessels
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief Summary
The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, s...
Eligibility Criteria
Inclusion
- Patients from birth to 6 months of age
- HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO
- Written parental informed consent
Exclusion
- Weight \< 2 kg
- Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.
- B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.
- Patients on ECMO preoperatively
- Clinically significant tracheo-esophageal fistula or known preoperative air leak
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02184169
Start Date
December 1 2012
End Date
January 29 2019
Last Update
June 4 2020
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115