Status:
WITHDRAWN
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Anemia
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low. This may cause other health problems bec...
Detailed Description
At the beginning of the study, subjects will be randomized to two different groups. One group will receive iron every day for the next 4 months or so (up until their Glenn surgery); the other group wi...
Eligibility Criteria
Inclusion
- Single ventricle physiology (hypoplastic left heart syndrome \[HLHS\], tricuspid atresia, double inlet left ventricle \[DILV\], some double outlet right ventricle \[DORV\], heterotaxy, etc.)
- Age less than or equal to 2 months
- Saturations less than or equal to 90%
- Tolerating enteral feeds
- Informed consent being obtained
Exclusion
- Age \> 2 months
- Saturations \> 90%
- Total parenteral nutrition
- Chronic kidney disease
- Prior iron therapy
- Hemolytic anemia
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00459225
Start Date
April 1 2007
End Date
June 1 2013
Last Update
December 9 2014
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30312