drugset / Trial / NCT00459225
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
RandomizedParallel-groupOpen-labelPrevention
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 because red blood cells contain hemoglobin, which carries oxygen (needed for survival) to different parts of the body. This study will look at the role of iron in preventing anemia in infants with one pumping chamber. The importance of iron therapy will be examined. Hypothesis: Prophylactic use of iron in infants with single ventricle is effective in preventing anemia.
Timeline
- Start
- 2007-04
- Primary completion
- 2013-06
- Completion
- 2013-06
Publications
- Background Kaemmerer H, Fratz S, Braun SL, Koelling K, Eicken A, Brodherr-Heberlein S, Pietrzik K, Hess J. Erythrocyte indexes, iron metabolism, and hyperhomocysteinemia in adults with cyanotic congenital cardiac disease. Am J Cardiol. 2004 Sep 15;94(6):825-8. doi: 10.1016/j.amjcard.2004.06.014.
- Background Perloff JK, Rosove MH, Child JS, Wright GB. Adults with cyanotic congenital heart disease: hematologic management. Ann Intern Med. 1988 Sep 1;109(5):406-13. doi: 10.7326/0003-4819-109-5-406.
- Background Perloff JK. Systemic complications of cyanosis in adults with congenital heart disease. Hematologic derangements, renal function, and urate metabolism. Cardiol Clin. 1993 Nov;11(4):689-99.
- Background Felker GM, Shaw LK, Stough WG, O'Connor CM. Anemia in patients with heart failure and preserved systolic function. Am Heart J. 2006 Feb;151(2):457-62. doi: 10.1016/j.ahj.2005.03.056.
- Background Dallman PR, Siimes MA, Stekel A. Iron deficiency in infancy and childhood. Am J Clin Nutr. 1980 Jan;33(1):86-118. doi: 10.1093/ajcn/33.1.86. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 3 mg/kg | Oral |