Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
NCT ID: NCT00459225
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-04-30
2013-06-30
Brief Summary
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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.
Detailed Description
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Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients.
Blood samples will also be drawn at the same time as standard of care labs at two time points during the course of the study for both groups of patients. Blood for iron study labs will be drawn at 72 hours prior to discharge from the first stage surgery and at the pre-Glenn screening. A reticulocyte count test will also be done at the pre-Glenn screening. These lab tests look at the number of red blood cells in the body, the type of red blood cells, their ability to carry oxygen and the iron status of the research subject. Additionally, data will be collected on the CBC count, subject's age, weight, pulse oximetry, surgical history, transfusion history, iron levels and therapy, and hematological indices (Hgb, Hct, MCV, RDW, RBC count, and reticulocyte count), as well as peripheral blood smear. Feeding history will be carefully documented. Descriptive demographic data and underlying diagnosis will be collected, along with all the above variables defined.
The hemoglobin and iron levels at the time of pre-Glenn labs will be compared to those at the start of the study. The importance of iron therapy will be examined.
Iron is a readily available medicine for both the prevention and treatment of anemia. If this simple cost-effective medicine can decrease the prevalence of anemia in these infants, it may result in more oxygen to the body's tissues and areas, less stress on the single pumping chamber of the heart and it may also improve their overall growth and development.
1. Primary Aim - To achieve a higher hemoglobin level at time of second stage surgery (Glenn procedure).
2. Secondary Aims - To obtain the following outcomes:
1. Increased ferritin levels
2. Decreased interval blood transfusions
3. Normal MCV (red cell volume) and RDW (red cell distribution)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
The parent/guardian will be educated on the iron study and provided the opportunity to ask questions. If the parent/guardian chooses to participate in the study, the parent/guardian will give informed consent for the patient to be placed in either Group I or Group II, based upon guardian/parents' choice for participation in the iron arm of the study. Group I will be randomized in a 1:1 ratio in this open label trial to either receive or not receive iron. Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients.
Iron (ferrous sulfate)
The subjects in the iron treatment arm of the study will receive 3 mg/kg of oral/enteral iron solution once a day beginning at the time of discharge until the pre-Glenn screening which is the endpoint of the study. The iron will be dispensed for the subjects upon discharge from the hospital. The subjects randomized to the no iron treatment arm and the patients in Group II of the study will not receive iron upon discharge. However, they may be started on iron therapy in an intent-to-treat anemia by their primary physician in which case this will serve as the endpoint of the study for these participants.
2
Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients.
No interventions assigned to this group
Interventions
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Iron (ferrous sulfate)
The subjects in the iron treatment arm of the study will receive 3 mg/kg of oral/enteral iron solution once a day beginning at the time of discharge until the pre-Glenn screening which is the endpoint of the study. The iron will be dispensed for the subjects upon discharge from the hospital. The subjects randomized to the no iron treatment arm and the patients in Group II of the study will not receive iron upon discharge. However, they may be started on iron therapy in an intent-to-treat anemia by their primary physician in which case this will serve as the endpoint of the study for these participants.
Eligibility Criteria
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Inclusion Criteria
* Age less than or equal to 2 months
* Saturations less than or equal to 90%
* Tolerating enteral feeds
* Informed consent being obtained
Exclusion Criteria
* Saturations \> 90%
* Total parenteral nutrition
* Chronic kidney disease
* Prior iron therapy
* Hemolytic anemia
2 Months
ALL
No
Sponsors
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Children's Healthcare of Atlanta
OTHER
Emory University
OTHER
Responsible Party
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William T. Mahle, MD
Director of Clinical Research
Principal Investigators
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William Mahle, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IRB00002287
Identifier Type: -
Identifier Source: org_study_id