Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease

Anemia Clinical Trial

Official title: Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease: An Open Label Trial

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 will not receive any iron. Those in the iron treatment arm of the study will receive iron education at discharge from their first stage surgery (Norwood or BTS surgery) and will be given vials of iron to take home. A patient will receive a set amount of iron (dose will be 3 mg/kg) once a day. Weekly follow-up phone calls will be conducted by study personnel to re-calculate dose of iron for parents (based on weight) as well as check on the status of the research subject.

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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Heart Defects, Congenital
• Heart Diseases

• NCT number: NCT00459225
• Study type: Interventional
• Source: Emory University
• Status: Withdrawn
• Phase: N/A
• Start date: April 2007
• Completion date: June 2013