Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00459225
First received: April 10, 2007
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Anemia
Drug: Iron (ferrous sulfate)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease: An Open Label Trial

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Complete blood count, Iron study labs (ferritin, Total Iron Binding Capacity, and Iron lab) 72 hours prior to discharge following neonatal surgery [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]
  • Hemoglobin and Hematocrit at pre-Glenn catheterization [ Time Frame: Will be assessed at the pre-Genn catheterization ] [ Designated as safety issue: No ]
  • Complete Blood count, Iron study labs, and Reticulocyte count at pre-glenn screening [ Time Frame: Will be assessed at the pre-glenn screening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • feeding regimen and transfusion history at 72 hours prior to discharge from neonatal surgery, at pre-Glenn catheterization, and at pre-Glenn screening [ Time Frame: Will be assessed at the time of discharge, pre-Glenn catheterization and screening. ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
No Intervention: 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.

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 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)
  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Age > 2 months
  • Saturations > 90%
  • Total parenteral nutrition
  • Chronic kidney disease
  • Prior iron therapy
  • Hemolytic anemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459225

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30312
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: William Mahle, MD Emory University
  More Information

Publications:
Responsible Party: William T. Mahle, MD, Director of Clinical Research, Emory University
ClinicalTrials.gov Identifier: NCT00459225     History of Changes
Other Study ID Numbers: IRB00002287
Study First Received: April 10, 2007
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
Pediatrics
Cardiac Defect
Cardiac Surgery
Single Ventricle
Anemia
blood transfusions
red cell volume
red cell distribution
oral iron
ferrous sulfate
Congenital Cardiac Defects
Hemoglobin
Iron Deficiency

Additional relevant MeSH terms:
Anemia
Heart Diseases
Heart Defects, Congenital
Hematologic Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014