Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease

NCT00459225 | Withdrawn

• 1 other identifier: IRB00002287
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anemia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Complete blood count, Iron study labs (ferritin, Total Iron Binding Capacity, and Iron lab) 72 hours prior to discharge following neonatal surgery

  Discharge from hospital

• Hemoglobin and Hematocrit at pre-Glenn catheterization

  Will be assessed at the pre-Genn catheterization

• Complete Blood count, Iron study labs, and Reticulocyte count at pre-glenn screening

  Will be assessed at the pre-glenn screening

Secondary Outcomes (1)

• feeding regimen and transfusion history at 72 hours prior to discharge from neonatal surgery, at pre-Glenn catheterization, and at pre-Glenn screening

  Will be assessed at the time of discharge, pre-Glenn catheterization and screening.

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

NO INTERVENTION

Group II will not receive iron but will be a participant in the study and follow the course of the non-iron randomized patients.

Interventions

Iron (ferrous sulfate) DRUG

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.

1

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Age \> 2 months
• Saturations \> 90%
• Total parenteral nutrition
• Chronic kidney disease
• Prior iron therapy
• Hemolytic anemia

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30312, United States

Location

Related Publications (5)

• 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.

  PMID: 15374802 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.

  PMID: 3044212 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.

  PMID: 8252568 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.

  PMID: 16442914 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.

  PMID: 6986756 BACKGROUND

MeSH Terms

Conditions

Anemia; Univentricular Heart; Heart Defects, Congenital; Iron Deficiencies

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• William Mahle, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)