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Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease

NCT00459225 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-12-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • William Mahle, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459225 on ClinicalTrials.gov