Iron Supplementation for Anemia of Prematurity
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation. The primary outcomes are intestinal health including microbiome, inflammation, and barrier function.
Will I have to stop taking my current medications?
The trial does not specify whether participants must stop taking their current medications. However, infants who require epogen (a medication to prevent blood transfusions) for religious reasons are excluded from the study.
Is iron supplementation safe for humans, including preterm infants?
Iron supplementation is generally safe for humans, including preterm infants, but it can cause stomach issues like vomiting, diarrhea, or constipation, especially with certain forms like ferrous sulfate. Nonionic iron forms may be better tolerated, and while iron is important, too much can lead to complications, so it's best used when there's a clear need.12345
How does the drug iron sulfate differ from other treatments for anemia of prematurity?
Iron sulfate is unique because it can be administered daily or weekly to prevent anemia in infants, offering flexibility in dosing schedules compared to other treatments. This approach may help ensure adequate iron levels in preterm infants who are at risk of anemia due to insufficient iron intake from diet alone.35678
What data supports the effectiveness of the drug Iron Sulfate for treating anemia of prematurity?
Research shows that iron supplementation, like Iron Sulfate, is important for improving iron nutritional status in preterm infants, which can help address anemia of prematurity. Studies on iron-fortified formulas and other iron supplements in preterm infants suggest that iron supplementation is beneficial in managing iron deficiency, a key factor in anemia.3891011
Are You a Good Fit for This Trial?
This trial is for very low birth weight infants under 1500g who haven't started oral iron supplements, are expected to live beyond two weeks, and have parental consent. Infants with congenital intestinal defects or a history of intestinal issues before starting supplements can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 6 mg/kg/day or 2 mg/kg/day of elemental iron until 36 weeks corrected gestational age or discharge
Sample Collection and Testing
Weekly stool and urine samples collected; blood tests at 4 weeks after birth; auditory brainstem response at 36 weeks corrected gestational age or discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Iron Sulfate
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator