183 Participants Needed

Iron Supplementation for Anemia of Prematurity

MK
Overseen ByMarcia Kneusel
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

parental consent
I weighed less than 1500 grams at birth.
I have not started taking oral iron supplements.
See 1 more

Exclusion Criteria

My infant does not need epogen for religious reasons to avoid blood transfusions.
I have had an intestinal infection or perforation before.
You were born with a defect in your intestines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either 6 mg/kg/day or 2 mg/kg/day of elemental iron until 36 weeks corrected gestational age or discharge

Up to 22 weeks
Weekly monitoring and dose adjustment

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

Throughout treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Iron Sulfate
Trial Overview The study tests the effects of two different doses of iron sulfate (2 mg/kg/day vs. 6 mg/kg/day) on the intestinal health of very low birth weight infants, focusing on their microbiome, inflammation levels, and barrier function.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: High Iron Sulfate SupplementationActive Control1 Intervention
Participants will be given 6 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study iron dose until 36 week corrected gestational age or discharge, whichever comes first.
Group II: Low Iron Sulfate SupplementationActive Control1 Intervention
Participants will be given 2 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study iron dose until 36 week corrected gestational age or discharge, whichever comes first.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

In a study of 402 very low birth weight preterm infants, those receiving restrictive red blood cell transfusions showed significantly improved iron status, including higher hemoglobin and ferritin levels, after iron supplementation compared to non-transfused infants.
Iron supplementation (5 mg/kg/day) was deemed safe, as it did not increase the incidence of morbidities associated with prematurity, indicating that this practice can effectively support the iron needs of VLBW preterm infants.
Iron supplementation for preterm infants receiving restrictive red blood cell transfusions: reassessment of practice safety.Arnon, S., Dolfin, T., Bauer, S., et al.[2013]
Early supplementation of 5 mg/kg/d enteral iron polymaltose complex (IPC) starting at 2 weeks of age in preterm infants significantly improved iron status compared to starting at 4 weeks, as shown by better hemoglobin levels at 4 and 8 weeks of age.
The early iron supplementation also led to a reduced need for red blood cell transfusions (RBCTs), with only 1 infant in the 2-week group requiring a transfusion compared to 10 in the 4-week group, indicating a beneficial effect without increasing morbidity associated with prematurity.
The efficacy and safety of early supplementation of iron polymaltose complex in preterm infants.Arnon, S., Shiff, Y., Litmanovitz, I., et al.[2019]
A meta-analysis of 15 studies involving 1938 pregnant women with iron deficiency anemia found that intravenous iron therapy may reduce the need for blood transfusions at delivery compared to oral iron, but the evidence quality was low.
While intravenous iron showed some benefits in improving maternal blood parameters and slightly increasing neonatal birth weight, the overall differences in outcomes between intravenous and oral iron were small and not strongly supported by high-quality evidence.
Intravenous or oral iron for treating iron deficiency anaemia during pregnancy: systematic review and meta-analysis.Qassim, A., Grivell, RM., Henry, A., et al.[2020]

Citations

Iron supplementation for preterm infants receiving restrictive red blood cell transfusions: reassessment of practice safety. [2013]
The efficacy and safety of early supplementation of iron polymaltose complex in preterm infants. [2019]
Intravenous or oral iron for treating iron deficiency anaemia during pregnancy: systematic review and meta-analysis. [2020]
Gestational age-specific reference ranges of hepcidin in cord blood. [2015]
Iron nutritional status in preterm infants fed formulas fortified with iron. [2019]
Iron supplementation in preterm infants: a study comparing the effect and tolerance of a Fe2+ and a nonionic FeIII compound. [2006]
[Clinical study of iron protein succinylate oral solution for preventing and treating anemia of prematurity]. [2017]
Screening, Treatment, and Monitoring of Iron Deficiency Anemia in Pregnancy and Postpartum. [2022]
Iron status during pregnancy: setting the stage for mother and infant. [2023]
Iron deficiency and anemia in iron-fortified formula and human milk-fed preterm infants until 6 months post-term. [2021]
Effectiveness of daily and weekly iron supplementation in the prevention of anemia in infants. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity