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Iron Supplement

Oral Iron Supplements for Premature Infants

N/A
Recruiting
Led By Pratik K Parikh, MD
Research Sponsored by CHRISTUS Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children (Minor < 18 years of age)
Neonates
Must not have
Infants with conditions that affect iron metabolism (such as thalassemia or hemochromatosis)
Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 months
Awards & highlights

Summary

This trial aims to compare giving premature babies oral iron supplements every day versus every other day to see if both methods help the babies reach healthy iron levels by 36 weeks after birth.

Who is the study for?
This trial is for premature infants with conditions like very low birth weight and anemia due to iron deficiency. The study aims to include those who need iron supplementation as part of their care.
What is being tested?
The IQONic trial is testing whether giving premature infants oral iron supplements every day has the same effect on their health as giving the same total weekly dose divided over every other day.
What are the potential side effects?
Possible side effects from oral iron supplements can include stomach upset, constipation, diarrhea, or dark stools. However, these are common and not usually serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 years old.
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I am a newborn.
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I am currently in the hospital.
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My premature baby is on full oral feeds and has started on oral iron.
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My baby was born between 26 and 32 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My infant has a condition affecting iron levels, like thalassemia or hemochromatosis.
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My infant has a known genetic condition like Down syndrome.
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My infant has a bleeding disorder.
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My infant received iron injections before being assigned to a study group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA.
Secondary study objectives
Characterize Ret-Hb levels in preterm infants.
Characterize growth between two groups.
Determine prevalence of bronchopulmonary dysplasia between two groups.
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
After the infant achieves full enteral feeds, the infant is started on 6mg/kg of oral iron supplementation administered every other day. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status.
Group II: Control GroupExperimental Treatment1 Intervention
After the infant achieves full enteral feeds, the infant is started on 6 mg/kg of oral iron daily supplementation. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status.

Find a Location

Who is running the clinical trial?

CHRISTUS HealthLead Sponsor
13 Previous Clinical Trials
1,193 Total Patients Enrolled
Pratik K Parikh, MDPrincipal InvestigatorCHRISTUS Health
Richelle L Homo, MDPrincipal InvestigatorCHRISTUS Health; Brooke Army Medical Center
~67 spots leftby Mar 2026
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