Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)

Last updated: August 13, 2024
Sponsor: CHRISTUS Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anemia

Treatment

6 mg/kg of oral iron as ferrous sulfate administered every other day.

6 mg/kg of oral iron as ferrous sulfate administered every day.

Clinical Study ID

NCT06555315
2024-091
  • Ages 26-32
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children (Minor < 18 years of age)

  • Neonates

  • Hospitalized

  • Premature infants who are on full enteral feeds and are started on oral iron

  • Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth

Exclusion

Exclusion Criteria:

• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: 6 mg/kg of oral iron as ferrous sulfate administered every other day.
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
March 28, 2026

Study Description

Iron is an important component of hemoglobin, and an essential part of erythropoiesis. It is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. Iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. Premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate.

In older populations, EOD iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on EOD iron. Adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. Recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. Though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of EOD dosing of iron has not yet been examined in this population.

This is a non-inferiority, blinded, randomized control trial designed to investigate if EOD iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.

Connect with a study center

  • CHRISTUS Children's

    San Antonio, Texas 78207
    United States

    Active - Recruiting

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