NCT06555315

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

Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: CHRISTUS Health · Academic / Other
• Sex: All
• Age: 26 Weeks – 32 Weeks
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Very Low Birth Weight Infant
• Premature Infants
• Anemia of Prematurity
• Iron Deficiency, Anaemia in Children
• Extremely Low Birth Weight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	6 mg/kg of oral iron as ferrous sulfate administered every other day.	6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.
DIETARY_SUPPLEMENT	6 mg/kg of oral iron as ferrous sulfate administered every day.	6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-03-28
• Completion: 2026-03-28
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: United States