Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
NCT06555315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-08-15
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
Conditions
- Very Low Birth Weight Infant
- Premature Infants
- Anemia of Prematurity
- Iron Deficiency, Anaemia in Children
- Extremely Low Birth Weight
Interventions
- 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.
Sponsors & Collaborators
-
CHRISTUS Health
lead OTHER
Principal Investigators
-
Pratik K Parikh, MD · CHRISTUS Health
-
Richelle L Homo, MD · CHRISTUS Health; Brooke Army Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 26 Weeks
- Max Age
- 32 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2026-03-28
- Completion
- 2026-03-28
Countries
- United States
Study Locations
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