Enteral Iron Supplementation and Intestinal Health in Preterm Infants
Who is this study for? Infant patients with Anemia
What treatments are being studied? Iron Sulfate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 6 months
Healthy Volunteers: t
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• \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (OIS), with mother at least 18 years of age, and parental consent.
Locations
United States
Florida
Tampa General Hospital
RECRUITING
Tampa
Contact Information
Primary
Marcia Kneusel
mkneusel@usf.edu
813-844-3395
Time Frame
Start Date: 2020-11-17
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 183
Treatments
Active_comparator: Low Iron Sulfate Supplementation
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.
Active_comparator: High Iron Sulfate Supplementation
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.
Related Therapeutic Areas
Sponsors
Leads: University of South Florida
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)