Status:
RECRUITING
Iron Supplementation and Intestinal Health
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Anemia of Prematurity
Very Low Birth Weight Infant
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
Brief 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 d...
Detailed Description
Infants and mothers will be recruited at a single academic level III NICU at Tampa General Hospital, Tampa, FL. Inclusion criteria infants: \<1500 g at birth, expected to live beyond 2 weeks, not yet ...
Eligibility Criteria
Inclusion
- \<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.
Exclusion
- congenital intestinal defects, history of intestinal infection or perforation before OIS. Infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study.
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04497012
Start Date
November 17 2020
End Date
July 31 2025
Last Update
January 22 2025
Active Locations (1)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606