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RECRUITING
NCT07816601
NA

Donor Breast Milk 2

Sponsor: AdventHealth

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol . The main questions it aims to answer are: Does earlier iron supplementation provide increased ferritin levels at 14 and 28 days of life in subjects fed primarily donor breast milk? Iron supplementation will be implemented when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life. At day of life(DOL) 14 (± 4 days), a blood sample will be obtained for serum ferritin determination. Similarly, a second blood draw would be performed at day of life 28 (± 4 days) or prior to discharge, whichever comes earlier

Official title: Early Iron Supplementation in Very Preterm Infants Fed Donor Breast Milk: A Prospective, Interventional, Clinical Trial

Key Details

Gender

All

Age Range

29 Weeks - 33 Weeks

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2026-05-06

Completion Date

2027-12

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

Ferrous Sulfate Oral Product

Dietary Supplement

Locations (1)

AdventHealth Orlando

Orlando, Florida, United States