RecruitingNot ApplicableNCT07816601

Donor Breast Milk 2

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


Sponsor

AdventHealth

Enrollment

17 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 29 WeeksMax Age: 33 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ferrous Sulfate Oral Product for people with iron-deficiency anemia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerrous Sulfate Oral Product

Dietary Supplement


Locations(1)

AdventHealth Orlando

Orlando, Florida, United States

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NCT07816601


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