RECRUITING Not applicable ClinicalTrials.gov

Donor Breast Milk 2

Sponsor: AdventHealth • ClinicalTrials.gov ID: NCT07816601

Registry updated: 2026-09-11

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Description

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

Interventions

Ferrous Sulfate Oral Product (Drug)
Dietary Supplement

Eligibility criteria

Inclusion Criteria: * 1\. All preterm infants born between 29.0-32.6 weeks of gestational age and admitted to the NICU at Advent Health for Children 2. Infants likely to be receiving DBM between 5 to 14 days of life 3. Infants receiving \>50% of the feeding volume by DBM will be considered to have received DBM. Exclusion Criteria: 1. Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study 2. Blood transfusion as determined by clinical team during the study 3. Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding

Conditions

Iron Deficiency Anemia

Locations

AdventHealth Orlando — Orlando, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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