What this study is
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
What's being tested
- Ferrous Sulfate Oral Product
Intervention · DRUG
Dietary Supplement
Study details
- Official title
- Early Iron Supplementation in Very Preterm Infants Fed Donor Breast Milk: A Prospective, Interventional, Clinical Trial
- Sponsor
- AdventHealth
- Conditions
- Iron Deficiency Anemia
- Enrolling
- 17 people
- Starts
- 2026-05-06
- Est. completion
- 2027-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 29 Weeks – 33 WeeksSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study
- Blood transfusion as determined by clinical team during the study
- Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openAdventHealth Orlando
Orlando, Florida, United States
Recruiting
Study team
Sponsor
AdventHealth
Study ID 2372858
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.