Donor Breast Milk 2
Key facts
- Who runs it
- AdventHealth
- Where
- Orlando, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 17 people, planned
- Started
- 6 May 2026
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- Ferrous Sulfate Oral Product
- Record updated
- 11 September 2026
Who can take part
- Age
- 29 weeks to 33 weeks
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study
- Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding
- Blood transfusion as determined by clinical team during the study
Where in United States
- AdventHealth OrlandoOrlando, United StatesContact: Anoop Pulickal, MD, PhDTaking people
About the trial
What the trial wants to find out
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?
Read full original descriptionShow less
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
The group in the trial
- Very preterm infantsTreatment being tested
Treatment: Ferrous Sulfate Oral Product
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Early Iron Supplementation in Very Preterm Infants Fed Donor Breast Milk: A Prospective, Interventional, Clinical Trial
- Record updated
- 11 September 2026