| NCT ID | NCT07816601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AdventHealth |
| Condition | Iron Deficiency Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2026-05-06 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07816601 clinical trial?
This trial is open to participants of all sexes, aged 29 Weeks or older, up to 33 Weeks, studying Iron Deficiency Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07816601 currently recruiting?
Yes, NCT07816601 is actively recruiting participants. Contact the research team at Anoop.Pulickal.MD@adventhealth.com for enrollment information.
Where is the NCT07816601 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT07816601 clinical trial?
NCT07816601 is sponsored by AdventHealth. The trial plans to enroll 17 participants.