NCT07816601 · AdventHealth
Donor Breast Milk 2
What this study is about
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 .
View original scientific 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.
Interventions
DRUG
Ferrous Sulfate Oral Product
Dietary Supplement
Primary outcome measures
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
Time frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol
Time frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)
To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Orlando, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations