Donor Breast Milk 2
ConditionIron Deficiency Anemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-33
SponsorAdventHealth
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Ferrous Sulfate Oral Product
DrugDietary Supplement
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: Very preterm infantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
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)2
To determine the hematocrit 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)Sponsors and contacts
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Source ClinicalTrials.gov