Clinical trial NCT06843278: Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants
Official title: Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ferritin Levels in Very Preterm Infants
Keywords: Breast milk
Donor breast milk
Ferritin level
very preterm infants
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very preterm infants

Brief summary: This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).


Eligibility criteria: Inclusion Criteria:

1. All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children
2. Received either MBM or DBM starting between 5 to10 days of life

   a. Infants receiving \>50% feeding volume by DBM for the first 14 days of life will be considered to have received predominantly DBM. The comparison group will be infants who received \> 50% of MBM for the first 14 days of life.
3. Parent able to read and write in the English language.

Exclusion Criteria:

1. Death prior to completion of participation
2. Extremis with likelihood of death prior to completion of participation in the study
3. Blood transfusion as determined by clinical team during the study
4. Major congenital anomaly or genetic syndrome and
5. Major surgical GI conditions that preclude feeding

Primary outcomes:
measure: The Average Serum ferritin level in very preterm infants
timeFrame: Until four weeks of age or discharge
Secondary outcomes:
measure: The Average Hemoglobin levels (g/dl) in very preterm infants
timeFrame: Until four weeks of age or discharge
measure: The Average Bilirubin Levels (mg/dL) in very preterm infants
timeFrame: until four weeks of age or discharge
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdvenHealth
name: Anoop Pulickal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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