Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants: A Prospective, Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06843278

Enrollment

Registered

2025-02-24

Start date

2022-08-17

Completion date

2024-10-17

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ferritin Levels in Very Preterm Infants

Keywords

Breast milk, Donor breast milk, Ferritin level, 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).

Interventions

OTHERmaternal breast milk

Very preterm infants receiving maternal breast milk

OTHERDonor breast milk

Very preterm infants receiving donor breast milk

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 4 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The Average Serum ferritin level in very preterm infants	Until four weeks of age or discharge	The average serum ferritin level (ng/ml) in very preterm infants receiving donor breast milk or maternal breast milk

Secondary

Measure	Time frame	Description
The Average Hemoglobin levels (g/dl) in very preterm infants	Until four weeks of age or discharge	The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk
The Average Bilirubin Levels (mg/dL) in very preterm infants	until four weeks of age or discharge	The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026