Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

Completed

• Conditions: Ferritin Levels in Very Preterm Infants

• Registration Number: NCT06843278
• Lead Sponsor: AdventHealth

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-17
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Status Verified: 2025-01
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Orlando, Florida, United States