Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

February 20, 2025 updated by: AdventHealth

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Very preterm infants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Very preterm infants receiving breast milk
Other: maternal breast milk
Very preterm infants receiving maternal breast milk
Very preterm infants receiving donor breast milk
Other: Donor breast milk
Very preterm infants receiving donor breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Average Serum ferritin level in very preterm infants
Time Frame: 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
Until four weeks of age or discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Average Hemoglobin levels (g/dl) in very preterm infants
Time Frame: 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
Until four weeks of age or discharge
The Average Bilirubin Levels (mg/dL) in very preterm infants
Time Frame: 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
until four weeks of age or discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Anoop Pulickal, MD, AdvenHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Actual)

October 17, 2024

Study Completion (Actual)

October 17, 2024

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1878559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe