NCT05742815

Brief Summary

The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

February 15, 2023

Last Update Submit

February 15, 2023

Conditions

Breast Milk CollectionNutrition Disorder, Infant

Outcome Measures

Primary Outcomes (1)

  • Nutrient composition of donor human milk samples

    6 months

Interventions

No interventionOTHER

This is an observational collection of data from purchased donor milk samples

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Donor milk samples will be collected from commercially available donor milk banks

You may qualify if:

  • Donor human milk from commercially available milk banks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Publications (2)

  • Gates A, Maria SD, Meredith NA, Houslay T, Stansfield BK. Vitamin A in donor human milk: An experimental study. JPEN J Parenter Enteral Nutr. 2025 Nov;49(8):951-954. doi: 10.1002/jpen.70008. Epub 2025 Aug 20.

    PMID: 40836482DERIVED

  • Gates A, Hair AB, Salas AA, Thompson AB, Stansfield BK. Nutrient Composition of Donor Human Milk and Comparisons to Preterm Human Milk. J Nutr. 2023 Sep;153(9):2622-2630. doi: 10.1016/j.tjnut.2023.07.012. Epub 2023 Jul 28.

    PMID: 37517552DERIVED

MeSH Terms

Conditions

Breast Milk ExpressionInfant Nutrition Disorders

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Intructor

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

August 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)