Transition From Donor Milk: a Feasibility Study

NCT ID: NCT06514014

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-06-30

Brief Summary

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Preterm and very low birth weight (VLBW, \< 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. The investigators hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.

Detailed Description

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Conditions

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Preterm Birth Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Open Label Randomized Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Donor Milk

Group Type NO_INTERVENTION

No interventions assigned to this group

Preterm Infant Formula

Group Type ACTIVE_COMPARATOR

Preterm Infant Formula

Intervention Type DIETARY_SUPPLEMENT

Transition from donor human milk to preterm infant formula

Interventions

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Preterm Infant Formula

Transition from donor human milk to preterm infant formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Greater than 1,250 grams
2. At least 28 days of life
3. Diet consisting of donor human milk with/without mother's own milk

Exclusion Criteria

1. Birth weight below the 5th percentile
2. History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
3. Congenital anomalies
4. Care team discretion
Minimum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Brian Stansfield

Professor and Vice Chair for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wellstar-MCG

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Brian Stansfield, MD

Role: primary

706-721-2331

Other Identifiers

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2193903

Identifier Type: -

Identifier Source: org_study_id

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