Recruiting

Donor Human Milk

Sponsor:

Augusta University

Code:

NCT06514014

Conditions

Preterm Birth

Nutrition, Healthy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Preterm Infant Formula

Study Details

Brief summary:

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.

Conditions

Preterm Birth

Nutrition, Healthy

Study ID

NCT06514014

Start date

May 1, 2025

Status verified date

Apr, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Donor Milk

active comparator: Preterm Infant Formula

Interventions

Preterm Infant Formula

Transition from donor human milk to preterm infant formula

Primary outcome measure

  • Weight Velocity [ Time Frame: 36 weeks post menstrual age ]
  • Fat free mass [ Time Frame: 36 weeks post menstrual age ]

Central Contacts and Locations

Locations

Wellstar-MCG

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Brian Stansfield, MD

706-721-2331bstansfield@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Aug 24, 2025

Last verified

Apr, 2025

Keywords

  • newborn
  • human milk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2025-08-24.