Transition From Donor Milk: a Feasibility Study

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT06514014
Status
Recruiting
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Conditions

  • Nutrition, Healthy
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
28 Days - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preterm Infant Formula — DIETARY_SUPPLEMENT
    Transition from donor human milk to preterm infant formula

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Donor Milk
  • Active Comparator: Preterm Infant Formula

Primary Outcome Measure

Weight Velocity [ Time Frame: 36 weeks post menstrual age ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wellstar-MCGAugustaGeorgia30912
Brian Stansfield, MD
[email protected]
706-721-2331

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By research site
Wellstar-MCG· Augusta, GA

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