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Transition From Donor Milk: a Feasibility Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date changed from estimate of Nov 1, 2024 to May 1, 2025
    • Study completion date: Jun 30, 2026 to Jun 30, 2027
    • Secondary endpoints revised (4)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06514014
Lead Sponsor Augusta University
Conditions
(from sponsor)		 Preterm Birth, Nutrition, Healthy
Related terms Premature Birth
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov