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Preterm Infants Fed a Human Milk Fortifier

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 0 to 14v6
  2. Enrollment target: 178 to 321v5 Show 6 more changesShow less
    • Primary and study completion dates: Dec 2025 to Jan 2028
    • Start date: Jan 2024 to Sep 2024
    • Interventions: Control Product (Other), Experimental Product (Other) to Control Product (Other), Experimental Product 1 (Other), Experimental Product 2 (Other)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 7 of 9 entries
    • Study arms: 2 to 3
  3. Start date: May 2023 to Jan 2024v4
  4. Start date: Nov 2022 to May 2023
    • Primary and study completion dates: Jun 2025 to Dec 2025
    v3
  5. Study sites: 2 to 0v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
Trial Details
NCT Number NCT05551975
Lead Sponsor Abbott Nutrition
Conditions
(from sponsor)		 Growth
Enrollment 321 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov