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LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk

Study acronym: LIFT-UP RCT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 1162 to 776v4 Show 5 more changesShow less
    • Primary completion date: Jul 1, 2026 to Mar 31, 2027
    • Study completion date: Sep 1, 2026 to Mar 31, 2027
    • Eligibility criteria shortened, about 7 words
    • Study sites revised (4)
    • Study description shortened, about 3 words
  2. Study sites: 5 to 4
    • Eligibility criteria revised
    • Study description shortened, about 1 word
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2025 to Jan 16, 2025
    • Site details revised at 5 of 5 sites
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol. The primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?
Trial Details
NCT Number NCT06765863
Lead Sponsor Harvard School of Public Health (HSPH)
Collaborators: Boston Children's Hospital, Brigham and Women's Hospital, Emory University, Muhimbili University of Health and Allied Sciences, Jawaharlal Nehru Medical College, PATH, University of North Carolina
Conditions
(from sponsor)		 Very Preterm Infant, Very Low Birthweight
Enrollment 776 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov