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

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?

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	Very Preterm Infant, Very Low Birthweight
Enrollment	776 participants
Start Date	2025-01-16
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-21