LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 48
SponsorHarvard School of Public Health (HSPH)
About this trial
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?
Eligibility criteria
Qualifiers
Very LBW (≤1.5kg)* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born**
Mother and infant alive during screening
Mother age 18+ years
Lives within catchment areas of the facility
Disqualifiers
Lives outside the defined catchment area
Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube [cleft lip/palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC]
Severe birth asphyxia
Critically ill (i.e. not on enteral feeds)
Trial design
Treatments tested in this trial
- Human Milk Fortifier
- Volume targets
Treatment groups
776 Participants
are divided into 2 treatment groupsSponsors and collaborators
Harvard School of Public Health (HSPH)
Lead sponsor
Boston Children's Hospital
Collaborator
Brigham and Women's Hospital
Collaborator
Emory University
Collaborator
Muhimbili University of Health and Allied Sciences
Collaborator
Jawaharlal Nehru Medical College
Collaborator
PATH
Collaborator
University of North Carolina
Collaborator
Source ClinicalTrials.gov