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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Human Milk Fortifier
Dietary supplementHuman milk fortifier added to expressed human milk (mother's own milk or pasteurized donor human milk) per feed per manufacturer's instructions for a minimum of 21 days (in-facility provision only) * Clinical feeding guideline including targets for initiation and advancement of breast milk feeding * Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Volume targets
Other intervention* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding * Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Treatment groups
776 Participants
are divided into 2 treatment groupsGroup A: Routine fortification of human milk with human milk fortifier using a standardized clinical protocolExperimental treatment 2 interventions
Group B: No routine fortification of human milk using a standardized clinical protocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length-for-age Z score (LAZ)
Mean LAZ (SD, range) measured at birth, 2 weeks, 4 weeks and 3 months of age
Time frame
3 MonthsSecondary outcomes
1
Length of Stay
Mean (SD) number of days admitted in the study facility from randomization to facility discharge
Time frame
From date of randomization until the date of facility discharge or date of death from any cause, whichever came first, assessed up to 3 months of age.2
Feeding intolerance
% infants identified with feeding intolerance
Time frame
From randomization to facility discharge, assessed up to 3 months of age3
Weight growth velocity
% infants attaining 15 g/kg/day
Time frame
From randomization to facility discharge, assessed up to 3 months of age4
Length gain
Mean (SD) change in length (mm/week)
Time frame
From randomization to facility discharge, assessed up to 3 months of age.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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