Actively Recruiting
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
Led by Harvard School of Public Health (HSPH) · Updated on 2026-01-21
776
Participants Needed
4
Research Sites
114 weeks
Total Duration
On this page
Sponsors
H
Harvard School of Public Health (HSPH)
Lead Sponsor
B
Boston Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Very low birthweight (≤1.5 kg) or very preterm (≤32 weeks gestational age) infants admitted to NICU within 24 hours of birth for inborn infants and up to 48 hours for outborn infants
- Mother and infant alive during screening
- Mother aged 18 years or older
- Lives within the catchment area of the study facility
- Mother intends to remain within the catchment area for at least 3 months
- Infant receiving at least 60 mL/kg/day of human milk at randomization
You will not qualify if you...
- Lives outside the defined catchment area
- Congenital abnormalities or acquired conditions interfering with feeding or tube placement (such as cleft lip/palate, infections including toxoplasmosis, rubella, cytomegalovirus, herpes, Trisomy 21, cardiac defects, neural tube defects, gastrointestinal anomalies, hydrocephalus, necrotizing enterocolitis)
- Severe birth asphyxia
- Critically ill infants not receiving enteral feeds
- Unknown date of birth or unknown gestational age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Ballari Medical College and Research Centre
Ballary, Karnataka, India
Actively Recruiting
2
KLES Dr Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, India
Not Yet Recruiting
3
JJM Medical College
Davangere, Karnataka, India
Actively Recruiting
4
Niloufer Hospital
Hyderabad, Telangana, India
Actively Recruiting
Research Team
I
Ilana Dzuba, MHS
CONTACT
L
Linda Vesel, PhD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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