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

Recruiting now · Not applicable

Conditions studied: Very Preterm Infant, Very Low Birthweight

In brief

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?

Key facts

Study ID

NCT06765863

Run by

Harvard School of Public Health (HSPH)

People needed

776

Starts

2025-01-16

Expected to finish

2027-03-31

Last updated by the study team

2026-01-21

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Mother intends to stay in catchment area of the study facility for at least 3 months
• At randomization: Infant receiving at least 60 mL/kg/day of human milk***

You may not qualify if…

• 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)
• Unknown date of birth and unknown gestational age

Where it is running

• Ballari Medical College and Research Centre — Ballary, Karnataka, India (enrolling)
• JJM Medical College — Davangere, Karnataka, India (enrolling)
• Niloufer Hospital — Hyderabad, Telangana, India (enrolling)
• KLES Dr Prabhakar Kore Hospital & Medical Research Center — Belagavi, Karnataka, India

Full record on ClinicalTrials.gov

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