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

Summary

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

• Very Preterm Infant
• Very Low Birthweight

Interventions

OTHER

Volume targets

* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding * Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]

DIETARY_SUPPLEMENT

Human Milk Fortifier

Human 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 \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]

Sponsors & Collaborators

• Boston Children's Hospital

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Emory University

  collaborator OTHER

• Muhimbili University of Health and Allied Sciences

  collaborator OTHER

• Jawaharlal Nehru Medical College

  collaborator OTHER

• PATH

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Katherine Semrau, PhD, MPH · Ariadne Labs | Harvard TH Chan School of Public Health and Brigham and Womens Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-16

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• India

Study Locations