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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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?

Eligibility

Primary outcome measure(s)

• Length-for-age Z score (LAZ) — 3 Months
  Mean LAZ (SD, range) measured at birth, 2 weeks, 4 weeks and 3 months of age

Trial sites (4)