LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India
Harvard School of Public Health (HSPH)
776 participants
Jan 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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***
Exclusion Criteria5
- 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
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Interventions
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 \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding * Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06765863