As part of the LIFT-UP project, this randomized controlled trial (RCT) explores whether human milk fortification can improve growth and health outcomes for very low birthweight and/or very preterm infants. The trial is being conducted in India.
Why this matters
Small vulnerable newborns are especially prone to growth faltering, which carries lasting consequences for health and development. Human milk is the foundation of feeding for these infants, but the smallest and most immature infants need additional nutrients to grow well. This trial investigates aims to build the evidence-base around the conditional WHO recommendation of multicomponent fortification for very low birthweight and very preterm infants by investigating whether human milk fortification following a standardized clinical protocol with volume advancement targets and provision of the FSP+ improves post facility discharge growth and health outcomes
At sites in India, LIFT-UP also includes an RCT of human milk fortification for very low birthweight or very preterm infants in the NICU.
The trial, taking place in Karnataka and Telangana, assesses the efficacy and safety of standardized fortification for these infants. Fortifying breast milk with an additive to increase caloric intake can help give these particularly vulnerable infants the nutrition they need and set them up for survival and growth. All babies in the study receive care that includes the FSP+ and standardized protocols for feeding and increasing milk supply.
The intervention group additionally receives human milk fortifier according to a standard protocol. Babies are followed until three months of age to assess growth and other health outcomes. The World Health Organization conditionally recommends fortification for very preterm/very low birthweight infants, but more evidence is needed in low-resource settings. This is the largest randomized trial of human milk fortifier use in this population to date and will contribute to closing this evidence gap.
| Components of the RCT arms | Intervention | Comparison |
|---|---|---|
| Provision of guideline-driven standard of care (facility-based lactation support/feeding counseling + KMC + WASH package) | ✓ | ✓ |
| Encouragement to express with electric breast pumps | ✓ | ✓ |
| Adherence to standardized protocol on breast milk minimum volume targets and trajectories for very preterm/ very LBW babies based on birthweight | ✓ | ✓ |
| Fortification of human milk with powdered HMF | ✓ | Nil |
| Adherence to standardized stopping of +/- HMF criteria | ✓ | ✓ |