NCT03315221

Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 1 Week – 32 Weeks
• Healthy volunteers: Not accepted

Summary

Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment. Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants. Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations. Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development. The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.

Conditions

• Subjects in Need of a Human Milk Fortifier (HMF)
• Growth
• Tolerance
• Safety

Interventions

Type	Name	Description
OTHER	Test product	HMF with added lipids - Intervention group
OTHER	Control product	Commercially available HMF (without lipids) - control group

Timeline

• Start date: 2018-03-08
• Primary completion: 2020-06-01
• Completion: 2022-09-21
• First posted: 2017-10-20
• Last updated: 2024-09-26

Locations

15 sites across 4 countries: France, Germany, Netherlands, United Kingdom