RENOIR V1.1

• Research type

  Research Study

• Full title

  A randomised, double-blind, controlled trial to evaluate the effects of a new human milk fortifier on growth and tolerance in preterm infants

• IRAS ID

  232768

• Contact name

  Mrs. Maaike Hofman

• Contact email

  Maaike.hofman@nutricia.com

• Sponsor organisation

  NUTRICIA RESEARCH

• Clinicaltrials.gov Identifier

  NCT03315221

• Duration of Study in the UK

  3 years, 9 months, 30 days

• Research 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) in order 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 European Society for Paediatric Gastroenterology Hepatology
  and Nutrition (ESPGHAN) recommendations for intake of nutrients for preterm infants with a very low birth weight.
  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

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  17/LO/1947

• Date of REC Opinion

  12 Jan 2018

• REC opinion

  Further Information Favourable Opinion