The RENOIR study is a randomised, double blind controlled, parallel-group, multi-centre, multi-country trial to study the effects of a new Human Milk Fortifier (HMF) with added lipids on growth and tolerance in preterm infants (gestational age <32 weeks and birth weight <1500 g) fed human milk.
Background
Preterm birth (birth before start of 37 weeks of gestation) is the number one cause of childhood mortality and morbidity, and as such is associated with long-term adverse consequences for health and neurodevelopment.
However, as preterm infants have significantly higher nutritional requirements than their term born peers it is recommended that human milk should be fortified to meet their nutritional needs. The RENOIR study aims to investigate the the effects of a new Human Milk Fortifier (HMF) with added lipids to support neurodevelopment on growth and tolerance in preterm infants.
Study Objectives
The primary objective of the RENOIR study is to demonstrate growth velocity of preterm infants receiving a new HMF with added lipids is non-inferior to those receiving a standard HMF. In addition, secondary and exploratory objectives include investigating the gastrointestinal tolerance of a new HMF with lipids, and its impact on neurocognitive development.
The RENOIR study aims to recruit 184 preterm infants in need of HMF. Subjects will be recruited in multiple sites in France, Germany, The UK and the Netherlands and randomised to receive either:
- The study product: Multi-component HMF with added lipids
- The control product: Multi-component HMF (without lipids)
In March 2018 the first infant was enrolled.
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