“A randomised, double blind, controlled trial to evaluate the effects of a new human milk fortifier on growth and tolerance in preterm infants”
The RENOIR study is registered at clinicaltrials.gov with the number NCT03315221. More details can be found here.
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.
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 neurodevelopment1.The preferred nutrition for preterm infants is human milk, preferably from the infant’s own mother. 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 2.
Methodology and intervention
The RENOIR study is a randomised, double blind controlled, parallel-group, multi-centre, multi-country trial to study the effects of a new HMF with added lipids on growth and tolerance in preterm infants (gestational age <32 weeks and birth weight <1500 g) fed human milk. The study consists of an intervention period where the infants receives the study product, and a follow-up period. Infants enrolled are expected to be able to complete an intervention period of at least 21 days. The intervention period ends when the infant no longer needs a HMF or is discharged home (whichever is first), and is for a maximal period of 16 weeks. The follow-up period, without study product consumption, lasts from the end of the intervention period until 24 months corrected age.
The RENOIR study aims to recruit 184 preterm infants in need of HMF. Subjects will be recruited in multiple sites in different countries and randomised to receive either:
- The study product: Multi-component HMF with added lipids
- The control product: Multi-component HMF (without lipids)
The primary parameter of the study is weight growth velocity (in g/kg/day) from baseline to study day 21, with the objective to demonstrate weight growth velocity in preterm infants receiving the new HMF with added lipids is non-inferior to those receiving the current HMF.
Secondary parameters measured include additional growth parameters (length and head circumference gain, weight/length/head circumference for age Z-scores) and gastrointestinal tolerance (Stool consistency / frequency, total enteral intake, vomiting and regurgitation, number of days that an infant is not fed enterally). In addition, neurocognitive development at 24 months corrected age will be measured by Bayley Scales of Infant and Toddler Development as an exploratory outcome.
In March 2018 the first preterm infant was enrolled in the RENOIR study.
Countries: France, Germany, The UK, the Netherlands
For more information please contact prof. dr. Ruurd van Elburg, Danone Nutricia Research (firstname.lastname@example.org).
For more information on Danone Nutricia Research’s work in preterm infants please see here