Clinical trial 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.
Official title: Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Subjects in Need of a Human Milk Fortifier (HMF)
Growth
Tolerance
Safety
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 207
Sex: ALL
Minimum age (years): 1
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Preterm infants fed own mother's milk (or donor human milk) in need of a HMF (as decided by the investigator)
2. Gestational age \<32 weeks and birth weight \<1500 g
3. Receiving enteral feeding
4. Expected to need a HMF for minimally 21 days
5. Written informed consent from custodial parent(s)

Exclusion Criteria:

1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation;
2. Presence or history of any gastrointestinal malformation, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher);
3. No realistic prospect of survival at the discretion of the attending physician;
4. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
5. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions.

Primary outcomes:
measure: Weight growth velocity
timeFrame: 21 days
Secondary outcomes:
measure: Length
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Head circumference
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Weight for Length
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Z-scores
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Stool consistency
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Stool frequency
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Enteral intake
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: vomiting
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Regurgitation
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Enteral feed
timeFrame: up to 16 weeks, depending on gestational age at birth.
Other outcomes:
measure: Exploratory - Age
timeFrame: 2-16 weeks, depending on gestational age at birth
measure: Exploratory - Age
timeFrame: 4-16 weeks depending on gestational age at birth
measure: Exploratory - Mortality
timeFrame: up to 16 weeks depending on gestational age at birth
measure: Exploratory - Enteral feeding volume
timeFrame: around 1-4 weeks, depending on gestational age at birth
measure: Exploratory - Gastric residuals
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Exploratory - Diarrhoea
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Exploratory - Constipation
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Exploratory - Weight
timeFrame: at 6, 12 and 24 months corrected age (CA)
measure: Exploratory - Length
timeFrame: at 6, 12 and 24 months corrected age (CA)
measure: Exploratory - Head circumference
timeFrame: at 6, 12 and 24 months corrected age (CA)
measure: Exploratory - Neurodevelopmental outcome
timeFrame: at 24 months CA
measure: Safety - Incidence (S)AE's
timeFrame: up to 24 months CA
measure: Safety - Frequency (S)AE's
timeFrame: up to 24 months CA
measure: Safety - Severity (S)AE's
timeFrame: up to 24 months CA
measure: Safety - Relatedness (S)AE's
timeFrame: up to 24 months CA
measure: Safety - Incidence Blood in stool
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Safety - Frequency Blood in stool
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Safety - Severity Blood in stool
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Safety - NEC
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Safety - Bronchopulmonary dysplasia
timeFrame: up to 16 weeks, depending on gestational age at birth)
measure: Safety - Serious neonatal infections
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Safety - Retinopathy of Prematurity
timeFrame: up to 16 weeks, depending on gestational age at birth
measure: Safety - Metabolic acidosis
timeFrame: up to 16 weeks, depending on gestational age at birth
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Nancy
country: France
facility: CHRU Nancy - Maternité regionale Universitaire A. Pinard
city: Magdeburg
country: Germany
facility: Universitätskinderklinik der Otto-v.-Guericke Universität
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC (VUMC)
city: Amsterdam
country: Netherlands
facility: OLVG Onze Lieve Vrouwe Gasthuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala Ziekenhuis
city: Chertsey
country: United Kingdom
facility: Saint-Peter's Hospital NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich NHS Foundation Trust
Study officials:
References: