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

NCT ID: NCT03315221

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-08
• Study Completion Date: 2022-09-21

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test product

Human Milk Fortifier (HMF) with added lipids.

Group Type: EXPERIMENTAL

Test product

Intervention Type: OTHER

HMF with added lipids - Intervention group

Control product

Commercially available HMF (without lipids).

Group Type: ACTIVE_COMPARATOR

Control product

Intervention Type: OTHER

Commercially available HMF (without lipids) - control group

Interventions

Test product

HMF with added lipids - Intervention group

Intervention Type: OTHER

Control product

Commercially available HMF (without lipids) - control group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de la Croix Rousse

Lyon, , France

CHRU Nancy - Maternité regionale Universitaire A. Pinard

Nancy, , France

Universitätskinderklinik der Otto-v.-Guericke Universität

Magdeburg, , Germany

Klinikum Nürnberg Süd

Nuremberg, , Germany

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Ziekenhuisgroep Twente

Almelo, , Netherlands

Flevoziekenhuis

Almere Stad, , Netherlands

Amsterdam UMC (VUMC)

Amsterdam, , Netherlands

OLVG Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Spaarne Ziekenhuis

Hoofddorp, , Netherlands

Maastricht UMC

Maastricht, , Netherlands

VieCuri Medisch Centrum

Venlo, , Netherlands

Isala Ziekenhuis

Zwolle, , Netherlands

Saint-Peter's Hospital NHS Foundation Trust

Chertsey, , United Kingdom

Norfolk and Norwich NHS Foundation Trust

Norwich, , United Kingdom

Countries

France; Germany; Netherlands; United Kingdom

References

Picaud JC, Reynolds PR, Clarke P, van den Hooven E, van Weissenbruch MM, van Lingen RA, Goedhart A, Botma A, Boettger R, van Westering-Kroon E, Fusch C, Hascoet JM; RENOIR Study Group. A novel human milk fortifier supports adequate growth in very low birth weight infants: a non-inferiority randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2025 Aug 19;110(5):512-519. doi: 10.1136/archdischild-2024-327282.

Reference Type: DERIVED

PMID: 40037774 (View on PubMed)

Other Identifiers

EBB16GL06402

Identifier Type: -

Identifier Source: org_study_id