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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

207

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2018

Typical duration for phase_2

Geographic Reach

4 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

October 16, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed

5 months until next milestone

Study Start

First participant enrolled

March 8, 2018

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2.2 years

First QC Date

October 16, 2017

Last Update Submit

September 24, 2024

Conditions

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

Outcome Measures

Primary Outcomes (1)

Weight growth velocity
Weight growth velocity (in g/kg/day) from baseline to study day 21
21 days

Secondary Outcomes (10)

Length
up to 16 weeks, depending on gestational age at birth
Head circumference
up to 16 weeks, depending on gestational age at birth
Weight for Length
up to 16 weeks, depending on gestational age at birth
Z-scores
up to 16 weeks, depending on gestational age at birth
Stool consistency
up to 16 weeks, depending on gestational age at birth
+5 more secondary outcomes

Other Outcomes (23)

Exploratory - Age
2-16 weeks, depending on gestational age at birth
Exploratory - Age
4-16 weeks depending on gestational age at birth
Exploratory - Mortality
up to 16 weeks depending on gestational age at birth
+20 more other outcomes

Study Arms (2)

Test product

EXPERIMENTAL

Human Milk Fortifier (HMF) with added lipids.

Other: Test product

Control product

ACTIVE COMPARATOR

Commercially available HMF (without lipids).

Other: Control product

Interventions

Test productOTHER

HMF with added lipids - Intervention group

Test product

Control productOTHER

Commercially available HMF (without lipids) - control group

Control product

Eligibility Criteria

Age1 Week - 32 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Nutricia Researchlead

Study Sites (15)

Hôpital de la Croix Rousse

Lyon, France

Location

CHRU Nancy - Maternité regionale Universitaire A. Pinard

Nancy, France

Location

Universitätskinderklinik der Otto-v.-Guericke Universität

Magdeburg, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, Germany

Location

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Amsterdam UMC (VUMC)

Amsterdam, Netherlands

Location

OLVG Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

VieCuri Medisch Centrum

Venlo, Netherlands

Location

Isala Ziekenhuis

Zwolle, Netherlands

Location

Saint-Peter's Hospital NHS Foundation Trust

Chertsey, United Kingdom

Location

Norfolk and Norwich NHS Foundation Trust

Norwich, United Kingdom

Location

Related Publications (1)

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.
PMID: 40037774DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 20, 2017

Study Start

March 8, 2018

Primary Completion

June 1, 2020

Study Completion

September 21, 2022

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations

FR(2)GB(2)DE(2)NL(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Other Outcomes (23)

Study Arms (2)

Test product

Control product

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations