Subjects in Need of a Human Milk Fortifier (HMF)Phase 2/3RenoirNCT03315221
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
A Phase 2/3 study testing Test product in people with Subjects in Need of a Human Milk Fortifier (HMF) and Growth, run by Nutricia Research at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 32 weeks
- Conditions the study is for
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance
- What is being tested?
- Test product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 8 Mar 2018to 21 Sep 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Netherlands9 sites
Noordwest Ziekenhuisgroep
Alkmaar
Ziekenhuisgroep Twente
Almelo
Flevoziekenhuis
Almere Stad
Amsterdam UMC (VUMC)
Amsterdam
OLVG Onze Lieve Vrouwe Gasthuis
Amsterdam
Spaarne Ziekenhuis
Hoofddorp
Maastricht UMC
Maastricht
VieCuri Medisch Centrum
Venlo
Isala Ziekenhuis
Zwolle
France2 sites
Hôpital de la Croix Rousse
Lyon
CHRU Nancy - Maternité regionale Universitaire A. Pinard
Nancy
Germany2 sites
Universitätskinderklinik der Otto-v.-Guericke Universität
Magdeburg
Klinikum Nürnberg Süd
Nuremberg
United Kingdom2 sites
Saint-Peter's Hospital NHS Foundation Trust
Chertsey
Norfolk and Norwich NHS Foundation Trust
Norwich
About this study
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.
Read more
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.
- Being tested
- Test product, Control product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test productOther
HMF with added lipids - Intervention group
Control productOther
Commercially available HMF (without lipids) - control group
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Human Milk Fortifier (HMF) with added lipids. Receives: Other: Test product |
| Control product | Active comparator | Commercially available HMF (without lipids). Receives: Other: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight growth velocity
Weight growth velocity (in g/kg/day) from baseline to study day 21
Measured: 21 days
Secondary outcomes (10)
Length
Length gain (cm/week)
Measured: up to 16 weeks, depending on gestational age at birth
Head circumference
Head circumference gain (cm/week)
Measured: up to 16 weeks, depending on gestational age at birth
Weight for Length
Weight for Length
Measured: up to 16 weeks, depending on gestational age at birth
Z-scores
Z-scores (no unit) of anthropometric measures (weight for age, length for age, head circumference for age)
Measured: up to 16 weeks, depending on gestational age at birth
Stool consistency
Stool consistency (4-point scale Amsterdam stool scale: watery, soft, formed, hard)
Measured: up to 16 weeks, depending on gestational age at birth
Stool frequency
Stool frequency (number of stools per day)
Measured: up to 16 weeks, depending on gestational age at birth
Enteral intake
Total enteral intake (mL/kg/day)
Measured: up to 16 weeks, depending on gestational age at birth
vomiting
Incidence of vomiting (number/day)
Measured: up to 16 weeks, depending on gestational age at birth
Regurgitation
Incidence of regurgitation (number/day)
Measured: up to 16 weeks, depending on gestational age at birth
Enteral feed
Number of days that an infant is not fed enterally
Measured: up to 16 weeks, depending on gestational age at birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start8 Mar 2018
- Primary completion1 Jun 2020
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjects in Need of a Human Milk Fortifier (HMF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315221
- Sponsor's protocol ID
- EBB16GL06402
- Acronym
- Renoir
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2017
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40037774
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03315221
- Acronym / sponsor ID
- Renoir / EBB16GL06402
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Other: Test productHuman Milk Fortifier (HMF) with added lipids. |
| Control product | Active comparator | Other: Control productCommercially available HMF (without lipids). |
Who may qualify
- Ages
- 1 week to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test productHMF with added lipids - Intervention group | Other | Test product |
| Control productCommercially available HMF (without lipids) - control group | Other | Control product |
Primary outcome
Weight growth velocity
Time frame: 21 days
Weight growth velocity (in g/kg/day) from baseline to study day 21
10 secondary outcomes
Length
Time frame: up to 16 weeks, depending on gestational age at birth
Head circumference
Time frame: up to 16 weeks, depending on gestational age at birth
Weight for Length
Time frame: up to 16 weeks, depending on gestational age at birth
Z-scores
Time frame: up to 16 weeks, depending on gestational age at birth
Stool consistency
Time frame: up to 16 weeks, depending on gestational age at birth
Stool frequency
Time frame: up to 16 weeks, depending on gestational age at birth
Enteral intake
Time frame: up to 16 weeks, depending on gestational age at birth
vomiting
Time frame: up to 16 weeks, depending on gestational age at birth
Regurgitation
Time frame: up to 16 weeks, depending on gestational age at birth
Enteral feed
Time frame: up to 16 weeks, depending on gestational age at birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 40037774Picaud 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Test product in people with Subjects in Need of a Human Milk Fortifier (HMF) and Growth, run by Nutricia Research at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands, France, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight growth velocity (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.