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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Human Milk Fortifier (HMF) with added lipids. |
|
| Control product | Active Comparator | Commercially available HMF (without lipids). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product | Other | HMF with added lipids - Intervention group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight growth velocity | Weight growth velocity (in g/kg/day) from baseline to study day 21 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Length gain (cm/week) | up to 16 weeks, depending on gestational age at birth |
| Head circumference | Head circumference gain (cm/week) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Age | Age at discharge from the neonatal intensive care unit (NICU, level III) | 2-16 weeks, depending on gestational age at birth |
| Exploratory - Age | Age at discharge home |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse | Lyon | France | ||||
| CHRU Nancy - Maternité regionale Universitaire A. Pinard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40037774 | Derived | 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. |
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| Control product |
| Other |
Commercially available HMF (without lipids) - control group |
|
| up to 16 weeks, depending on gestational age at birth |
| Weight for Length | Weight for Length | 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) | up to 16 weeks, depending on gestational age at birth |
| Stool consistency | Stool consistency (4-point scale Amsterdam stool scale: watery, soft, formed, hard) | up to 16 weeks, depending on gestational age at birth |
| Stool frequency | Stool frequency (number of stools per day) | up to 16 weeks, depending on gestational age at birth |
| Enteral intake | Total enteral intake (mL/kg/day) | up to 16 weeks, depending on gestational age at birth |
| vomiting | Incidence of vomiting (number/day) | up to 16 weeks, depending on gestational age at birth |
| Regurgitation | Incidence of regurgitation (number/day) | up to 16 weeks, depending on gestational age at birth |
| Enteral feed | Number of days that an infant is not fed enterally | up to 16 weeks, depending on gestational age at birth. |
| 4-16 weeks depending on gestational age at birth |
| Exploratory - Mortality | Mortality (yes/no) during stay in NICU/hospital | up to 16 weeks depending on gestational age at birth |
| Exploratory - Enteral feeding volume | Time in days to achieve an enteral feeding volume of at least 150 mL/kg/day +/- 10 mL for 3 consecutive days | around 1-4 weeks, depending on gestational age at birth |
| Exploratory - Gastric residuals | Frequency of clinically significant gastric residuals, defined as gastric residuals leading to a change in feeding according to the investigator's assessment (if assessed per local standard practice) | up to 16 weeks, depending on gestational age at birth |
| Exploratory - Diarrhoea | Occurrence of diarrhoea | up to 16 weeks, depending on gestational age at birth) |
| Exploratory - Constipation | Occurrence of constipation | up to 16 weeks, depending on gestational age at birth) |
| Exploratory - Weight | Weight (g) | at 6, 12 and 24 months corrected age (CA) |
| Exploratory - Length | Length (cm) | at 6, 12 and 24 months corrected age (CA) |
| Exploratory - Head circumference | Head circumference (cm) | at 6, 12 and 24 months corrected age (CA) |
| Exploratory - Neurodevelopmental outcome | Neurodevelopmental outcome assessed by Bayley Scales of Infant and Toddler Development, Third Edition, on three subscales (cognitive, fine and gross motor) | at 24 months CA |
| Safety - Incidence (S)AE's | Incidence of (Serious) Adverse Events that are assessed by the Investigator to be possibly, probably or definitely related to the study product | up to 24 months CA |
| Safety - Frequency (S)AE's | Frequency of (Serious) Adverse Events that are assessed by the Investigator to be possibly, probably or definitely related to the study product | up to 24 months CA |
| Safety - Severity (S)AE's | Severity of (Serious) Adverse Events (mild/moderate/severe) that are assessed by the Investigator to be possibly, probably or definitely related to the study product | up to 24 months CA |
| Safety - Relatedness (S)AE's | Relatedness of Serious Adverse Events | up to 24 months CA |
| Safety - Incidence Blood in stool | Incidence blood in stool | up to 16 weeks, depending on gestational age at birth) |
| Safety - Frequency Blood in stool | Frequency of blood in stool | up to 16 weeks, depending on gestational age at birth) |
| Safety - Severity Blood in stool | Severity of blood in stool (mild, moderate, severe) | up to 16 weeks, depending on gestational age at birth) |
| Safety - NEC | NEC (defined as Bell's stage two or higher) (as part of the assessment of neonatal morbidity) | up to 16 weeks, depending on gestational age at birth) |
| Safety - Bronchopulmonary dysplasia | Bronchopulmonary dysplasia (as part of the assessment of neonatal morbidity), categorized into mild/moderate/severe based on Sahni et al | up to 16 weeks, depending on gestational age at birth) |
| Safety - Serious neonatal infections | Serious neonatal infections (as part of the assessment of neonatal morbidity), i.e. confirmed sepsis, pneumonia, or meningitis | up to 16 weeks, depending on gestational age at birth |
| Safety - Retinopathy of Prematurity | Retinopathy of Prematurity, based on International Committee for the Classification of Retinopathy of Prematurity (as part of the assessment of neonatal morbidity) | up to 16 weeks, depending on gestational age at birth |
| Safety - Metabolic acidosis | Metabolic acidosis (as part of the assessment of neonatal morbidity) leading to correction and/or change in clinical management of the subject (according to the investigator's assessment) | up to 16 weeks, depending on gestational age at birth |
| 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 |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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