Skip to main content
OpenTrials
Completed

NCT Number: 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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

1 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hôpital de la Croix Rousse, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Test Product

Other

HMF with added lipids - Intervention group

Control product

Other

Commercially available HMF (without lipids) - control group

Primary outcomes

  1. Weight growth velocity

    Time frame: 21 days

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

Secondary outcomes

  1. Length

    Time frame: up to 16 weeks, depending on gestational age at birth

    Length gain (cm/week)

  2. Head circumference

    Time frame: up to 16 weeks, depending on gestational age at birth

    Head circumference gain (cm/week)

  3. Weight for Length

    Time frame: up to 16 weeks, depending on gestational age at birth

    Weight for Length

  4. Z-scores

    Time frame: up to 16 weeks, depending on gestational age at birth

    Z-scores (no unit) of anthropometric measures (weight for age, length for age, head circumference for age)

  5. Stool consistency

    Time frame: up to 16 weeks, depending on gestational age at birth

    Stool consistency (4-point scale Amsterdam stool scale: watery, soft, formed, hard)

  6. Stool frequency

    Time frame: up to 16 weeks, depending on gestational age at birth

    Stool frequency (number of stools per day)

  7. Enteral intake

    Time frame: up to 16 weeks, depending on gestational age at birth

    Total enteral intake (mL/kg/day)

  8. vomiting

    Time frame: up to 16 weeks, depending on gestational age at birth

    Incidence of vomiting (number/day)

  9. Regurgitation

    Time frame: up to 16 weeks, depending on gestational age at birth

    Incidence of regurgitation (number/day)

  10. Enteral feed

    Time frame: up to 16 weeks, depending on gestational age at birth.

    Number of days that an infant is not fed enterally

Other outcomes

  1. Exploratory - Age

    Time frame: 2-16 weeks, depending on gestational age at birth

    Age at discharge from the neonatal intensive care unit (NICU, level III)

  2. Exploratory - Age

    Time frame: 4-16 weeks depending on gestational age at birth

    Age at discharge home

  3. Exploratory - Mortality

    Time frame: up to 16 weeks depending on gestational age at birth

    Mortality (yes/no) during stay in NICU/hospital

  4. Exploratory - Enteral feeding volume

    Time frame: around 1-4 weeks, depending on gestational age at birth

    Time in days to achieve an enteral feeding volume of at least 150 mL/kg/day +/- 10 mL for 3 consecutive days

  5. Exploratory - Gastric residuals

    Time frame: up to 16 weeks, depending on gestational age at birth

    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)

  6. Exploratory - Diarrhoea

    Time frame: up to 16 weeks, depending on gestational age at birth)

    Occurrence of diarrhoea

  7. Exploratory - Constipation

    Time frame: up to 16 weeks, depending on gestational age at birth)

    Occurrence of constipation

  8. Exploratory - Weight

    Time frame: at 6, 12 and 24 months corrected age (CA)

    Weight (g)

  9. Exploratory - Length

    Time frame: at 6, 12 and 24 months corrected age (CA)

    Length (cm)

  10. Exploratory - Head circumference

    Time frame: at 6, 12 and 24 months corrected age (CA)

    Head circumference (cm)

  11. Exploratory - Neurodevelopmental outcome

    Time frame: at 24 months CA

    Neurodevelopmental outcome assessed by Bayley Scales of Infant and Toddler Development, Third Edition, on three subscales (cognitive, fine and gross motor)

  12. Safety - Incidence (S)AE's

    Time frame: up to 24 months CA

    Incidence of (Serious) Adverse Events that are assessed by the Investigator to be possibly, probably or definitely related to the study product

  13. Safety - Frequency (S)AE's

    Time frame: up to 24 months CA

    Frequency of (Serious) Adverse Events that are assessed by the Investigator to be possibly, probably or definitely related to the study product

  14. Safety - Severity (S)AE's

    Time frame: up to 24 months CA

    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

  15. Safety - Relatedness (S)AE's

    Time frame: up to 24 months CA

    Relatedness of Serious Adverse Events

  16. Safety - Incidence Blood in stool

    Time frame: up to 16 weeks, depending on gestational age at birth)

    Incidence blood in stool

  17. Safety - Frequency Blood in stool

    Time frame: up to 16 weeks, depending on gestational age at birth)

    Frequency of blood in stool

  18. Safety - Severity Blood in stool

    Time frame: up to 16 weeks, depending on gestational age at birth)

    Severity of blood in stool (mild, moderate, severe)

  19. Safety - NEC

    Time frame: up to 16 weeks, depending on gestational age at birth)

    NEC (defined as Bell's stage two or higher) (as part of the assessment of neonatal morbidity)

  20. Safety - Bronchopulmonary dysplasia

    Time frame: up to 16 weeks, depending on gestational age at birth)

    Bronchopulmonary dysplasia (as part of the assessment of neonatal morbidity), categorized into mild/moderate/severe based on Sahni et al

  21. Safety - Serious neonatal infections

    Time frame: up to 16 weeks, depending on gestational age at birth

    Serious neonatal infections (as part of the assessment of neonatal morbidity), i.e. confirmed sepsis, pneumonia, or meningitis

  22. Safety - Retinopathy of Prematurity

    Time frame: up to 16 weeks, depending on gestational age at birth

    Retinopathy of Prematurity, based on International Committee for the Classification of Retinopathy of Prematurity (as part of the assessment of neonatal morbidity)

  23. Safety - Metabolic acidosis

    Time frame: up to 16 weeks, depending on gestational age at birth

    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)

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: Renoir

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Oct 20, 2017
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.