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

Phase 2

• Conditions: Subjects in Need of a Human Milk Fortifier (HMF); Growth; Safety; Tolerance
• Interventions: Other: Test product; Other: Control product

• Registration Number: NCT03315221
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Study Start: 2018-03-08
• Primary Completion: 2020-06-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test product	Test product	Human Milk Fortifier (HMF) with added lipids.
Control product	Control product	Commercially available HMF (without lipids).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Z-scores	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)
Stool consistency	up to 16 weeks, depending on gestational age at birth	Stool consistency (4-point scale Amsterdam stool scale: watery, soft, formed, hard)
Stool frequency	up to 16 weeks, depending on gestational age at birth	Stool frequency (number of stools per day)
Enteral intake	up to 16 weeks, depending on gestational age at birth	Total enteral intake (mL/kg/day)
vomiting	up to 16 weeks, depending on gestational age at birth	Incidence of vomiting (number/day)
Regurgitation	up to 16 weeks, depending on gestational age at birth	Incidence of regurgitation (number/day)
Enteral feed	up to 16 weeks, depending on gestational age at birth.	Number of days that an infant is not fed enterally
Length	up to 16 weeks, depending on gestational age at birth	Length gain (cm/week)
Head circumference	up to 16 weeks, depending on gestational age at birth	Head circumference gain (cm/week)
Weight for Length	up to 16 weeks, depending on gestational age at birth	Weight for Length

Trial Locations

Locations (15)

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; 🇩🇪 Nürnberg, Germany

Noordwest Ziekenhuisgroep; 🇳🇱 Alkmaar, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands

Flevoziekenhuis; 🇳🇱 Almere, Netherlands

Amsterdam UMC (VUMC); 🇳🇱 Amsterdam, Netherlands

OLVG Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Spaarne Ziekenhuis; 🇳🇱 Hoofddorp, Netherlands

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