Status:
COMPLETED
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Lead Sponsor:
Nutricia Research
Conditions:
Subjects in Need of a Human Milk Fortifier (HMF)
Growth
Eligibility:
All Genders
1-32 years
Phase:
PHASE2
PHASE3
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. Pre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT03315221
Start Date
March 8 2018
End Date
September 21 2022
Last Update
September 26 2024
Active Locations (15)
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1
Hôpital de la Croix Rousse
Lyon, France
2
CHRU Nancy - Maternité regionale Universitaire A. Pinard
Nancy, France
3
Universitätskinderklinik der Otto-v.-Guericke Universität
Magdeburg, Germany
4
Klinikum Nürnberg Süd
Nuremberg, Germany