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

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.