Dietary Protein in the Very-low-birth-weight Infant

• Gestational age \<32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof
• Birth weight ≤1500 g
• Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h
• Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved
• In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl
• Written informed consent has been obtained from the legal representative

Exclusion Criteria:

• Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days
• Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography
• Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine
• Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture
• Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3)
• Hepatic dysfunction: defined by jaundice (direct bilirubin >1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT)
• Lung disease, severe enough to require steroid therapy.
• Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age.
• Participation in another clinical trial that may affect outcomes of this study