Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates

Exclusion Criteria

• •Neonates born \< 28 and ≥ 37 weeks of gestation
• •Neonates with a life expectancy \<1 week, which means with very severe critical illness implying foreseeable intercurrent events that could jeopardize the subject's primary outcome assessment including neonates with severe septic shock;
• •Neonates requiring or anticipated to undergo extracorporeal membrane oxygenation treatment;
• •Neonates with inborn error of metabolism including congenital abnormality of the amino acid metabolism or a family history of such disease;
• •Neonates with hyperkalemia \> 5.5 mmol/L at inclusion
• •Neonates with known severe pathologically elevated plasma concentrations of electrolyte at inclusion including hyperchloridemia \> 120 mmol/L;
• •Neonates with known severe hyperglycemia \>13.9 mmol/L (250 mg/dL) at inclusion;
• •Neonates with demonstrated severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia \> 4.5 mmol/L (400 mg/dL) at inclusion;
• •Neonates with known severe liver failure including plasma ALT (GPT) concentration \> 2 times the upper reference limit or conjugated (direct) bilirubin \> 34 µmol/L (\> 2 mg/dL) at inclusion;
• •Neonates with anuria and known severe renal disorder including plasma creatinine concentration \> 2 times the upper reference limit at inclusion;
• •Neonates with bleeding and severe coagulation disorders including platelet count \< 20×109/L at inclusion;
• •Neonates with general contraindications to infusion therapy: acute pulmonary edema, overhydration;
• •Neonates with known allergy to egg, soy bean or peanut proteins or to any of their active ingredients or excipients;
• •Neonates undergoing concomitant treatment with ceftriaxone, even if separate infusion lines are used;
• •Neonates undergoing participation in another investigational clinical study at study enrollment.