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

Prospective, Multicenter, Open-label, Randomized (1:1 Ratio), Controlled, Parallel Study Comparing Baxter Numeta G13%E to Compounded Parenteral Nutrition (cPN) Solution to Evaluate the Efficacy and Safety of Numeta G13%E in Preterm Neonates

Preterm (PT, born before 37 weeks of gestation) birth complications are the leading causes of death among children aged under 5 years globally, with nearly one million infant deaths reported in 2013. Preterm infants are born with limited nutrient stores, while birth occurs when the nutritional requirements are the highest in human life. Due to the immaturity of their gastrointestinal system, parenteral nutrition (PN) is usually required during the first weeks of life, especially in very low birth weight (VLBW) infants. Despite the availability of national and international guidelines, the initiation of PN is frequently not compliant with current recommendations, especially during the first days of life. In China, like in many other parts of the world, insufficient nutritional supply during hospital stay plays an important role in the postnatal growth restriction (PNGR) of PT infants. Several authors have recently shown that the use of standardized PN formulations can enable optimal early PN intake and can support improved growth rate without adverse consequences in PT infants. Guidelines recommend that standard PN solutions should generally be used over individualized PN solutions in the majority of pediatric and newborn patients, including VLBW infants. They also recommended that individually tailored PN solution should generally be used when the nutritional requirements cannot be met by the available range of standard PN formulations. Given the challenges of optimizing PN practice in PT infants, the aim of this study is to demonstrate non-inferiority of Numeta G13%E to classic compounding practice used for Chinese PT neonates. Please note: Secondary safety endpoints that include Adverse Events (AE) and abnormal blood results will be captured in AE section.

Inclusion Criteria:

• PT birth (>28 and < 37 weeks of gestation)
• Postnatal age < 48 hours
• Medical determination of PN requirement made by the attending physician in conjunction with the Investigator
• An anticipated PN duration after inclusion of at least 5 days
• Requirement for ≥ 80 % of energy intake from PN at inclusion (PN initiation)
• Written ICF signed by the patient's legal representative

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.