The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of parenteral nutrition for premature very low birth weight (VLBW) infants, when oral or enteral nutrition is impossible, insufficient or contraindicated. MedDRA version: 12.1 Level: LLT Classification code 10051284 Term: Parenteral nutrition
Conditions
Interventions
Product Name: NEOVEN
Product Code: NA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Acetylcysteine
CAS Number: 616-91-1
Current Sponsor code: N-Acetyl-L-Cysteine
Concentration unit:
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Sex: Male or female - Birth weight: 800 g - less than 1500 g - Gestational age: 25^0/7 - 31^6/7 weeks - Age: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe congenital malformations [like gastroschisis, omphalocele, a syndrome associated with (suspected) chromosomal anomalies, severe hydrops fetalis] - Insufficient renal function with serum creatinine of = 2.0 mg/dl (= 120 µmol/L) or receiving dialysis/hemofiltration therapy. - Severe liver dysfunction with either ammonia levels >150 µmol/l or direct bilirubin >8 mg/dl and ALT >200 IU/l - Severe congenital heart disease - Haematolytic disease and hyperbilirubinemia requiring exchange infusion - Oxygen saturation SpO2 < 80% for longer than two hours - Severe thrombocytopenia: platelets < 30x10^9/L - Administration of catecholamines except - low dose dopamine = 10 µg/kg bw/min and/or - dobutamine = 10 µg/kg bw/min or - adrenaline = 0.2 µg/kg bw/min - Congenital metabolic and/or endocrinologic disorders that affect energy and nutrient metabolism (e.g. errors of amino acid metabolism) - Severe metabolic acidosis (pH < 6.9 and base excess [BE = -15 mmol/L] after 6 hours of life) - Oral/enteral nutrition with more than 20% of total energy intake at the beginning of amino acid supplementation - Participation in another interventional clinical trial since birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to evaluate the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact in premature very low birth weight (VLBW) infants. The hypothesis of this study is that Neoven is non-inferior compared to Vaminolact. Non-inferiority for the primary endpoints in this study is defined as the lack of a pre-defined difference in specific primary safety endpoints (azotemia, metabolic acidosis, hyperammonemia, hyperaminoacidemia and hyperglycemia) between the two treatment groups.;Secondary Objective: Secondary objectives include safety and nutritional outcome parameters. Of specific importance are Anthropometry (weight, height), Time to full enteral feeding defined as > 120 ml / kg / day, Length of ICU stay, Mortality rate, Adverse Events, Infection rate including sepsis, Incidence of Necrotising Enterocolitis (NEC), Incidence of Broncho-Pulmonary Dysplasia (BPD) at 28 days and at 36 weeks of corrected age, Amino acid profiles, Mental and psychometric assessments including audiometry for otological disorders evaluation and Incidence of visual disorders especially fundoscopy for retinopathies. ;Primary end point(s): - Hyperammonemia - Metabolic acidosis - Azotemia - Hyperaminoacidemia - Hyperglycemia | — |
Countries
Germany, Netherlands
Outcome results
None listed