The product is aimed to be used where parenteral nutrition is required. The indended indication is: Supply of essential and non-essential amino acids as part of parenteral nutrition for preterm and fullterm neonates, infants and children, when oral or enteral nutrition is impossible, insufficient or contraindicated. MedDRA version: 9.1 Level: LLT Classification code 10051284 Term: Parenteral nutrition
Conditions
Interventions
Product Name: Neoven
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Acetylcysteine
CAS Number: 616-91-1
Current Sponsor code: N-Acetyl-L-Cysteine
Concentration unit: g/l gram(s)/litre
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Newborn infants, infants and toddlers after surgical interventions of the GI tract due to congenital malformations •Estimated need of parenteral amino acid intake for a minimum of 5 to 7 days •Age: Birth up to 23 months •Gestational age = week 34 1) •Birth weight for newborns = 1840 g 1) or within +/- 2 SD for standard weight (age and height adjusted) for infants other than newborns 3) •Males and females •Willingness of the legal representative(s) to participate as indicated by a writ-ten informed consent 2) 1) Especially infants with gastroschisis are frequently born in gestational age 34 and following few weeks. According to British data the 10% percentile of weight is 1840g. 2) standard inclusion criteria in clinical trials 3) to exclude severe growth retarded infants Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Enteral/oral nutrition = 25% of total energy intake 1) •significant impairment of renal function with serum creatinine of = 2.0 mg/dl (= 176 µmol/L) 1) •inborn congenital malformation other than the bowel 1) •severe congenital heart disease 1) •major chromosomal abnormalities 1) (including Downs syndrome) •inborn metabolic disorders, if known at the time point of inclusion 1) •severe liver dysfunction (with either ammonia levels > 150 µmol/l, INR > 2 or at least 2 liver enzyme parameters (ALT, AST, gGT, AP) > 3 fold upper limit of normal) 1) •Participation in another clinical trial within the last 4 weeks 2) 1) All these exclusion criteria have been set because of otherwise significant bias of the primary target variable. 2) standard exclusion criteria in clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will compare the safety of Neoven vs. Vaminolact as part of a paediatric parenteral nutrition regimen in infants after surgical interventions due to congenital gastro-intestinal malformations. The primary objective of the study is to compare the profile of all amino acids after last treatment (maximum Day 10). Neoven should demonstrate non-inferiority in terms of achieving plasma concentrations as much as possible in the middle of normal ranges. ;Secondary Objective: Secondary objectives include safety and nutritional outcome parameters. Of specific importance are liver function parameters with specific emphasis on cholestasis, metabolic acidosis with specific emphasis on bicarbonate levels, hypo-/hyperglycemia, plasma concentrations of the dipeptides Ala-Gln and Gly-Tyr, weight, head circumference, pre-albumin levels in plasma, incidence of sepsis/septicaemia and Adverse Events.;Primary end point(s): Profile of all amino acids in plasma; and comparison between the groups. The amino acid (AA) plasma concentrations will be determined at baseline, Day 7 and after last treatment (maximum Day 10, primary endpoint). For each of 21 relevant AAs, the relative difference to the midpoint of the normal range will be computed, and the absolute change (difference at baseline compared to difference after last treatment) will be generated. Then the sum of all 21 changes will be computed. The main focus in the statistical analysis will be to compare the mean sum of the Neoven group with the mean sum of the Vaminolact group. | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed