A randomised, double-blind study evaluating the safety, tolerability, and amino acid plasma levels of Neoven compared to Vaminolact in infants after surgical interventions.

• Conditions: 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: 9.1Level: LLTClassification code 10051284Term: Parenteral nutrition

• Registration Number: EUCTR2008-000429-20-DE
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-08
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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

•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 (including Downs syndrome) 1)
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified