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

Fresenius Kabi Deutschland GmbH0 个研究点目标入组 18 人开始时间: 2008年7月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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

发起方