A randomised, double-blind study of the safety and efficacy of Neoven compared to Vaminolact in infants and children requiring long-term parenteral nutritio

Phase 1

• Conditions: 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 infants and children, when oral or enteral nutrition is impossible, insufficient or contraindicated.; MedDRA version: 12.1 Level: LLT Classification code 10051284 Term: Parenteral nutrition

• Registration Number: EUCTR2009-012604-92-FR
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-01
• Study Completion: 2011-02-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- Sex: Male or female
- Age: 1 month to 11 years
- Patients with intestinal malabsorption requiring parenteral nutrition (PN) at a minimum of 50% recommended daily amount (RDA) of total energy intake
- Expected stable disease requiring PN for at least 12 weeks such as short bowel syndrome, severe gastrointestinal obstruction, chronic intestinal pseudo obstruction, congenital enteropathy
- In case of PN infusion before inclusion: Permanent use of the same lipid emulsion for 16 weeks, starting 4 weeks prior to study inclusion and continued during study treatment period of 12 weeks
- Minimum of 4 days of PN infusion per week
- Legal representative(s) signed informed consent
- Assent obtained from patients above 7 years of age
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

- Absence of vascular access
- Patients requiring parenteral nutrition (PN) less than 50% RDA of total energy intake
- Insufficient renal function with serum creatinine of = 2.0 mg/dl (= 120µmol/L) or receiving dialysis/hemofiltration therapy
- Severe liver dysfunction (with either ammonia levels > 150 µmol/l or total S-Bilirubin > 200µmol/l and S-ALAT >200lU/l)
- Cirrhosis documented by histology
- Severe metabolic acidosis with Bicarbonate < 17 mmol/l, non-transient
- Inborn errors of amino acid metabolism
- Any other detectable metabolic disorders, if known at the time point of inclusion
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus with or without insulin treatment, severe sepsis and hypotonic dehydration)
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency.
- Thrombocytopenia: platelets <50x10^9/l
- Cancer, chemotherapy, radiation therapy
- Concomitant anticoagulant, steroid or immunosuppressive therapy
- Suspected allergy to the study medication
- Patients with psychiatric diseases, epilepsy
- Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study
- Prior inclusion in the present study
- Any other feature that in the opinion of the investigator should preclude study participation.

Study & Design

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