A randomised, double-blind study evaluating the safety, tolerability and clinical outcome of Neoven compared to Vaminolact in premature ELBW infants

• 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 premature extreme low birth weight (ELBW) infants, when oral or enteral nutrition is impossible, insufficient or contraindicated.; MedDRA version: 12.1Level: LLTClassification code 10051284Term: Parenteral nutrition

• Registration Number: EUCTR2009-012603-26-DE
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-24
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

- Sex: Male or female
- Birth weight: = 1000 g
- Gestational age: = 29^6/7 weeks
- Age: < 48 hours after birth
- Life expectation should be at least 6 days as of start of PN
- Estimated requirement of parenteral nutrition (PN) including amino acids for at least 6 days
- Legal representative(s) signed and dated Informed Consent

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

- Severe congenital malformations [like gastroschisis, omphalocele, syndrome associated with (suspected) chromosomal anomalies, severe hydrops fetalis]
- Insufficient renal function with serum creatinine of = 2.0 mg/dL (= 177 µmol/L) or receiving dialysis/hemofiltration therapy.
- Severe liver dysfunction with either ammonia levels > 150 µmol/L or direct bilirubin > 8 mg/dL and alanine aminotransferase (ALT) > 200 lU/L.
- Severe congenital heart disease
- Haematolytic disease and hyperbilirubinemia requiring exchange infusion
- Oxygen saturation SpO2 < 80% for longer than two hours (without interruptions)
- 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

Study & Design

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