A randomised, double-blind study evaluating the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact(R) in premature very low birth weight (VLBW) 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 very low birth weight (VLBW) infants, when oral or enteral nutrition is impossible, insufficient or contraindicated.; MedDRA version: 12.1Level: LLTClassification code 10051284Term: Parenteral nutrition

• Registration Number: EUCTR2009-012602-39-DE
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

- Sex: Male or female
- Birth weight: 800 g - less than 1500 g
- Gestational age: 25^0/7 - 31^6/7 weeks
- Age: < 48 hours after birth
- Life expectation should be at least 5 days as of start of PN
- Estimated requirement of parenteral nutrition (PN) including amino acids for at least 5 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, a syndrome associated with (suspected) chromosomal anomalies, severe hydrops fetalis]
- Insufficient renal function with serum creatinine of = 2.0 mg/dl (= 120 µmol/L) or receiving dialysis/hemofiltration therapy.
- Severe liver dysfunction with either ammonia levels >150 µmol/l or direct bilirubin >8 mg/dl and ALT >200 IU/l
- Severe congenital heart disease
- Haematolytic disease and hyperbilirubinemia requiring exchange infusion
- Oxygen saturation SpO2 < 80% for longer than two hours
- 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