A randomised, double-blind study evaluating the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact in premature very low birth weigth (VLBW) infants.

Phase 3

Completed

• Conditions: need for parenteral food; 10037008; need of food through infusion when feeding through the mouth is not posible

• Registration Number: NL-OMON34823
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

a) Sex: Male or female
b) Birth weight: 800 g - less than 1500 g
c) Gestational age: 250/7 - 316/7 weeks
d) Age: < 48 hours after birth
e) Life expectation should be at least 5 days as of start of PN
f) Estimated requirement of parenteral nutrition (PN) including amino acids for at least 5 days
g) Legal representative(s) signed and dated Informed Consent

Exclusion Criteria

a) Severe congenital malformations [like gastroschisis, omphalocele, a syndrome associated with (suspected) chromosomal anomalies, severe hydrops fetalis]
b) Insufficient renal function with serum creatinine of * 2.0 mg/dl (* 120 µmol/L) or receiving dialysis/hemofiltration therapy.
c) Severe liver dysfunction with either ammonia levels >150 *mol/l or direct bilirubin > 8 mg/dl and ALT >200 IU/l
d) Severe congenital heart disease
e) Haematolytic disease and hyperbilirubinemia requiring exchange infusion
f) Oxygen saturation SpO2 < 80% for longer than two hours
g) Severe thrombocytopenia: platelets < 30x109/L
h) 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
i) Congenital metabolic and/or endocrinologic disorders that affect energy and nutrient metabolism (e.g. errors of amino acid metabolism)
j) Severe metabolic acidosis (pH < 6.9 and base excess (BE < -15 mmol/L) after 6 hours of life
k) Oral/enteral nutrition with more than 20% of total energy intake at the beginning of amino acid supplementation
l) Participation in another interventional clinical trial since birth

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a) Hyperammonemia<br /><br>b) Metabolic acidosis<br /><br>c) Azotemia<br /><br>d) Hyperaminoacidemia<br /><br>e) Hyperglycemia</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a) Anthropometry (weight, crown-heel length, head circumference)<br /><br>b) Time to full enteral feeding defined as > 120 ml / kg / day<br /><br>c) Length of ICU stay<br /><br>d) Mortality rate<br /><br>e) Adverse events<br /><br>f) Infection rate including sepsis, for definition see appendix 3<br /><br>g) Incidence of Necrotising Enterocolitis (NEC), BELL stage > grade II defined<br /><br>by Bell et al 1978<br /><br>h) Incidence of Broncho-Pulmonary Dysplasia (BPD) at 28 days and at 36 weeks of<br /><br>corrected age as defined in appendix 7<br /><br>(Jobe et al 2001)<br /><br>i) Amino acid profiles<br /><br>j) Mental and psychometric assessments including audiometry for otological<br /><br>disorders evaluation<br /><br>k) Incidence of visual disorders especially fundoscopy for retinopathies,<br /><br>retinopathy of prematurity > grade III</p><br>