EUCTR2009-012603-26-BE进行中（未招募）1 期
A randomised, double-blind study evaluating the safety, tolerability and clinical outcome of Neoven compared to Vaminolact in premature ELBW infants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 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
排除标准
- •- 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 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
研究者
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