EUCTR2011-005456-33-AT进行中（未招募）1 期
PREVENTING CHOLESTASIS IN PREMATURE INFANTS USING SMOFLIPID - Smoflipid
Med. Univ. Wien, Universitätsklinik für Kinder- und Jugendheilkunde0 个研究点目标入组 200 人开始时间: 2012年1月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- 性别
- All
入选标准
- •Infants born with a birth weight = 1000 Gram (= extreme low birth weight infants)
- •Admission to the neonatal ward in the first 24 hours of life
- •Informed consent obtained and randomized on study drug the first 5 days of life
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •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
- •Triplets or higher
- •Conjugated bilirubin > 1.5 mg/dl before inclusion to the study
- •Conditions associated with cholestasis independent of parenteral nutrition:
- •o Inborn errors of metabolism
- •o Viral Infections (cytomegaly virus, HIV, Hepatitis B, C)
- •o Immune mediated hemolytic diesease (e.g. Rhesus incompatibility)
- •o Cystic fibrosis
- •o Primary cholestatic diseases of the liver
研究者
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