EUCTR2018-004946-41-IT进行中（未招募）1 期
Personalized Versus Standardized Parenteral Nutrition for Preterm Infants With a Birth Weight Greater Than 1250 Grams: a Multicenter Randomized Phase IV Clinical Trial - SPN vs PPN in preterm infants
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •- Birth weight > 1250 grams,
- •- Gestational age at birth between 27.0 and 36.6 weeks,
- •- need of parenteral nutrition,
- •- 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
- •- genetic, metabolic or endocrine disorders before/after enrolment;
- •- drug therapy with ceftriaxone or cumarina before/after enrolment;
- •- drug therapy with calcium before enrolment;
- •- cholestasis or hepatic insufficiency before enrolment;
- •- renal insufficiency before enrolment;
- •- hyponatremia before enrolment;
- •- hyperlipidemia/hypertriglyceridemia before enrolment;
- •- any hypersensitivity to the compounds of the study parenteral bags before/after enrolment;
- •- drug therapy with off-label drugs before/after enrolment;
- •- lacking informed consent.
研究者
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