EUCTR2017-002724-25-DK进行中（未招募）1 期
Intravenous and oral paracetamol in neonates: safety and ethanol-drug interactions – the PARASHUTE Trial - PARASHUTE trial
Helle Holst0 个研究点目标入组 120 人开始时间: 2017年7月7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
- 120
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
- •Neonates any gestational age and weight of both genders
- •Post menstrual age up to 44 full weeks at inclusion
- •Intended treatment with i.v. paracetamol for any indication or intended treatment with p.o. paracetamol for one of the following indications: fractures, cranial haemorrhages, chest tubes, postoperative pain or painfull skin lessions.
- •Informed written consent from both parents or legal guardian, Informed Consents must be approved by the Danish Ethical Committee
- •Signing consent form can be postponed 24 hours after treatment start
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •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
- •The responsible clinicians finds the patient unsuitable for trial
- •Hypersensitivity towards paracetamol
研究者
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