DRKS00021800已完成不适用
INTERNATIONAL STUDY ON MEDICINES ACCEPTABILITY IN THE PAEDIATRIC POPULATIONSub-study in the University Children´s Hospital Düsseldorf, Germany (DE) - Accept18 DE
niversitätsklinik Düsseldorf, Heinrich-Heine Universität Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie0 个研究点目标入组 360 人开始时间: 2020年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 18 Years（—）
- 性别
- All
入选标准
- •Patients < 18 years of age
- •Receiving any medicine by any route of administration, including those delivered via cannula provided that the cannula is inserted at the time of medicine administration.
- •Written informed consent from both parents or the legal guardian. They must understand the contents of the informed consent form, requirements of the study and have had an opportunity to review questions with a trained member of the site study team. It is not necessary that the second parent is personally present. The second informed consent can be obtained by telephone in presence of an independent witness.
- •Verbal or written age appropriate assent from the patient if able to give.
- •No limitations of nationalities, demographics, socio-economic groups, ethnic groups.
- •All participants contributing to the study must be able to read and understand German.
排除标准
- •Age >18 years of age
- •Parent/carer unable to read and/or understand the study information leaflet
- •Receiving intravenous medication where the intravenous device is already in situ – part of the acceptability will consider the insertion of such a device
- •Written consent not obtained from both parents
- •The patient is deemed unsuitable at the discretion of the investigator
- •Child participant does not assent verbally to participating in the study
- •Parent/carer or participant unable or unwilling to give consent
- •The treating clinical team feel there is pronounced family distress or child protection intervention that would make it inappropriate to approach the family to take part in the study
研究者
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