DRKS00008843已完成未知
A Randomized, Single-dose, Cross-over Study to Investigate the Suitability of Multiple Placebo Mini-tablet Administration in Small Children
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf0 个研究点目标入组 374 人开始时间: 2015年6月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 374
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Months 至 6 Years（—）
- 性别
- All
入选标准
- •Children aged from 6 months to 5 years inclusive
- •Male or female
- •3. Recruitment
- •Recruiting will take place in the Paediatric Clinic of the University Hospital Düsseldorf, Germany (in-house patients and outpatients).
- •Children are under diagnostic procedures and/or treatment. Based on medical history, physical examination and all other appropriate diagnostic procedures they are able to swallow the three formulations and to accept the study procedures.
- •5. Compliance
- •Participant and participant’s parents understand and are willing, able and likely to comply with examination procedures and restrictions.
- •6. Consent
- •Participant and/or participant’s parents are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this physiological examination and have given written informed consent.
排除标准
- •1. Disease/Illness
- •Any impairment of swallowing either solids or glucose-syrup as a consequence of
- •a)chronic illness (e.g. cerebral palsy)
- •b)acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory tract infection)
- •c)oral deformation
- •2. Intolerance
- •Lactose-Intolerance in family history
- •3. Pre- and Concomitant Medication
- •Any drug that causes nausea, fatigue or palsy
- •4. Intervention
- •No examination shortly after surgical intervention until child is allowed to drink
研究者
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