DRKS00000396已完成1 期
Exploratory, Randomized, Cross-over Physiological Examination of Capability to Swallow and Acceptability of Two Oral Placebo Formulations for Children of Six Different Age Groups
niversitätsklinik DüsseldorfKlinik für Allgemeine Pädiatrie0 个研究点目标入组 60 人开始时间: 2010年9月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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 5 Years（—）
- 性别
- All
入选标准
- •1. Age: Children aged from 0.5 to 5 years inclusive
- •2. Sex: Male and female
- •3. Recruiting: Recruiting will take place in the Paediatric Clinic of University Hospital Düsseldorf (inhouse and outpatient).
- •4. Health: Participants suffering from illness must be able to swallow in the opinion of the Principal Investigator based on medical history, physical examination and all other appropriate diagnostic 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. gastroenteritis, respiratory tract infection)
- •c)oral deformation
- •2. Intolerance: Lactose-Intolerance
- •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 eat and capable to follow the physiological examination-related instructions.
- •5. Nutrition: Children, who have eaten one hour before examination and who afterwards feel sick.
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