DRKS00011325已完成未知
A Randomized, Single-dose, Cross-over Study to Investigate the Acceptability of an Orodispersible Film Compared to Syrup in Neonates and Infants
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf0 个研究点目标入组 150 人开始时间: 2016年11月21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
- 150
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
- 2 Days 至 12 Months（—）
- 性别
- All
入选标准
- •Children aged from 2 days to 12 months inclusive
- •Male or female
- •3. Recruitment
- •Recruiting will take place in the Department of Obstetrics and Gynaecology of the
- •University Hospital Düsseldorf as well as in the Paediatric Clinic of the University
- •Hospital Düsseldorf, Germany (in-house patients and outpatients).
- •Children are under diagnostic procedures and/or treatment. Neonates are healthy and are not suffering from an illness. Based on medical history, physical examination and all other appropriate diagnostic procedures they are able to swallow the two formulations and to accept the study procedures.
- •5. Compliance
- •Participant’s parents understand and are willing, able and likely to comply with examination procedures and restrictions.
- •6. Consent
- •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. Pre- and Concomitant Medication
- •Any drug that causes nausea, fatigue or palsy
- •3. Intervention
- •No examination shortly after surgical intervention until child is allowed to drink.
研究者
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