Randomized, Cross-over Physiological Examination of Acceptability and Capability to Swallow Three Oral Placebo Formulations for Children of Six Different Age Groups

niversitätsklinik DüsseldorfKlinik für Allgemeine Pädiatrie0 个研究点目标入组 306 人开始时间: 2011年4月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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 like 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.

•1. Disease/Illness: Any impairment of swallowing either solids or glucose-syrup as a consequence
•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

发起方

niversitätsklinik DüsseldorfKlinik für Allgemeine Pädiatrie