Exploratory, Randomized, Cross-over Physiological Examination of Capability to Swallow and Acceptability of Two Oral Placebo Formulations for Children of Six Different Age Groups
- Conditions
- Children not suffering from a special disease.
- Registration Number
- DRKS00000396
- Lead Sponsor
- niversitätsklinik DüsseldorfKlinik für Allgemeine Pädiatrie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate differences in the capability of children of six paediatric age groups to swallow two different oral placebo formulations.<br><br>To investigate differences in the acceptability of two different oral placebo formulations in six paediatric age groups.<br><br>These parameters are collected right after oral application by oral inspection.
- Secondary Outcome Measures
Name Time Method To prove that children are able to swallow a solid formulation as well as a liquid.<br><br>To find out which of the two oral placebo formulations is the most suitable for each of the six age groups.<br><br>To identify the differences in percentage of children in the different age groups who choke on any of the two oral placebo formulations. <br><br>To identify the number of children who refuse to take an oral placebo formulation or spit it out.<br><br>To identify any possible problem, that could occur during deglutition.<br><br>To show that children beginning at the age of six months are capable of swallowing a solid oral formulation.<br><br>To analyse the compliance of children requested to swallow a minitablet or glucose-syrup.<br><br>To identify the difference in palatability of the two oral placebo formulations.<br>To investigate the safety of both oral placebo formulations. <br>