Children not suffering from a special disease.
Conditions
Interventions
Group 1: 1 x 1 uncoated minitablet 2mm diameter per os
Group 2: 1 x 1 coated minitablet 2mm diameter per os
Group 3: 1 x 3ml glucose-syrup per os
Sponsors
Universitätsklinik Düsseldorf
Klinik für Allgemeine Pädiatrie
Eligibility
Sex/Gender
All
Age
6 Months to 5 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prove that the acceptability of the uncoated minitablet is superior to the acceptability of the syrup in the group of children between 0.5 and 5 years inclusive. These parameters are collected right after oral application by oral inspection. | — |
Secondary
| Measure | Time frame |
|---|---|
| To prove that children are able to swallow a solid formulation as well as a liquid. To investigate the differences in the acceptability of the uncoated minitablet versus the syrup in each age group. To investigate the differences in the acceptability of the coated minitablet versus the uncoated minitablet in each age group as well as for the whole population. To investigate the differences in the acceptability of the coated minitablet versus the syrup in each age group as well as for the whole population. To investigate the differences in the capability to swallow three different oral placebo formulations in each age group as well as in the whole population. To identify the differences in percentage of children in the different age groups who choke on any of the three oral placebo formulations. To identify the number of children who refuse to take an oral placebo formulation or who spit it out. To identify any possible problem, that could occur during deglutition. To show that children beginning at the age of six months are capable of swallowing a solid oral formulation. To analyse the compliance of children requested to swallow a minitablet or glucose-syrup. To identify the difference in palatability of the three oral placebo formulations. To investigate the safety of all oral placebo formulations. | — |
Countries
Germany
Contacts
Public ContactThomas Meissner
Universitätsklinik Düsseldorf Klinik für Allgemeine Pädiatrie
Outcome results
None listed