Children not suffering from a special disease.
Conditions
Interventions
Group 1: 1 x 1 minitablet 2mm diameter per os
Group 2: 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 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.
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 investigate differences in the capability of children of six paediatric age groups to swallow two different oral placebo formulations. To investigate differences in the acceptability of two different oral placebo formulations in six paediatric age groups. 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 find out which of the two oral placebo formulations is the most suitable for each of the six age groups. To identify the differences in percentage of children in the different age groups who choke on any of the two oral placebo formulations. To identify the number of children who refuse to take an oral placebo formulation or 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 two oral placebo formulations. To investigate the safety of both oral placebo formulations. | — |
Countries
Germany
Contacts
Public ContactThomas Meissner
Universitätsklinik Düsseldorf Klinik für Allgemeine Pädiatrie
Outcome results
None listed