None. Only Placebo.
Conditions
Interventions
Group 1: One oblong-tablet and 3 ml glucose syrup in the order assigned by randomisation
Group 2: One oblong-tablet and three 2 mm mini-tablets in the order assigned by randomisation
Sponsors
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Age Children aged from 1 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 Based on medical history, physical examination and all other appropriate diagnostic procedures they are able to swallow. Participants suffering from illness must be able to swallow the three formulations and to accept the study procedures. This conclusion is based on medical history, physical examination and all other appropriate diagnostic procedures. 5. Compliance Participants and participants’ 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 study and have given written informed consent and assent where possible.
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. sepsis, respiratory distress, 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 drink and capable to follow the study-related instructions. 5. Nutrition Children, who have eaten one hour before examination and who afterwards feel sick.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate non-inferiority in acceptability of the oblong-tablet in comparison to 3 ml glucose syrup in children aged between 1 year and 5 years inclusive. Acceptability and Swallowability: Oblong-tablet and mini-tablets: • Swallowed o which implies that no chewing took place during deglutition and no residuals of the solid were found during oral inspection o interpreted as accepted and swallowed • Chewed o which implies that chewing was observed before deglutition or that the whole or parts of the solid were found during oral inspection o interpreted as accepted but not swallowed • Spat out o which means that no deglutition took place and that the solid is no longer in the child’s mouth o interpreted as not accepted and not swallowed • Choked on o which means that the solid was swallowed the wrong way or that a cough was caused o interpreted as not accepted and not swallowed • Refused to take o which implies that the child didn’t allow the investigator to place the solid in the mouth o interpreted as not accepted and not swallowed Glucose syrup: • Everything swallowed o which means that no liquid was left in the mouth and no drops left the mouth o interpreted as accepted and swallowed • Small runlet flowing out of the mouth or leftover in the syringe o which means that the child did not swallow completely o interpreted as accepted but not swallowed • Spat out o which means that no deglutition took place because the child disgorged the glucose syrup directly o interpreted as not accepted and not swallowed • Choke on o which means that the syrup was swallowed the wrong way or that a cough was caused o interpreted as not accepted and not swallowed • Refused to take o which implies that the child didn’t allow the investigator to place the syringe in the mouth or that the child didn’t close the mouth correctly and that all glucose syrup was leaking out of the mouth because no deglutition took place o interpreted as not accepted and not swallowed | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate non-inferiority in acceptability of the oblong-tablet in comparison to three mini-tablets in children aged between 1 year and 5 years inclusive. To compare swallowability of the oblong-tablet and of 3 ml glucose syrup in children aged between 1 year and 5 years inclusive. To compare swallowability of the oblong-tablet and of three mini-tablets in children aged between 1 year and 5 years inclusive. To compare acceptability of an oblong-tablet and of 3 ml glucose syrup in subsets of children aged 1 to 2 years, 2 to 3 years, 3 to 4 years, 4 to 5 years and 5 to 6 years. To compare acceptability of an oblong-tablet and of three mini-tablets in subsets of children aged 1 to 2 years, 2 to 3 years, 3 to 4 years, 4 to 5 years and 5 to 6 years. To compare swallowability of an oblong-tablet and of 3 ml glucose syrup in subsets of children aged 1 to 2 years, 2 to 3 years, 3 to 4 years,4 to 5 years and 5 to 6 years. To compare swallowability of an oblong-tablet and of three mini-tablets in subsets of children aged 1 to 2 years, 2 to 3 years, 3 to 4 years, 4 to 5 years and 5 to 6 years. To compare the palatability of an oblong-tablet, three mini-tablets and 3 ml syrup in each age group. To identify any possible problem that could occur during deglutition. To identify the percentage of children who inhaled or coughed during ingestion of any of the oral placebo formulations. To investigate the safety of the oral placebo formulations. To investigate the percentage of approached parents consenting to participation of their child in this study. To identify reasons why approached parents are not willing to agree to the participation of their child in this study. | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Heinrich-Heine Universität Düsseldorf
Outcome results
None listed