No specific disease. Placebo Administration to hospitalised patients.
Conditions
Interventions
Group 1: Each patient is assigned to one of the two age groups depending on the age. The sequence of the three administrations (lower number of placebo mini-tablets, higher number of placebo mini-tabl
Sponsors
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Eligibility
Sex/Gender
All
Age
6 Months to 6 Years
Inclusion criteria
Inclusion criteria: 1. Age Children aged from 6 months to 5 years inclusive 2. Sex Male or female 3. Recruitment Recruiting will take place in the Paediatric Clinic of the University Hospital Düsseldorf, Germany (in-house patients and outpatients). 4. Health Children are under diagnostic procedures and/or treatment. Based on medical history, physical examination and all other appropriate diagnostic procedures they are able to swallow the three formulations and to accept the study 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. sepsis, respiratory distress, gastroenteritis, respiratory tract infection) c) oral deformation 2. Intolerance Lactose-Intolerance in family history 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate non-inferiority in suitability of 25 uncoated mini-tablets administered at a time in comparison to 5 ml glucose syrup in children between 6 months and 1 year inclusive. This outcome will be determined after one administration of mini-tablets and one administration of sirup and will be evaluated with predefined evaluationcriteria at the bedside. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate non-inferiority in suitability of 100 uncoated mini-tablets administered at a time in comparison to 5 ml glucose syrup in children between 6 months and 1year inclusive. To demonstrate non-inferiority in suitability of 100 uncoated mini-tablets administered at a time in comparison to 10 ml glucose syrup in children between 2 and 5 years inclusive. To demonstrate non-inferiority in suitability of 400 uncoated mini-tablets administered at a time in comparison to 10 ml glucose syrup in children between 2 and 5 years inclusive. To compare the capability of children between 6 months and 1 year inclusive to swallow 25 and 100 uncoated mini-tablets in comparison to 5 ml syrup. To compare the capability of children between between 2 and 5 years inclusive to swallow100 and 400 uncoated mini-tablets in comparison to 10 ml syrup. To identify the number of mini-tablets that young children are able to swallow. To identify the number of mini-tablets that young children are able to accept. To investigate the differences in the deglutition of multiple uncoated mini-tablets and syrup. To investigate the differences in the suitability of multiple uncoated mini-tablet versus the syrup. To prove that small children are able to swallow multiple solid formulation as well as a liquid. 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 identify the percentage of approached parents willing to participate in this study. To identify reasons why approached parents are not willing to participate in this study. | — |
Countries
Germany
Contacts
Public ContactHans Martin Bosse
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Outcome results
None listed