All paediatric patients who present to the Clinic for General Paediatrics, Neonatology and Paediatric Cardiology at the University Hospital Düsseldorf as outpatients or inpatients and who are able to swallow.
Conditions
Interventions
Group 1: Children aged 1 - <6 months, receiving 3 mini-tablets and 1 ml glucose syrup in randomized order.
Group 2: Children aged 6 - <12 years, receiving 3 out of 4 formulations in a randomized order
Sponsors
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Eligibility
Sex/Gender
All
Age
1 Months to 17 Years
Inclusion criteria
Inclusion criteria: Age: Children aged from 1 - <6 months and from 6 - <18 years Sex: Male and female Health: Participants suffering from illness must be able to swallow the oral formulations and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures. Compliance: Participants and participants’ parents understand and are willing, able, and likely to comply with examination procedures and restrictions. 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: Disease/Illness: Any impairment of swallowing solids and liquids as a consequence of chronic illness (e.g. cerebral palsy), acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory tract infection), or oral deformation, as assessed by the investigator Intolerance: Lactose intolerance Pre- and Concomitant Medication: Any drug that causes nausea, fatigue, or palsy Intervention: Children in the post-operative period who have yet to commence regular oral feeding Nutrition: Children, who have eaten 1 hour before examination and who afterwards feel sick because of the food
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate a composite endpoint for acceptability evaluation (combination of palatability and deglutition scores) of 4 oral drug formulations in a paediatric population of different age groups that have so far not yet been investigated with the deglutition and palatability assessment method published by Klingmann et al. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To investigate the acceptability, swallowability and palatability of 3 mini-tablets in comparison to 1 mL glucose-syrup in children aged 1- <6 months - To investigate the acceptability, swallowability, and palatability of 11 mini-tablets in comparison to 9 mL glucose-syrup, round tablets and oblong tablets in children aged 6 - <12 years - To investigate the acceptability, swallowability and palatability of 70 mini-tablets in comparison to 18 mL glucose-syrup, round tablets, and oblong tablets in children aged 12 - <18 years - 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 different formulations | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Universitätsklinik Düsseldorf, Heinrich-Heine Universität Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed