No specific disease. Placebo Administration to hospitalised patients.
Conditions
Interventions
Group 1: Each patient is assigned to one of the three age groups depending on the age. The sequence of the two administrations (orodispersible film and glucose sirup) is randomised.
Patients of age
Sponsors
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Eligibility
Sex/Gender
All
Age
2 Days to 12 Months
Inclusion criteria
Inclusion criteria: 1. Age Children aged from 2 days to 12 months inclusive 2. Sex Male or female 3. Recruitment Recruiting will take place in the Department of Obstetrics and Gynaecology of the University Hospital Düsseldorf as well as 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. Neonates are healthy and are not suffering from an illness. Based on medical history, physical examination and all other appropriate diagnostic procedures they are able to swallow the two formulations and to accept the study procedures. 5. Compliance Participant’s parents understand and are willing, able and likely to comply with examination procedures and restrictions. 6. Consent 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. Pre- and Concomitant Medication Any drug that causes nausea, fatigue or palsy 3. Intervention No examination shortly after surgical intervention until child is allowed to drink.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate non-inferiority in acceptability of an orodispersible film in comparison to an age adapted amount of glucose-syrup in children between 2 days and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare acceptability of an orodispersible film and of an age adapted amount of glucose-syrup in subsets of children aged 2 days to 28 days, 29 days to 5 months inclusive and 6 months to 12 months inclusive. To compare swallowability of an orodispersible film and of an age adapted amount of glucose-syrup in subsets of children aged 2 days to 28 days, 29 days to 5 months inclusive and 6 months to 12 months inclusive. To compare the palatability of an orodispersible film and syrup. 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 agreeing to the 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