A Randomized, Single-dose, Cross-over Study to Investigate the Acceptability of an Orodispersible Film Compared to Syrup in Neonates and Infants
- Conditions
- o specific disease. Placebo Administration to hospitalised patients.
- Registration Number
- DRKS00011325
- Lead Sponsor
- Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 150
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. <br><br>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. <br><br>To compare the palatability of an orodispersible film and syrup.<br><br>To identify any possible problem that could occur during deglutition.<br><br>To identify the percentage of children who inhaled or coughed during ingestion of any of the oral placebo formulations. <br><br>To investigate the safety of the oral placebo formulations. <br><br>To identify the percentage of approached parents agreeing to the participation of their child in this study.<br><br>To identify reasons why approached parents are not willing to agree to the participation of their child in this study.<br>