Healthy neonates.
Conditions
Interventions
Group 1: Oral Placebo mini-tablet with a Diameter of 2mm. Single application.
Group 2: 0,5 mL oral Placebo Glucose-syrup. Single application.
Sponsors
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Eligibility
Sex/Gender
All
Age
2 Days to 28 Days
Inclusion criteria
Inclusion criteria: 1. Age Children aged from 2 to 28 days 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 Neonates are healthy and are not suffering from an illness. Based on medical history, physical examination and all other appropriate diagnostic procedures they are be able to swallow the two formulations. 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 study 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 prove that the suitability of the uncoated mini-tablet is not inferior to the suitability of the syrup in neonates between 2 and 28 days of age. Primary outcome: suitability (completely or partially swallowed). This Parameter was measured by Observation and oral inspection during and after the Intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify the percentage of neonates capable of swallowing a solid oral formulation. To investigate the differences in the deglutition of two different oral placebo formulations. To investigate the differences in the suitability of the uncoated mini-tablet versus the syrup. To prove that neonates are able to swallow a solid formulation as well as a liquid. To analyse the compliance of neonates requested to swallow a mini-tablet or glucose-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 two oral placebo formulations. To investigate the safety of the two 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. To identify the acceptability of the two oral placebo formulations. | — |
Countries
Germany
Contacts
Public ContactHans Martin Bosse
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed