A Randomized, Single-dose, Cross-over Study to Investigate the Suitability of Multiple Placebo Mini-tablet Administration in Small Childre

Not Applicable

• Conditions: o specific disease. Placebo Administration to hospitalised patients.

• Registration Number: DRKS00008843
• Lead Sponsor: Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-29
• Study Completion: 2016-01-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 374

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>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.