A Randomized, prospective cross-over Study to Investigate the suitability and capability to swallow two oral placebo formulations in neonates

Not Applicable

• Conditions: Healthy neonates.

• Registration Number: DRKS00005609
• Lead Sponsor: Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-02-27
• Study Start: 2014-07-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 151

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

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 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.<br>Primary outcome: suitability (completely or partially swallowed).<br>This Parameter was measured by Observation and oral inspection during and after the Intervention.