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

Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie0 个研究点目标入组 151 人开始时间: 2014年7月14日最近更新: 2024年8月19日

适应症

试验速览

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•Children aged from 2 to 28 days
•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).
•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.

•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

发起方

Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie