Trial document





This trial has been registered retrospectively.
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  DRKS00005609

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

To investigate the suitability of uncoated mini-tablets in neonates in comparison to Glucose-syrup. Both formulations are Placebo.

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Organizational Data

  •   DRKS00005609
  •   2014/07/14
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  •   yes
  •   Approved
  •   3863, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy neonates.
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Interventions/Observational Groups

  •   Oral Placebo mini-tablet with a Diameter of 2mm. Single application.
  •   0,5 mL oral Placebo Glucose-syrup. Single application.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/05
  •   151
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   2   Days
  •   28   Days
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Additional 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.

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Dr. med  Hans Martin   Bosse 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Dr. med  Hans Martin  Bosse 
    • Moorenstr. 4
    • 40225  Düsseldorf
    • Germany
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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Dr. med  Hans Martin  Bosse 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Dr. med.  Hans Martin  Bosse 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/02/27
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.