Trial document




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  DRKS00006831

Trial Description

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Title

Do children with a Pierre Robin Sequence have a worse speech development after cleft palate repair?

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Trial Acronym

PRS-Studie

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URL of the Trial

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Brief Summary in Lay Language

Children with a Pierre Robin Sequence (PRS) may have life threatening upper airway obstruction with a subsequent oxygen deficit and impaired neurological development. In the presence of a cleft palate speech development therefore seems to be worse compared to children with an isolated cleft. At the university hospital Tübingen a special intraoral appliance (baton plate) was developed to eliminate the airway obstruction in infants without any major burden. We expect, that the development of these children shoul be equal to otherwise healthy cleft palate children. This hypothesis shall be proved in a comparative study of these two groups. 40 children with isolated cleft palate and 20 children with PRS and cleft palate at the age of 5-6 years shall be included. They will be neurologically tested and their recorded speech samples will be blinded and evaluated.

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Brief Summary in Scientific Language

Children with a Pierre Robin Sequence (PRS) may have life threatening upper airway obstruction with a subsequent oxygen deficit and impaired neurological development. In the presence of a cleft palate speech development therefore seems to be worse compared to children with an isolated cleft. At the university hospital Tübingen a special intraoral appliance (baton plate) was developed to eliminate the airway obstruction in infants without any major burden. We expect, that the development of these children shoul be equal to otherwise healthy cleft palate children. This hypothesis shall be proved in a comparative study of these two groups. 40 children with isolated cleft palate and 20 children with PRS and cleft palate at the age of 5-6 years shall be included. They will be neurologically tested and their recorded speech samples will be blinded and evaluated.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006831
  •   2014/11/03
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  •   yes
  •   Approved
  •   586/2014BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   Q87.0 -  Congenital malformation syndromes predominantly affecting facial appearance
  •   Q35.5 -  Cleft hard palate with cleft soft palate
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Interventions/Observational Groups

  •   Children with cleft palate: Questionnaire about milestones in development, neuropsychological tests WPPSI-III and K-ABC-SED, neurological examination, audio and image recordings of speech on CD
  •   Children with cleft palate and PRS: Questionnaire about milestones in development, neuropsychological tests WPPSI-III and K-ABC-SED, neurological examination, audio and image recordings of speech on CD
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Speech function after surgery on cleft palates at the age of 5 – 6 years according to GOSSPASS list respectively universally reporting parameters for LKGS malformation.

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Secondary Outcome

1. Comparing neurologicals development (cognitive and motor development): Spastic, dyscinetic or atactic movement disorders defined in accordance with the SCPE-criteria, questionnaire about milestones in development on the study day (visit 1)
2. Growth of mandible and midface fixation (Assessment of the occlusion grade I-III according to Angle)
3. Number of remaining gaps in the palate

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/22
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   6   Years
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Additional Inclusion Criteria

Group 1: Patients with Piere Robin Sequenz and cleft palate
Group 2: Patients with isolated cleft palates
For both groups:
1. Ager: 5 years + 1 day to 6 years + 364 days (5 – 6 years)
2. Written approval by their legal guardians
3. cleft palate
4. Following surgery within the first 18 months of life.

In addition for group 1:
5. Supply of intraoral appliance (baton plate) to 1 year

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Exclusion Criteria

1. Comorbidities
2. Additional syndrome or sequences
3. Supply of intraoral appliance (baton plate) longer than 1 year

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Addresses

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    • Klinik und Poliklinik für Mund, Kiefer- und GesichtschirurgieUniversitätsklinikum Tübingen
    • Mr.  Prof. Dr. Dr.  Michael  Krimmel 
    • Osianderstr. 2-8
    • 72076  Tübingen
    • Germany
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    • Klinik und Poliklinik für Mund, Kiefer- und GesichtschirurgieUniversitätsklinikum Tübingen
    • Mr.  Prof. Dr. Dr.  Michael  Krimmel 
    • Osianderstr. 2-8
    • 72076  Tübingen
    • Germany
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    • Klinik und Poliklinik für Mund, Kiefer- und GesichtschirurgieUniversitätsklinikum Tübingen
    • Mr.  Dr.  Andreas  Naros 
    • Osianderstr. 2-8
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Margarete Müller-Bull-Stiftung
    • Mr.  Franz  Longin 
    • Gerokstr. 1
    • 70188  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/26
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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.