Trial document




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  DRKS00005348

Trial Description

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Title

Opportunities for life in paeditric organ transplant recipients

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Trial Acronym

IFB-TX CORE 4

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to assess the consequences of pediatric organ failure and transplantation on the young person's neurological, cognitive, and social-emotional development. Furthermore we assess the quality of life of the young people concerned both from their own as well as from their parents' perspective. Finally we want to analyse the adherence of children with a lung transplant and whether this can be improved by intensified support via telephone between outpatients clinics.
Participants are children and adolescents age 0-16 with failure of kidney, liver, or lung who are in need of or have received a transplant.
We make use of the following methods and procedures: 1) neuropediatric assessment, 2) psychological interview, 3) developmental assessment, 4) neuropsychological testing where applicable 5) assessment of quality of life, 6) telephone counselling in support of outpatients care.

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Brief Summary in Scientific Language

The aim of this project is to:
1) enhance our understanding of the neuro-cognitive and developmental aspects of solid organ donation in paediatric patients.
2) identify predictors of neuro-cognitive outcome in paediatric solid organ transplant recipients.
3) describe the course of quality of life throughout the trajectory.
4) assess the need for intensified interventions in particular with regards to treatment adherence.
5) analyse the effectiveness of a programme involving regular / weekly patient contacts via phone to detect early signs of infection and rejection in lung transplant recipients, to increase treatment-adherence, and to reduce allograft-rejection and loss in function due to non-compliance.

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Organizational Data

  •   DRKS00005348
  •   2013/10/15
  •   [---]*
  •   yes
  •   Approved
  •   1878-2013 und 6509, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Z94.0 -  Kidney transplant status
  •   Z94.2 -  Lung transplant status
  •   Z94.4 -  Liver transplant status
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Interventions/Observational Groups

  •   young people with chronic kidney disease and kidney transplantation respectively


    Neuropaediatric examination according to a standardized age appropriate protocol (0-2yrs, 2-4yrs, above 4yrs)

    Neurocognitive assessment
    (re cognitive development / cognitive performance / IQ)
    - Bayley Scales III (age 0-3.5 yrs)
    - SON 2.5-7 (age 2.5-7)
    - WPPSI III (age 4-7.5)
    - WISC-IV (age 6-16)
    - SON-R 6-40 (age 6-40; non-verbal test)
    Choice of tool depends on child’s age and language skills

    Diagnostic psychological interviews (re psychological co-morbidity)
    - Strength and Difficulties Questionnaire (Screening tool)
    - DISYPS-KJ (structured interview)
    - Qualitative interview case-oriented

    Quality of Life assessment
    - KINDL (standardised questionnaire for children and their parents)
    - SF-36 ( standardised questionnaire for adults)

    assessment will be done when listed for transplantation and in yearly intervals up to two years after transplantation or until the end of the study periode
  •   young people with liver failure, chronic liver disease, and liver transplantation respectively


    Neuropaediatric examination according to a standardized age appropriate protocol (0-2yrs, 2-4yrs, above 4yrs)

    Neurocognitive assessment
    (re cognitive development / cognitive performance / IQ)
    - Bayley Scales III (age 0-3.5 yrs)
    - SON 2.5-7 (age 2.5-7)
    - WPPSI III (age 4-7.5)
    - WISC-IV (age 6-16)
    - SON-R 6-40 (age 6-40; non-verbal test)
    Choice of tool depends on child’s age and language skills

    Diagnostic psychological interviews (re psychological co-morbidity)
    - Strength and Difficulties Questionnaire (Screening tool)
    - DISYPS-KJ (structured interview)
    - Qualitative interview case-oriented

    Quality of Life assessment
    - KINDL (standardised questionnaire for children and their parents)
    - SF-36 ( standardised questionnaire for adults)

    assessment will be done when listed for transplantation and in yearly intervals up to two years after transplantation or until the end of the study periode
  •   young people with chronic lung failure and lung transplantation respectively


    Neuropaediatric examination according to a standardized age appropriate protocol (0-2yrs, 2-4yrs, above 4yrs)

    Neurocognitive assessment
    (re cognitive development / cognitive performance / IQ)
    - Bayley Scales III (age 0-3.5 yrs)
    - SON 2.5-7 (age 2.5-7)
    - WPPSI III (age 4-7.5)
    - WISC-IV (age 6-16)
    - SON-R 6-40 (age 6-40; non-verbal test)
    Choice of tool depends on child’s age and language skills

    Diagnostic psychological interviews (re psychological co-morbidity)
    - Strength and Difficulties Questionnaire (Screening tool)
    - DISYPS-KJ (structured interview)
    - Qualitative interview case-oriented

    Quality of Life assessment
    - KINDL (standardised questionnaire for children and their parents)
    - SF-36 ( standardised questionnaire for adults)

    assessment will be done when listed for transplantation and in yearly intervals up to two years after transplantation or until the end of the study periode

    In addition there will be an intensified follow-up after transplantation via telephone for 12 months
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

WHAT:
neurological functioning
via neuropediatric examination and neuro-motor testing

cognitive functioning (IQ-score)
via Bayleys III, WPPSI, WISC, SON

quality of life (test-score)
via KINDL and SF-36

incidence of psychological co-morbidity
via ICD-10 criteria

WHEN:
in yearly intervals after the child has been listed for transplantation

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Secondary Outcome

transplant functioning
measured by

kidney: GFR
liver: blood-levels / liver function test
lung: FEV1

plus intraindividual differences throughout the trajectory

in yearly intervals

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   16   Years
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Additional Inclusion Criteria

organ failure, transplantation

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Exclusion Criteria

no consent

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Addresses

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    • Medizinische Hochschule Hannover
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Jenny  Prüfe 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Jenny  Prüfe 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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