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Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition (Purple-N)

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ClinicalTrials.gov Identifier: NCT03499288
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nutricia Research

Brief Summary:
HCPs will complete questionnaires about their patients with Cerebral Palsy (CP) and invite parents/caregivers of these patients to fill in questionnaires as well. Questionnaires include questions on individualized treatment, nutritional profile and management, and patient characteristics.

Condition or disease
Cerebral Palsy

Detailed Description:

Coordinating health care professionals (HCPs; e.g. paediatric neurologists, physiotherapists) in different centres across different countries will be asked to participate in this cross-sectional study.

A) for the HCP to fill out a questionnaire about their CP child, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status; and B) for parents (/legal representatives) to receive and fill out questionnaires about their CP child and themselves, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status, participation and (their own) quality of life.

If parents (/legal representatives) agree to "A)", but not "B)" then a subject will still enter the study, but without the parental assessment.


Study Type : Observational
Actual Enrollment : 499 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : July 3, 2018
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Children and youth with cerebral palsy
Subjects between 1 month and 18 years of age with Cerebral Palsy who visited the coordinating HCP within the past 12 months.



Primary Outcome Measures :
  1. Quantify current CP characteristics 1 (general subject characteristics): [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    - General subject characteristics (e.g. Sex, Birth weight [g], Type of CP motor disorder [category]


  2. Quantify current CP characteristics 2 (anthropometry): [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    Anthropometry: length [cm]; weight [grams] and BMI (kg/m2)


  3. Quantify current CP characteristics 3 (motor function) [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    Motor function (GMFCS [category]; GMFM measurement type [GMFM-86/GMFM-88]


  4. Quantify current CP characteristics 4 (comorbidities) [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    Comorbidities: epilepsy, cognitive function, GI problems [categories]


  5. Quantify current CP characteristics 5 (therapies) [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    Type and frequency of physical/occupational therapy [type, number of hours per day /days per week]


  6. Quantify current CP characteristics 6 (feeding mode) [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    Feeding mode and/or problems (tube feeding [yes/no], type of tube feeding etc)


  7. Quantify current CP characteristics 7 (nutritional status) [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]

    Using questionnaires to quantify current CP characteristics with respect to:

    Nutritional status (HCP and parent perspective on nutritional status, concerns [yes/no])



Other Outcome Measures:
  1. Quality of life and participation 1 [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]
    Questionnaire to assess Quality of Life of subjects with CP [scores on domains]

  2. Quality of life and participation 2 [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]
    Questionnaire to assess Quality of Life of parents (/legal representatives) of subjects with CP [scores on domains]

  3. Quality of life and participation 3 [ Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire ]
    Level of participation included in the general parent questionnaire [categories]



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects between 1 month and 18 years of age with Cerebral Palsy
Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of Cerebral Palsy
  2. Age<18 years
  3. Have visited the HCP within the last year
  4. Written informed consent provided by parents/legal representatives according to local law

Exclusion Criteria:

  1. Neurodegenerative diseases
  2. Acute infections: meningitis, encephalitis or poliomyelitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499288


Locations
Czechia
Fakultní nemocnice v Motole
Praha, Czechia
Greece
Attikon University General Hospital
Athens, Greece
Hungary
Bethesda Children Hospital Budapest
Budapest, Hungary
Italy
AO Sant'Orsola - Malpighi, Policlinico
Bologna, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milano, Italy
AOU di Modena - Policlinico
Modena, Italy
Netherlands
Roessingh centrum voor Revalidatie
Enschede, Netherlands
Poland
Medical university hospital of Gdansk
Gdańsk, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznań, Poland
Slovakia
Fakultná nemocnica Trnava
Trnava, Slovakia
Turkey
Ankara University School of Medicine/Neurology
Ankara, Turkey
Gazi University School of Medicine/Neurology
Ankara, Turkey
Hacettepe University School of Medicine/Neurology
Ankara, Turkey
Ege University School of Medicine/Neurology
Ege, Turkey
Eskisehir Osmangazi University School of Medicine/Neurology
Eskişehir, Turkey
Inonu University School of Medicine/Neurology
İnönü, Turkey
Dokuz Eylul University School of Medicine/Neurology
İzmir, Turkey
Marmara University School of Medicine/Neurology
Marmara, Turkey
Mersin University School of Medicine/Neurology
Mersin, Turkey
Sponsors and Collaborators
Nutricia Research

Responsible Party: Nutricia Research
ClinicalTrials.gov Identifier: NCT03499288     History of Changes
Other Study ID Numbers: MPR15FA89628
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nutricia Research:
Cerebral Palsy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases