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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 : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 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
Estimated Enrollment : 500 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
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 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 [ 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
    • Anthropometry
    • Motor function
    • Co-morbidities (e.g. epilepsy)
    • Type and frequency of physical / occupational therapy
    • Feeding mode and / or problems
    • Nutritional status


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

  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

  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



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


Contacts
Contact: B Mourmans +31 30 209 5000 barbara.mourmans@danone.com

Locations
Czechia
Fakultní nemocnice v Motole Recruiting
Praha, Czechia
Contact: Josef Kraus         
Greece
Attikon University General Hospital Recruiting
Athens, Greece
Contact: Argirios Dinopoulos       argidino@yahoo.com   
Hungary
Bethesda Children Hospital Budapest Completed
Budapest, Hungary
Italy
AO Sant'Orsola - Malpighi, Policlinico Recruiting
Bologna, Italy
Contact: Duccio Cordelli       ducciomaria.cordelli@aosp.bo.it   
ASST degli Spedali Civili di Brescia Recruiting
Brescia, Italy
Contact: Elisa Fazzi       elisa.fazzi@unibs.it   
Fondazione IRCCS Istituto Neurologico "Carlo Besta" Recruiting
Milano, Italy
Contact: Giovanni Baranello       giovanni.baranello@istituto-besta.it   
AOU di Modena - Policlinico Recruiting
Modena, Italy
Contact: Azzurra Guerra       azzurra.guerra@unimore.it   
Netherlands
Roessingh centrum voor Revalidatie Recruiting
Enschede, Netherlands
Contact: Dea Schröder       d.schroder@roessingh.nl   
Poland
Medical university hospital of Gdansk Recruiting
Gdańsk, Poland
Contact: Maria Mazurkiewicz-Bełdzińska       mmazur@gumed.edu.pl   
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Recruiting
Poznań, Poland
Contact: Barbara Steinborn         
Contact       bstein@ump.edu.pl   
Slovakia
Fakultná nemocnica Trnava Recruiting
Trnava, Slovakia
Contact: Alena Pobiecka         
Turkey
Ankara University School of Medicine/Neurology Completed
Ankara, Turkey
Gazi University School of Medicine/Neurology Completed
Ankara, Turkey
Hacettepe University School of Medicine/Neurology Completed
Ankara, Turkey
Ege University School of Medicine/Neurology Completed
Ege, Turkey
Eskisehir Osmangazi University School of Medicine/Neurology Completed
Eskişehir, Turkey
Inonu University School of Medicine/Neurology Completed
İnönü, Turkey
Dokuz Eylul University School of Medicine/Neurology Completed
İzmir, Turkey
Marmara University School of Medicine/Neurology Completed
Marmara, Turkey
Mersin University School of Medicine/Neurology Completed
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: April 17, 2018
Last Verified: April 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