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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03499288
Other study ID # MPR15FA89628
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 11, 2017
Est. completion date July 3, 2018

Study information

Verified date November 2018
Source Nutricia Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 499
Est. completion date July 3, 2018
Est. primary completion date July 3, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Czechia Fakultní nemocnice v Motole Praha
Greece Attikon University General Hospital Athens
Hungary Bethesda Children Hospital Budapest Budapest
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
Netherlands Roessingh centrum voor Revalidatie Enschede
Poland Medical university hospital of Gdansk Gdansk
Poland Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Poznan
Slovakia Fakultná nemocnica Trnava Trnava
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 Eskisehir
Turkey Inonu University School of Medicine/Neurology Inönü
Turkey Dokuz Eylul University School of Medicine/Neurology Izmir
Turkey Marmara University School of Medicine/Neurology Marmara
Turkey Mersin University School of Medicine/Neurology Mersin

Sponsors (1)

Lead Sponsor Collaborator
Nutricia Research

Countries where clinical trial is conducted

Czechia,  Greece,  Hungary,  Italy,  Netherlands,  Poland,  Slovakia,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of life and participation 1 Questionnaire to assess Quality of Life of subjects with CP [scores on domains] Data collected retrospectively, from within 12 months of entering the questionnaire
Other Quality of life and participation 2 Questionnaire to assess Quality of Life of parents (/legal representatives) of subjects with CP [scores on domains] Data collected retrospectively, from within 12 months of entering the questionnaire
Other Quality of life and participation 3 Level of participation included in the general parent questionnaire [categories] Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 1 (general subject characteristics): 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]
Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 2 (anthropometry): Using questionnaires to quantify current CP characteristics with respect to:
Anthropometry: length [cm]; weight [grams] and BMI (kg/m2)
Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 3 (motor function) Using questionnaires to quantify current CP characteristics with respect to:
Motor function (GMFCS [category]; GMFM measurement type [GMFM-86/GMFM-88]
Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 4 (comorbidities) Using questionnaires to quantify current CP characteristics with respect to:
Comorbidities: epilepsy, cognitive function, GI problems [categories]
Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 5 (therapies) 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]
Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 6 (feeding mode) Using questionnaires to quantify current CP characteristics with respect to:
Feeding mode and/or problems (tube feeding [yes/no], type of tube feeding etc)
Data collected retrospectively, from within 12 months of entering the questionnaire
Primary Quantify current CP characteristics 7 (nutritional status) Using questionnaires to quantify current CP characteristics with respect to:
Nutritional status (HCP and parent perspective on nutritional status, concerns [yes/no])
Data collected retrospectively, from within 12 months of entering the questionnaire
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