Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition

Cerebral Palsy Clinical Trial

— Purple-N  

Official title:

A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499288
• Other study ID #: MPR15FA89628
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

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