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

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT03499288
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-04-11
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantify current CP characteristics 7 (nutritional status)	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 \[yes/no\])
Quantify current CP characteristics 1 (general subject characteristics):	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 \[category\]
Quantify current CP characteristics 2 (anthropometry):	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)
Quantify current CP characteristics 3 (motor function)	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 \[GMFM-86/GMFM-88\]
Quantify current CP characteristics 4 (comorbidities)	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 \[categories\]
Quantify current CP characteristics 5 (therapies)	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 \[type, number of hours per day /days per week\]
Quantify current CP characteristics 6 (feeding mode)	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)

Trial Locations

Locations (20)

Bethesda Children Hospital Budapest; 🇭🇺 Budapest, Hungary

Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu; 🇵🇱 Poznań, Poland

Ankara University School of Medicine/Neurology; 🇹🇷 Ankara, Turkey

Medical university hospital of Gdansk; 🇵🇱 Gdańsk, Poland

Inonu University School of Medicine/Neurology; 🇹🇷 İnönü, Turkey

AO Sant'Orsola - Malpighi, Policlinico; 🇮🇹 Bologna, Italy

Fondazione IRCCS Istituto Neurologico "Carlo Besta"; 🇮🇹 Milano, Italy

AOU di Modena - Policlinico; 🇮🇹 Modena, Italy

Eskisehir Osmangazi University School of Medicine/Neurology; 🇹🇷 Eskişehir, Turkey

Marmara University School of Medicine/Neurology; 🇹🇷 Marmara, Turkey

ASST degli Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Ege University School of Medicine/Neurology; 🇹🇷 Ege, Turkey

Fakultní nemocnice v Motole; 🇨🇿 Praha, Czechia

Fakultná nemocnica Trnava; 🇸🇰 Trnava, Slovakia

Roessingh centrum voor Revalidatie; 🇳🇱 Enschede, Netherlands

Dokuz Eylul University School of Medicine/Neurology; 🇹🇷 İzmir, Turkey

Mersin University School of Medicine/Neurology; 🇹🇷 Mersin, Turkey

Attikon University General Hospital; 🇬🇷 Athens, Greece

Gazi University School of Medicine/Neurology; 🇹🇷 Ankara, Turkey

Hacettepe University School of Medicine/Neurology; 🇹🇷 Ankara, Turkey