Clinical trial NCT03499288: Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition
Official title: A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 499
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects between 1 month and 18 years of age with Cerebral Palsy

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.

Eligibility 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

Primary outcomes:
measure: Quantify current CP characteristics 1 (general subject characteristics):
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quantify current CP characteristics 2 (anthropometry):
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quantify current CP characteristics 3 (motor function)
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quantify current CP characteristics 4 (comorbidities)
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quantify current CP characteristics 5 (therapies)
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quantify current CP characteristics 6 (feeding mode)
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quantify current CP characteristics 7 (nutritional status)
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
Secondary outcomes:
Other outcomes:
measure: Quality of life and participation 1
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quality of life and participation 2
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
measure: Quality of life and participation 3
timeFrame: Data collected retrospectively, from within 12 months of entering the questionnaire
Locations:
city: Praha
country: Czechia
facility: Fakultní nemocnice v Motole
city: Athens
country: Greece
facility: Attikon University General Hospital
city: Budapest
country: Hungary
facility: Bethesda Children Hospital Budapest
city: Bologna
country: Italy
facility: AO Sant'Orsola - Malpighi, Policlinico
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"
city: Modena
country: Italy
facility: AOU di Modena - Policlinico
city: Enschede
country: Netherlands
facility: Roessingh centrum voor Revalidatie
city: Gdańsk
country: Poland
facility: Medical university hospital of Gdansk
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Trnava
country: Slovakia
facility: Fakultná nemocnica Trnava
city: Ankara
country: Turkey
facility: Ankara University School of Medicine/Neurology
city: Ankara
country: Turkey
facility: Gazi University School of Medicine/Neurology
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine/Neurology
city: Ege
country: Turkey
facility: Ege University School of Medicine/Neurology
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University School of Medicine/Neurology
city: İnönü
country: Turkey
facility: Inonu University School of Medicine/Neurology
city: İzmir
country: Turkey
facility: Dokuz Eylul University School of Medicine/Neurology
city: Marmara
country: Turkey
facility: Marmara University School of Medicine/Neurology
city: Mersin
country: Turkey
facility: Mersin University School of Medicine/Neurology
Study officials:
References:
citation: Fogarasi A, Fazzi E, Smorenburg ARP, Mazurkiewicz-Beldzinska M, Dinopoulos A, Pobiecka A, Schroder-van den Nieuwendijk D, Kraus J, Tekgul H; PURPLE N study group; Czech Republic:; Kraus J; Greece:; Dinopoulos A, Koutsaki M; Hungary:; Fogarasi A; Italy:; Baranello G, Bertoli S, Caramaschi E, Cordelli DM, De Amicis R, Fazzi E, Forchielli ML, Guerra A, Lividini A, Marchio M, Rossi A; Netherlands:; Nieuwendijk DSD; Poland:; Flicinski J, Gurda B, Lemska A, Matheisel A, Mazurkiewicz-Beldzinska M, Niwinska Z, Pawlowicz M, Sawicka A, Steinborn B, Szmuda M, Winczewska-Wiktor A, Zawadzka M; Slovakia:; Pobiecka A; Turkey:; Arhan E, Aydin K, Bayram E, Carman KB, Edem P, Ertem D, Goktas OA, Gungor S, Haliloglu G, Kansu A, Komur M, Mutlu A, Kirsaclioglu CT, Okuyaz C, Ozgor B, Ozturk Y, Sager SG, Sarigecili E, Selimoglu MA, Serin HMO, Teber ST, Tekgul H, Thomas G, Turkdogan D, Volkan B, Yarar C, Yilmaz SK. The PURPLE N study: objective and perceived nutritional status in children and adolescents with cerebral palsy. Disabil Rehabil. 2022 Nov;44(22):6668-6675. doi: 10.1080/09638288.2021.1970255. Epub 2021 Sep 2.