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

NCT ID: NCT03499288

Last Updated: 2018-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

499 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-11

Study Completion Date

2018-07-03

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fakultní nemocnice v Motole

Prague, , Czechia

Site Status

Attikon University General Hospital

Athens, , Greece

Site Status

Bethesda Children Hospital Budapest

Budapest, , Hungary

Site Status

AO Sant'Orsola - Malpighi, Policlinico

Bologna, , Italy

Site Status

ASST degli Spedali Civili di Brescia

Brescia, , Italy

Site Status

Fondazione IRCCS Istituto Neurologico "Carlo Besta"

Milan, , Italy

Site Status

AOU di Modena - Policlinico

Modena, , Italy

Site Status

Roessingh centrum voor Revalidatie

Enschede, , Netherlands

Site Status

Medical university hospital of Gdansk

Gdansk, , Poland

Site Status

Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

Site Status

Fakultná nemocnica Trnava

Trnava, , Slovakia

Site Status

Ankara University School of Medicine/Neurology

Ankara, , Turkey (Türkiye)

Site Status

Gazi University School of Medicine/Neurology

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe University School of Medicine/Neurology

Ankara, , Turkey (Türkiye)

Site Status

Ege University School of Medicine/Neurology

Ege, , Turkey (Türkiye)

Site Status

Eskisehir Osmangazi University School of Medicine/Neurology

Eskişehir, , Turkey (Türkiye)

Site Status

Dokuz Eylul University School of Medicine/Neurology

Izmir, , Turkey (Türkiye)

Site Status

Inonu University School of Medicine/Neurology

İnönü, , Turkey (Türkiye)

Site Status

Marmara University School of Medicine/Neurology

Marmara, , Turkey (Türkiye)

Site Status

Mersin University School of Medicine/Neurology

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Czechia Greece Hungary Italy Netherlands Poland Slovakia Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34473588 (View on PubMed)

Other Identifiers

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MPR15FA89628

Identifier Type: -

Identifier Source: org_study_id

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