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

NCT03499288 | Completed

• 1 other identifier: MPR15FA89628
• Study Type: observational
• Target: 499
• Locations: 8 countries
• Sites: 20

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Other Outcomes (3)

• Quality of life and participation 1

  Data collected retrospectively, from within 12 months of entering the questionnaire

• Quality of life and participation 2

  Data collected retrospectively, from within 12 months of entering the questionnaire

• Quality of life and participation 3

  Data collected retrospectively, from within 12 months of entering the questionnaire

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects between 1 month and 18 years of age with Cerebral Palsy

You may qualify if:

• Confirmed diagnosis of Cerebral Palsy
• Age\<18 years
• Have visited the HCP within the last year
• Written informed consent provided by parents/legal representatives according to local law

You may not qualify if:

• Neurodegenerative diseases
• Acute infections: meningitis, encephalitis or poliomyelitis

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (20)

Fakultní nemocnice v Motole

Prague, Czechia

Location

Attikon University General Hospital

Athens, Greece

Location

Bethesda Children Hospital Budapest

Budapest, Hungary

Location

AO Sant'Orsola - Malpighi, Policlinico

Bologna, Italy

Location

ASST degli Spedali Civili di Brescia

Brescia, Italy

Location

Fondazione IRCCS Istituto Neurologico "Carlo Besta"

Milan, Italy

Location

AOU di Modena - Policlinico

Modena, Italy

Location

Roessingh centrum voor Revalidatie

Enschede, Netherlands

Location

Medical university hospital of Gdansk

Gdansk, Poland

Location

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

Poznan, Poland

Location

Fakultná nemocnica Trnava

Trnava, Slovakia

Location

Ankara University School of Medicine/Neurology

Ankara, Turkey (Türkiye)

Location

Gazi University School of Medicine/Neurology

Ankara, Turkey (Türkiye)

Location

Hacettepe University School of Medicine/Neurology

Ankara, Turkey (Türkiye)

Location

Ege University School of Medicine/Neurology

Ege, Turkey (Türkiye)

Location

Eskisehir Osmangazi University School of Medicine/Neurology

Eskişehir, Turkey (Türkiye)

Location

Dokuz Eylul University School of Medicine/Neurology

Izmir, Turkey (Türkiye)

Location

Inonu University School of Medicine/Neurology

İnönü, Turkey (Türkiye)

Location

Marmara University School of Medicine/Neurology

Marmara, Turkey (Türkiye)

Location

Mersin University School of Medicine/Neurology

Mersin, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34473588 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 17, 2018
• Study Start: April 11, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); GR (1); IT (4); NL (1); HU (1); TU (9); SL (1); PL (2)