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Completed

NCT Number: NCT03499288

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fakultní nemocnice v Motole, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Quantify current CP characteristics 1 (general subject characteristics):

    Time frame: 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]

  2. Quantify current CP characteristics 2 (anthropometry):

    Time frame: 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)

  3. Quantify current CP characteristics 3 (motor function)

    Time frame: 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]

  4. Quantify current CP characteristics 4 (comorbidities)

    Time frame: 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]

  5. Quantify current CP characteristics 5 (therapies)

    Time frame: 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]

  6. Quantify current CP characteristics 6 (feeding mode)

    Time frame: 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)

  7. Quantify current CP characteristics 7 (nutritional status)

    Time frame: 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])

Other outcomes

  1. Quality of life and participation 1

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

    Questionnaire to assess Quality of Life of subjects with CP [scores on domains]

  2. Quality of life and participation 2

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

    Questionnaire to assess Quality of Life of parents (/legal representatives) of subjects with CP [scores on domains]

  3. Quality of life and participation 3

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

    Level of participation included in the general parent questionnaire [categories]

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study title

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

Acronym: Purple-N

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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