Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition (Purple-N)

November 15, 2018 updated by: Nutricia Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
499

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia
        • Fakultni nemocnice v Motole
  • Greece
      • Athens, Greece
        • Attikon University General Hospital
  • Hungary
      • Budapest, Hungary
        • Bethesda Children Hospital Budapest
  • Italy
      • Bologna, Italy
        • AO Sant'Orsola - Malpighi, Policlinico
      • Brescia, Italy
        • ASST Degli Spedali Civili di Brescia
      • Milano, Italy
        • Fondazione IRCCS Istituto Neurologico "Carlo Besta"
      • Modena, Italy
        • AOU di Modena - Policlinico
  • Netherlands
      • Enschede, Netherlands
        • Roessingh centrum voor Revalidatie
  • Poland
      • Gdańsk, Poland
        • Medical university hospital of Gdansk
      • Poznań, Poland
        • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Slovakia
      • Trnava, Slovakia
        • Fakultna nemocnica Trnava
  • Turkey
      • Ankara, Turkey
        • Ankara University School of Medicine/Neurology
      • Ankara, Turkey
        • Gazi University School of Medicine/Neurology
      • Ankara, Turkey
        • Hacettepe University School of Medicine/Neurology
      • Ege, Turkey
        • Ege University School of Medicine/Neurology
      • Eskişehir, Turkey
        • Eskisehir Osmangazi University School of Medicine/Neurology
      • Marmara, Turkey
        • Marmara University School of Medicine/Neurology
      • Mersin, Turkey
        • Mersin University School of Medicine/Neurology
      • İnönü, Turkey
        • Inonu University School of Medicine/Neurology
      • İzmir, Turkey
        • Dokuz Eylul University School of Medicine/Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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]
Data collected retrospectively, from within 12 months of entering the questionnaire
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)
Data collected retrospectively, from within 12 months of entering the questionnaire
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]
Data collected retrospectively, from within 12 months of entering the questionnaire
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]
Data collected retrospectively, from within 12 months of entering the questionnaire
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]
Data collected retrospectively, from within 12 months of entering the questionnaire
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)
Data collected retrospectively, from within 12 months of entering the questionnaire
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])
Data collected retrospectively, from within 12 months of entering the questionnaire

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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]
Data collected retrospectively, from within 12 months of entering the questionnaire
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]
Data collected retrospectively, from within 12 months of entering the questionnaire
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]
Data collected retrospectively, from within 12 months of entering the questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MPR15FA89628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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