Cerebral PalsyPurple-NNCT03499288
Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition
An observational study of Cerebral Palsy, run by Nutricia Research at 20 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 499 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 11 Apr 2017to 3 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects between 1 month and 18 years of age with Cerebral Palsy
Who may be able to join
- 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
Who cannot join
- Neurodegenerative diseases
- Acute infections: meningitis, encephalitis or poliomyelitis
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
Turkey (Türkiye)9 sites
Ankara University School of Medicine/Neurology
Ankara
Gazi University School of Medicine/Neurology
Ankara
Hacettepe University School of Medicine/Neurology
Ankara
Ege University School of Medicine/Neurology
Ege
Eskisehir Osmangazi University School of Medicine/Neurology
Eskişehir
Inonu University School of Medicine/Neurology
İnönü
Dokuz Eylul University School of Medicine/Neurology
Izmir
Marmara University School of Medicine/Neurology
Marmara
Mersin University School of Medicine/Neurology
Mersin
Italy4 sites
AO Sant'Orsola - Malpighi, Policlinico
Bologna
ASST degli Spedali Civili di Brescia
Brescia
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milan
AOU di Modena - Policlinico
Modena
Poland2 sites
Medical university hospital of Gdansk
Gdansk
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
About this study
Official title: 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.
Read the 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.
- 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
- Cerebral Palsy
- Keywords
- Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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)
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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)
Measured: 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])
Measured: Data collected retrospectively, from within 12 months of entering the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start11 Apr 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499288
- Sponsor's protocol ID
- MPR15FA89628
- Acronym
- Purple-N
- Status last verified
- Nov 2018
- First submitted
- 21 Mar 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34473588
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03499288
- Acronym / sponsor ID
- Purple-N / MPR15FA89628
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects between 1 month and 18 years of age with Cerebral Palsy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Neurodegenerative diseases
- Acute infections: meningitis, encephalitis or poliomyelitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
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)
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]
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]
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]
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)
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])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Derived from this study: PubMed 34473588Fogarasi 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.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Nutricia Research at 20 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Turkey (Türkiye), Italy, Poland, Czechia, Greece and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify current CP characteristics 1 (general subject characteristics): (time frame: Data collected retrospectively, from within 12 months of entering the questionnaire). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.