Nutritional StatusNCT02589704
Nutritional Status of Cerebral Palsy Patients in Turkey
An observational study of Nutritional Status, run by Abbott Nutrition at 18 sites in Turkey (Türkiye).
Trial summary
This is a single visit, non-interventional, cross sectional study about risk factors, etiology, nutritional status and feeding methods in CP patients. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Nutritional Status
- How many people
- 1,123 participants
- Where
- 18 sitesTurkey (Türkiye)
- Study dates
- Nov 2015to Apr 2016
- 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 year to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of patients at pediatric neurology outpatient clinic diagnosed with CP, 12 months to less than 19 years old.
Who may be able to join
- Subject is greater than/equal to 12 months and less than 19 years of age.
- Subject is diagnosed with cerebral palsy (CP) by a physician.
Who cannot join
- Subject presents with genopathies, cardiopathies, hypothyroidism or any pathology not related to CP.
- Subject is diagnosed with CP of postnatal origin.
- Subject has other concomitant diagnoses.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Turkey (Türkiye)18 sites
Adana Numune Training and Research Hospital
Adana
Ankara Child Health and Diseases, Hematology, Oncology Training and Research Hospital
Ankara
Gazi University Medical Faculty
Ankara
Gulhane Military Medical Academy
Ankara
Sami Ulus Maternity and Child Health and Diseases Training and Research Hospital
Ankara
Fırat University Medical Faculty
Elâzığ
Osmangazi University Medical Faculty
Eskişehir
Marmara Universty Pendik Training and Research Hospital
Istanbul
Zeynep Kamil Woman and Child Diseases Training and Research Hospital
Istanbul
Dr. Behçet Uz Children's Hospital
Izmir
İzmir Tepecik Training and Research Hospital
Izmir
Kahramanmaraş Sütçü İmam University Medical Faculty
Kahramanmaraş
Erciyes University Medical Faculty
Kayseri
Selçuk University Medical Faculty
Konya
İnönü Universty Medical Faculty
Malatya
Mersin University Medical Faculty
Mersin
Harran University Medical Faculty
Sanliurfa
Karadeniz Technical University Medical Faculty
Trabzon
About this study
Official title: A Prospective, Cross Sectional Study to Evaluate the Etiology and Nutritional Status of Cerebral Palsy Patients in Turkey
This is a single visit, non-interventional, cross sectional study about risk factors, etiology, nutritional status and feeding methods in CP patients.
- Conditions
- Nutritional Status
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of malnutrition
physician assessment
Measured: at enrollment
Secondary outcomes (2)
etiology of CP
physician assessment/medical record
Measured: at enrollment
correlation between type of CP and nutritional status
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aysugul Alptekin, MD, Study chair, Abbott Nutrition Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589704
- Sponsor's protocol ID
- DA10
- Status last verified
- Jul 2016
- First submitted
- 19 Oct 2015
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Cross Sectional Study to Evaluate the Etiology and Nutritional Status of Cerebral Palsy Patients in Turkey
- ClinicalTrials.gov ID
- NCT02589704
- Acronym / sponsor ID
- DA10
- Conditions
- Nutritional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,123 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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.
This is a single visit, non-interventional, cross sectional study about risk factors, etiology, nutritional status and feeding methods in CP patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of patients at pediatric neurology outpatient clinic diagnosed with CP, 12 months to less than 19 years old.
Key inclusion criteria (2 listed)
- Subject is greater than/equal to 12 months and less than 19 years of age.
- Subject is diagnosed with cerebral palsy (CP) by a physician.
Key exclusion criteria (3 listed)
- Subject presents with genopathies, cardiopathies, hypothyroidism or any pathology not related to CP.
- Subject is diagnosed with CP of postnatal origin.
- Subject has other concomitant diagnoses.
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
prevalence of malnutrition
Time frame: at enrollment
physician assessment
2 secondary outcomes
etiology of CP
Time frame: at enrollment
correlation between type of CP and nutritional status
Time frame: at enrollment
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 1 Aug 2016.
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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.
Aysugul Alptekin, MD study chair
Abbott Nutrition Turkey
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status, run by Abbott Nutrition at 18 sites in Turkey (Türkiye).
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 2 inclusion and 3 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Turkey (Türkiye). 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?
prevalence of malnutrition (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2016.