NCT02589704

Brief Summary

This is a single visit, non-interventional, cross sectional study about risk factors, etiology, nutritional status and feeding methods in CP patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,123

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

October 19, 2015

Last Update Submit

July 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of malnutrition

    physician assessment

    at enrollment

Secondary Outcomes (2)

  • etiology of CP

    at enrollment

  • correlation between type of CP and nutritional status

    at enrollment

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Adana Numune Training and Research Hospital

Adana, Turkey (Türkiye)

Location

Ankara Child Health and Diseases, Hematology, Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Gulhane Military Medical Academy

Ankara, Turkey (Türkiye)

Location

Sami Ulus Maternity and Child Health and Diseases Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Fırat University Medical Faculty

Elâzığ, Turkey (Türkiye)

Location

Osmangazi University Medical Faculty

Eskişehir, Turkey (Türkiye)

Location

Marmara Universty Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Zeynep Kamil Woman and Child Diseases Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Dr. Behçet Uz Children's Hospital

Izmir, Turkey (Türkiye)

Location

İzmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmam University Medical Faculty

Kahramanmaraş, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Kayseri, Turkey (Türkiye)

Location

Selçuk University Medical Faculty

Konya, Turkey (Türkiye)

Location

İnönü Universty Medical Faculty

Malatya, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Location

Harran University Medical Faculty

Sanliurfa, Turkey (Türkiye)

Location

Karadeniz Technical University Medical Faculty

Trabzon, Turkey (Türkiye)

Location

Study Officials

  • Aysugul Alptekin, MD

    Abbott Nutrition Turkey

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 28, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations