- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172767
The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler (Preterm)
April 10, 2018 updated by: Ayse Simsek, Gazi University
The study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness
Study Overview
Status
Completed
Conditions
Detailed Description
A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation.
Each group contains 30 children.
First, sociodemographic information and histories of children are obtaining.
Ages and contact information of the parents are recording.
Prenatal and natal risk factors of the mothers are querying.
Gestational ages and height, weight, and head circumferences of babies at birth are recording.
Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.
Marmara Primary School Readiness Scale is using to evaluate mental-language development, socio-emotional development, physical development, self-care skills,math skills, science skills, voice exercises, line exercises and labyrinths.
Sensory profile caregiver questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral and emotional responses. .
All examination wiil be finished in the same day.
Study Type
Observational
Enrollment (Actual)
60
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
-
-
-
Ankara, Turkey, 06560
- Gazı University
-
-
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
Ages Eligible for Study
5 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Preterm Preschoolers and Term Preschoolers
Description
Inclusion Criteria:
- No neurological diagnosis
- gestational age < 37 weeks
- 60-78 months of age
Exclusion Criteria:
- Have a neurological diagnosis (such as cerebral palsy)
- Grade III or grade IV intraventricular hemorrhage
- Have undergone major surgery in neonatal period
- Mental retardation
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 |
---|
Preterm Preschoolers
Preterm children who haven't attend school.
|
Term Preschoolers
Term children who haven't attend school.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Marmara Primary School Readiness Scale
Time Frame: 45 minutes
|
The application form includes math skills, science skills, voice exercises, line exercises and labyrinths; Development form; Mental-language development, socio-emotional development, physical development, self-care skills.
|
45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory profile caregiver questionnaire
Time Frame: 45 minutes
|
The profile reveals the child's sensory appearance in terms of sensory search, emotional response formation, low endurance, oral tenderness, distractibility, weak perception, sensory sensitivity, activity level and fine motor / perceptual differences.
In addition, the child evaluates the senses (sensory processing), adjustment (modulation), behavioral and emotional responses.
|
45 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 20, 2017
Primary Completion (Actual)
September 20, 2017
Study Completion (Actual)
January 20, 2018
Study Registration Dates
First Submitted
May 26, 2017
First Submitted That Met QC Criteria
May 31, 2017
First Posted (Actual)
June 1, 2017
Study Record Updates
Last Update Posted (Actual)
April 12, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.
Clinical Trials on Preterm Birth
-
e-Bio CorpRecruitingPreterm Labor | PreTerm Birth | Preterm Labor With Delivery NosUnited States
-
Thomas Jefferson UniversityCompleted
-
Chelsea and Westminster NHS Foundation TrustSPD Development Company Limited; Borne CharityRecruitingPreterm Birth | Preterm Labor | Preterm Birth Complication | Preterm Premature Rupture of Membrane | Preterm PregnancyUnited Kingdom
-
PreTeL, IncDuke University; University of RochesterRecruitingPreterm Birth | Threatened Preterm Labor | PreTerm LaborUnited States
-
Cairo UniversityCompleted
-
University of OklahomaCompletedPreTerm Birth | PreTerm NeonateUnited States
-
Federico II UniversityRecruiting
-
University of OxfordShoklo Malaria Research UnitCompleted
-
Eunice Kennedy Shriver National Institute of Child...CompletedPregnancy | Preterm Birth | Preterm LaborUnited States
-
University Hospital Inselspital, BerneAmniSure International LLCCompletedPreterm Birth | Preterm LabourSwitzerland