- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03081624
Evaluation of Neurological Status and School Readiness in Preterm Preschoolers
Evaluation of Neurological Status and School Readiness of Preterm Children in Preschool Period
Beginning school is an important milestone for children. Children's readiness for school involves cognitive, physical, and emotional development. While the majority of children born preterm are able to transition from preschool to kindergarten with little difficulty, some children experience challenges during this time. Factors that negatively influence children's success in kindergarten include their age, socioeconomic status, neurological status and their ability to interpret sensory information from their environment.
This study was planned to explain the relationship between the primary school readiness and the neurological status of preterm born children.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
The Touwen examination (neurological examination)
Time Frame: 45 minutes
|
The assesment includes traditional neurological items, such as the evaluation of posture in various positions, muscle tone, dyskinesias, range of motion, reflexes, sensory function and cranial nerve function as well as developmental items, i.e. the items dealing with coordination, fine manipulative abilities and associated movements.
|
45 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.5461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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