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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03172767
Other study ID # 5461
Secondary ID
Status Completed
Phase
First received May 26, 2017
Last updated April 10, 2018
Start date March 20, 2017
Est. completion date January 20, 2018

Study information

Verified date May 2017
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 20, 2018
Est. primary completion date September 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Months to 78 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Marmara Primary School Readiness Scale 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 Sensory profile caregiver questionnaire 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
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