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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03081624
Other study ID # E.5461
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 10, 2017
Last updated April 21, 2017
Start date December 17, 2016
Est. completion date July 17, 2018

Study information

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

Clinical Trial Summary

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.


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. The Touwen examination (neurological examination) is using to evaluate 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. All examination wiil be finished in the same day.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date July 17, 2018
Est. primary completion date July 17, 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
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

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
Secondary The Touwen examination (neurological examination) 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
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