Evaluation of Neurological Status and School Readiness in Preterm Preschoolers

April 21, 2017 updated by: Ramazan Yildiz, Gazi University

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

Unknown

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. 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.

Study Type

Observational

Enrollment (Anticipated)

60

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 children and their age -matched term volunteers

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
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

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)

December 17, 2016

Primary Completion (Anticipated)

July 17, 2017

Study Completion (Anticipated)

July 17, 2018

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Haven't decided yet.

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.

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