NCT03081624

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
Last Updated

April 25, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

March 10, 2017

Last Update Submit

April 21, 2017

Conditions

School Readiness

Keywords

pretermneurological statusSchool Readiness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sensory profile caregiver questionnaire

    45 minutes

  • The Touwen examination (neurological examination)

    45 minutes

Study Arms (2)

Preterm Preschoolers

Preterm children who haven't attend school.

Term Preschoolers

Term children who haven't attend school.

Eligibility Criteria

Age60 Months - 78 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm children and their age -matched term volunteers

You may qualify if:

  • No neurological diagnosis
  • gestational age \< 37 weeks
  • months of age

You may not qualify if:

  • Have a neurological diagnosis (such as cerebral palsy)
  • Grade III or grade IV intraventricular hemorrhage
  • Have undergone major surgery in neonatal period
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Bülent Elbasan, Phd

    Gazi University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

December 17, 2016

Primary Completion

July 17, 2017

Study Completion

July 17, 2018

Last Updated

April 25, 2017

Record last verified: 2017-03