NCT03172767

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

April 12, 2018

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 26, 2017

Last Update Submit

April 10, 2018

Conditions

Sensory DeficitPreterm Birth

Keywords

PretermSensory processingSchool 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 (1)

  • Sensory profile caregiver questionnaire

    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 Preschoolers and Term Preschoolers

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

Study Sites (1)

Gazı University

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bülent Elbasan

    study chair

    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
Principal Investigator

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 1, 2017

Study Start

March 20, 2017

Primary Completion

September 20, 2017

Study Completion

January 20, 2018

Last Updated

April 12, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

TU(1)