- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741934
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
October 13, 2017 updated by: Ee-Kyung Kim, Seoul National University Hospital
This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.
Study Overview
Status
Completed
Conditions
Detailed Description
There are lots of studies published that school-aged children who were born preterm has some behavioral problems in school and they also have poor academical achievement.
Study Type
Observational
Enrollment (Actual)
111
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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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
8 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Among the infants who were born and admitted to Seoul National University Hospital from 2008 to 2009, the birth weight of the infants less than 1,500g or gestational age less than 32 weeks patients were enrolled.
The infants who were born from 2008 to 2009 with term gestational age will also be enrolled.
Description
Inclusion Criteria:
- children former preterm infants < 32 weeks of gestation or 1,500gm of birth weight
- children former normal term infants
Exclusion Criteria:
- major congenital anomaly
- neuromuscular disease
- chromosomal anomaly
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 |
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Preterm cohort
Among the infants who were born and admitted to Seoul National University Hospital from 2008 to 2009, the birth weight of the infants less than 1,500g or gestational age less than 32 weeks patients were enrolled.
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Term control cohort
The infants who were born from 2008 to 2009 with term gestational age will be enrolled.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Cognitive function test
Time Frame: 8 Years old
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8 Years old
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Brain MRI
Time Frame: 8 Years old
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8 Years old
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Korean Child Behavior Checklist
Time Frame: 8 Years old
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8 Years old
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Korean ADHD Rating Scale-IV
Time Frame: 8 Years old
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8 Years old
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Wechsler Scale of Intelligence-IV
Time Frame: 8 Years old
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8 Years old
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Advanced Test of Attention
Time Frame: 8 Years old
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8 Years old
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Children's color trails test
Time Frame: 8 Years old
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8 Years old
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STROOP
Time Frame: 8 Years old
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8 Years old
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Wisconsin Card Sorting Test
Time Frame: 8 Years old
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8 Years old
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
October 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
April 15, 2016
First Posted (Estimate)
April 18, 2016
Study Record Updates
Last Update Posted (Actual)
October 16, 2017
Last Update Submitted That Met QC Criteria
October 13, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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