Cognitive and Behavioral Outcomes of School-aged Children... | NCT02741934

Studies
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm

NCT02741934

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Oct 16, 2017Actual

Enrollment

111Actual

Phase

Not provided

Conditions

Very Low Birth Weight Infants

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 13, 2016

First Submission Date that Met QC Criteria

Apr 15, 2016

First Posted Date

Apr 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2017

Last Update Posted Date

Oct 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ee-Kyung Kim, Clinical associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
KangWon National University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.
Term control cohort		The infants who were born from 2008 to 2009 with term gestational age will be enrolled.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function test		8 Years old

Secondary Outcomes

Measure	Description	Time Frame
Brain MRI		8 Years old
Korean Child Behavior Checklist		8 Years old
Korean ADHD Rating Scale-IV

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

9 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided