NCT02741934

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

April 13, 2016

Last Update Submit

October 13, 2017

Conditions

Very Low Birth Weight Infants

Outcome Measures

Primary Outcomes (1)

  • Cognitive function test

    8 Years old

Secondary Outcomes (8)

  • Brain MRI

    8 Years old

  • Korean Child Behavior Checklist

    8 Years old

  • Korean ADHD Rating Scale-IV

    8 Years old

  • Wechsler Scale of Intelligence-IV

    8 Years old

  • Advanced Test of Attention

    8 Years old

  • +3 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • children former preterm infants \< 32 weeks of gestation or 1,500gm of birth weight
  • children former normal term infants

You may not qualify if:

  • major congenital anomaly
  • neuromuscular disease
  • chromosomal anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 18, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 16, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)