Very Low Birth Weight InfantsNCT02741934
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
An observational study of Very Low Birth Weight Infants, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Infants
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 9 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- children former preterm infants < 32 weeks of gestation or 1,500gm of birth weight
- children former normal term infants
Who cannot join
- major congenital anomaly
- neuromuscular disease
- chromosomal anomaly
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Very Low Birth Weight Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function test
Measured: 8 Years old
Secondary outcomes (8)
Brain MRI
Measured: 8 Years old
Korean Child Behavior Checklist
Measured: 8 Years old
Korean ADHD Rating Scale-IV
Measured: 8 Years old
Wechsler Scale of Intelligence-IV
Measured: 8 Years old
Advanced Test of Attention
Measured: 8 Years old
Children's color trails test
Measured: 8 Years old
STROOP
Measured: 8 Years old
Wisconsin Card Sorting Test
Measured: 8 Years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KangWon National University Hospital
- Responsible party
- Principal investigator, Ee-Kyung Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741934
- Sponsor's protocol ID
- 2015-1927
- Status last verified
- Oct 2017
- First submitted
- 13 Apr 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
- ClinicalTrials.gov ID
- NCT02741934
- Acronym / sponsor ID
- 2015-1927
- Conditions
- Very Low Birth Weight Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- KangWon National University Hospital
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- children former preterm infants < 32 weeks of gestation or 1,500gm of birth weight
- children former normal term infants
Key exclusion criteria (3 listed)
- major congenital anomaly
- neuromuscular disease
- chromosomal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function test
Time frame: 8 Years old
8 secondary outcomes
Brain MRI
Time frame: 8 Years old
Korean Child Behavior Checklist
Time frame: 8 Years old
Korean ADHD Rating Scale-IV
Time frame: 8 Years old
Wechsler Scale of Intelligence-IV
Time frame: 8 Years old
Advanced Test of Attention
Time frame: 8 Years old
Children's color trails test
Time frame: 8 Years old
STROOP
Time frame: 8 Years old
Wisconsin Card Sorting Test
Time frame: 8 Years old
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Very Low Birth Weight Infants
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Active, not recruiting
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Very Low Birth Weight Infant
Enrolling by invitation
The Video System to Provide a Developmental Training Guide for Preterm Infants
Premature Infants, Very Low Birth Weight Infants
Recruiting
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
RecruitingObservational study
Swiss Neonatal Network & Follow-up Group
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight Infants, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function test (time frame: 8 Years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.