Risk Factors Related to Metabolic Syndrome in School-aged Children Who Were Born Preterm

April 18, 2016 updated by: Seung Han Shin, Seoul National University Hospital

This is a follow-up cohort study of 8 years old children born preterm at Seoul National University Children's Hospital in Korea from 2008-2009.

The children will visit outpatient clinics for examinations regarding growth, obesity and other risk factors related to metabolic syndrome.

The purpose of this study is to compare growth and risk factors of metabolic syndrome among children born preterm and children born healthy term at school age

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seung Han Shin
        • Contact:
        • Sub-Investigator:
          • Young Hwa Jung, MD

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 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. school aged children who were born preterm with a gestational age less than 32 weeks or a birth weight less than 1,500 g
  2. school aged children who were born healthy term

Description

Inclusion Criteria:

  • Very low birth weight infants and/or born less than 32 weeks of gestation age
  • Healthy term infants for control group
  • Parents and children accept of participation

Exclusion Criteria:

  • Major congenital anomalies
  • Neuromuscular disease
  • Chromosomal anomalies
  • Patients receiving growth hormone therapy
  • Primary hypothyroidism

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
Intervention / Treatment
Preterm cohort
Preterm infants with a gestational age less than 32 weeks or birth weight less than 1,500 g
Other: Preterm/term cohort
Term control cohort
Healthy term infants
Other: Preterm/term cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of participants with abnormal laboratory values and/or abnormal physical status
Time Frame: at 8 years corrected age
at 8 years corrected age

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of participants with catch-up growth failure
Time Frame: at 8 years corrected age
at 8 years corrected age
The number of participants with hypertension
Time Frame: at 8 years corrected age
at 8 years corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Seung Han Y Shin, MD, Seoul National University Children's Hospital

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

December 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1509-030-702

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.

Clinical Trials on Metabolic Syndrome

Clinical Trials on Preterm/term cohort

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe