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

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: Metabolic Syndrome
• Intervention / Treatment: Other: Preterm/term cohort

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seung Han Shin
    • Contact: Seung Han Shin, MD; Phone Number: +82-2072-7230; Email: revival421@empas.com
    • Sub-Investigator: Young Hwa Jung, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	at 8 years corrected age

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 1509-030-702