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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02746887
• Other study ID #: 1509-030-702
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2015
• Last updated: April 18, 2016
• Start date: December 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: Seung Han Shin, MD
• Phone: +82-02-2072-7230
• Email: revival421[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 8 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Preterm/term cohort

Locations

Country	Name	City	State
Korea, Republic of	Seung Han Shin	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with abnormal laboratory values and/or abnormal physical status		at 8 years corrected age	No
Secondary	The number of participants with catch-up growth failure		at 8 years corrected age	No
Secondary	The number of participants with hypertension		at 8 years corrected age	No