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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02746887
• Collaborator: (none)
• Enrollment: 120
• Location: 1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Preterm/term cohort

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Risk Factors Related to Metabolic Syndrome in School-aged Children Who Were Born Preterm
• Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Nov 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. number of participants with abnormal laboratory values and/or abnormal physical status [at 8 years corrected age]

Secondary Outcome Measures

1. The number of participants with catch-up growth failure [at 8 years corrected age]

2. The number of participants with hypertension [at 8 years corrected age]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seung Han Shin	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung Han Shin, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02746887
• Other Study ID Numbers: 1509-030-702
• First Posted: Apr 21, 2016
• Last Update Posted: Apr 21, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Apr 21, 2016