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NCT00005105 Clinical Trial

Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation

Intrauterine Growth Retardation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00005105
Other study ID # 199/14924
Secondary ID CHMC-C-96-10-4
Status Recruiting
Phase N/A
First received April 6, 2000
Last updated June 23, 2005
Start date January 1997

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES:

I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.

Description:

PROTOCOL OUTLINE:

Patients undergo blood draw. Insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) are measured. Patients whose IGF-I and IGFBP-3 levels are average or above are tested for the presence of mutation in the insulin-like growth factor-I receptor.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Months to 18 Years
Eligibility - Intrauterine growth retardation (IUGR), defined as birth weight less than 2 standard deviations below the mean by Usher and McLean Deficient "catch-up" growth (stature less than 5th percentile on growth chart after age 18 months) Normal or elevated circulating concentrations of insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) IGF-I or IGFBP-3 within or above the 95th percentile confidence interval for age No other clinical explanation for poor prenatal and postnatal growth No IUGR due to maternal toxemia, endocrine disease, gastrointestinal disease, significant heart disease, or chromosomal abnormalities No other condition known to retard growth

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
United States Emory University School of Medicine Atlanta Georgia
United States Children's Hospital Medical Center - Cincinnati Cincinnati Ohio
United States James Whitcomb Riley Hospital for Children Indianapolis Indiana
United States Schneider Children's Hospital New Hyde Park New York
United States Medical College of Virginia School of Medicine Richmond Virginia

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

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