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



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

For Condition: Intrauterine Growth Retardation
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Children's Hospital Medical Center - Cincinnati
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Observational, Screening
Minimum Age/Maximum Age: 18 Months/18 Years
Genders: Both
Protocol Entry Criteria: - 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
Total Enrollment: 75

Location and Contact Information:

Overall Study Official:
StevenChernausek,  Study Chair,  Children's Hospital Medical Center - Cincinnati

Schneider Children's Hospital *Recruiting*
New Hyde Park,  New York,  11042
United States
Recruiting Graeme  Frank 718-470-3390

Children's Hospital Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45229-3039
United States
Recruiting Steven  Chernausek 513-636-4744

Emory University School of Medicine *Terminated*
Atlanta,  Georgia,  30322
United States
Terminated  

James Whitcomb Riley Hospital for Children *Recruiting*
Indianapolis,  Indiana,  46202-5225
United States
Recruiting Ora  Pescovitz 317-274-3889

Medical College of Virginia School of Medicine *Recruiting*
Richmond,  Virginia,  23298-0230
United States
Recruiting Paul  Kaplowitz 804-786-9788


Additional Information:
Study ID Numbers:
  199/14924;  CHMC-C-96-10-4
Study Start Date: January 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005105

Other Intrauterine Growth Retardation Studies:
1. Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation

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