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.

Condition
Intrauterine Growth Retardation

Further Study Details: 

Expected Total Enrollment:  75

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.

Ages Eligible for Study:  18 Months   -   18 Years,  Genders Eligible for Study:  Both

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

Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Terminated
Indiana
      James Whitcomb Riley Hospital for Children, Indianapolis,  Indiana,  46202-5225,  United States; Recruiting
New York
      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States; Recruiting
Ohio
      Children's Hospital Medical Center - Cincinnati, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
Virginia
      Medical College of Virginia School of Medicine, Richmond,  Virginia,  23298-0230,  United States; Recruiting

Study chairs or principal investigators

Steven D. Chernausek,  Study Chair,  Children's Hospital Medical Center - Cincinnati   

Study ID Numbers:  199/14924; CHMC-C-96-10-4
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005105
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08