This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Insulin-like growth factor I (IGF-I) is produced in response to pituitary growth hormone (GH) and is a major regulator of growth. Some children have IGF-I deficiency because they cannot respond to their own GH. They have severe growth retardation unresponsive to conventional therapies. This study evaluates the safety and efficacy of recombinant human IGF-I (rhIGF-I) given to short children with growth hormone insensitivity. Children must have clinically documented GH insensitivity with serum IGF-I levels that are low for age, normal GH secretion and evidence for failure of GH action, or have developed GH-neutralizing antibodies during GH treatment. Once enrolled, children are treated with subcutaneous injection of rhIGF-I twice daily until they reach final height. The primary efficacy endpoint is growth rate. Subjects are evaluated a minimum of every 6 months. Safety measures include monitoring of blood chemistries, kidney and spleen growth, and cardiac function.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR008084-13
Application #
7374484
Study Section
Special Emphasis Panel (ZRR1-CR-9 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
13
Fiscal Year
2006
Total Cost
$10,633
Indirect Cost
Name
Children's Hospital Med Ctr (Cincinnati)
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
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