Determining the Long-Term Effects of Prenatal Dexamethasone Treatment in Children With 21-Hydroxylase Deficiency and Their Mothers
Status unconfirmed
Conditions studied: Adrenal Hyperplasia, Congenital
In brief
Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency (21OHD), which leads to cortisol deficiency and causes the development of mature masculine characteristics in newborn, prepubescent, and grown females, and prepubescent males. Prenatal treatment with dexamethasone, a corticosteroid, has been shown to reduce the masculinization of genitalia. However, the long-term effects of dexamethasone on the children who received it as fetuses and on mothers who were exposed to it while they were pregnant have not been determined. This study will investigate potential long-term adverse side effects of prenatal dexamethasone treatment in children and young adults who received dexamethasone as fetuses and their mothers who were exposed to it during pregnancy.
Key facts
- Study ID
- NCT00617292
- Run by
- Office of Rare Diseases (ORD)
- People needed
- 233
- Starts
- 2008-01-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2008-12-09
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For all participants:
- English-speaking
- Has undergone DNA testing for mutations in the CYP21A2 gene
- For children who received prenatal dexamethasone treatment:
- Genetic confirmation of 21OHD diagnosis
- Received full or partial prenatal dexamethasone treatment
- For children in the control group:
- Did not receive prenatal dexamethasone treatment
- For mothers:
- History of at-risk pregnancy for a fetus affected with 21OHD
- Genetic confirmation of child's diagnosis
You may not qualify if…
- Any mental disorder that could prevent understanding of study materials
- Current or past steroid use for reasons other than CAH (i.e., asthma, lupus, rheumatoid arthritis)
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States (enrolling)
- University of Lyon — Lyon, France (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- University of Sao Paolo — São Paulo, São Paulo, Brazil
Full record on ClinicalTrials.gov
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