Status:

UNKNOWN

Determining the Long-Term Effects of Prenatal Dexamethasone Treatment in Children With 21-Hydroxylase Deficiency and Their Mothers

Lead Sponsor:

Office of Rare Diseases (ORD)

Conditions:

Adrenal Hyperplasia, Congenital

Eligibility:

All Genders

12+ years

Brief Summary

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 cor...

Detailed Description

CAH is a genetic steroidogenesis disorder. The most common form, 21OHD, leads to cortisol deficiency and, in turn, an excess of androgen, a hormone that promotes the development and maintenance of mal...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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)

Key Trial Info

Start Date :

January 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2009

Estimated Enrollment :

233 Patients enrolled

Trial Details

Trial ID

NCT00617292

Start Date

January 1 2008

End Date

July 1 2009

Last Update

December 9 2008

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Mount Sinai School of Medicine

New York, New York, United States, 10029

2

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

3

University of Sao Paolo

São Paulo, São Paulo, Brazil

4

University of Lyon

Lyon, France