Prevalence and Clinical Spectrum of the 22q11 Deletion

Congenital Disorders Clinical Trial

Official title:

Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00267397
• Other study ID #: 01-107
• Status: Terminated
• Phase: N/A
• First received: December 19, 2005
• Last updated: May 2, 2007
• Start date: January 1967
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology.

Description:

Since 1967, The Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects in metropolitan Atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (Clayton, Cobb, DeKalk, Fulton and Gwinnett, and has been expanded to include prenatal records. The project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. The voluntary participation of Atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the CDC, the Georgia Institute of Mental Health and Emory University).

A case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination.

Children's Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• birth defect diagnosed by the child's sixth birthday

• birth defect diagnosed within 6 years of the elective date of termination

Exclusion Criteria:

• those who do not meet inclusion criteria

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Congenital Disorders

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States,