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Prevalence and Clinical Spectrum of the 22q11 Deletion

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Terminated
CT.gov ID
NCT00267397
Collaborator
(none)
1
Location
479
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Retrospective
    Official Title:
    Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects
    Study Start Date :
    Jan 1, 1967
    Study Completion Date :
    Dec 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 6 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Children's Healthcare of Atlanta Atlanta Georgia United States 30322

      Sponsors and Collaborators

      • Children's Healthcare of Atlanta

      Investigators

      • Principal Investigator: Robert M. Campbell, MD, Children's Healthcare of Atlanta

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00267397
      Other Study ID Numbers:
      • 01-107
      First Posted:
      Dec 21, 2005
      Last Update Posted:
      May 4, 2007
      Last Verified:
      May 1, 2007
      Keywords provided by , ,
      infant
      prenatal
      birth defects
      22Q11 deletion
      Additional relevant MeSH terms:
      DiGeorge Syndrome

      Study Results

      No Results Posted as of May 4, 2007