Viewing Study NCT00267397



Ignite Creation Date: 2024-05-05 @ 12:09 PM
Last Modification Date: 2024-10-26 @ 9:21 AM
Study NCT ID: NCT00267397
Status: TERMINATED
Last Update Posted: 2007-05-04
First Post: 2005-12-19

Brief Title: Prevalence and Clinical Spectrum of the 22q11 Deletion
Sponsor: Childrens Healthcare of Atlanta
Organization: Childrens Healthcare of Atlanta

Study Overview

Official Title: Prevalence and Clincial Spectrum of the 22q11 Deletion A Population Based Study of Children and Congenital Heart Defects
Status: TERMINATED
Status Verified Date: 2007-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: sufficient data collected
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 childs sixth birthday or within six years of the date of elective termination

Childrens Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None