Critical Congenital Heart Defect (CHD) Outcomes in Children

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Martha L. Clabby, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00208689
First received: September 13, 2005
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

Congenital heart disease in infants and children often challenges healthcare providers both in regards to diagnosis and in the management of these conditions. The field becomes more complicated as one examines the myriad of defects that present and the complex care that is required. Over the last 20-25 years, the remarkable advances in the medical and surgical management of the most complex lesions have decreased neonatal mortality, such that many more survive the neonatal period. Therefore, new challenges regarding the continued care of this patient cohort of high-risk infants and children exist. In order to continue the improvement of treatment(s) offered to these patients, continuous review and analysis of the current standard of care is needed.

In this study, the investigators will collect information related to the current surgical and medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at Children's Healthcare of Atlanta. All of the procedure and visit information will be a part of the child's standard of care. This information will be placed in a database. The investigators hope to learn more about the short-term and long-term effects of current therapies and procedures.


Condition
Congenital Heart Disease

Study Type: Observational
Official Title: A Review of the Diagnosis, Treatment and Outcomes of Children With Critical Congenital Heart Defects

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 150
Study Start Date: January 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Critical congenital heart disease
  • Signed informed consent

Exclusion Criteria:

  • Not diagnosed with critical congenital heart disease
  • No signed informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208689

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Martha Clabby, MD Emory University and Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Martha L. Clabby, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208689     History of Changes
Other Study ID Numbers: 1058-2003
Study First Received: September 13, 2005
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatric
congenital heart disease

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2014