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Clinical Trials/NCT00366821
NCT00366821
Completed
Not Applicable

Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Children's Healthcare of Atlanta1 site in 1 country1,000 target enrollmentJanuary 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Disorders
Sponsor
Children's Healthcare of Atlanta
Enrollment
1000
Locations
1
Primary Endpoint
We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Our hope is that the information from this retrospective study will provide information to better serve our patients and their parents with risk stratification (levels of risk) and clinical expectations of patients after cardiac surgery who have genetic abnormalities and those who do not have genetic abnormalities.

Detailed Description

Screening for genetic/chromosomal abnormalities has become more frequent both pre-natally and post-natally. Therefore, we plan to review the outcomes in newborns with genetic abnormalities after cardiac surgery compared to those newborns without genetic abnormalities after cardiac surgery. We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities. We will compare morality rates and co-morbidities in each group. We will retrospectively review the cardiac surgical database and patient medical records for all neonates (newborns \< 30 days of age) who underwent cardiac surgery from January 1, 2002 through May 31, 2006 at Children's Healthcare of Atlanta. We plan to collect data on approximately 1000 patients including date of birth, age, weight, gestation, prenatal diagnosis, genetic abnormality, cardiac defect, surgery, operative details, pre-op and post-op complications, length of time on ventilator, hospital stay and mortality for these patients. We will review the patient outcome data available after their initial surgery through May 31, 2006. No patients will be contacted.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
November 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • neonates (newborns\< 30 days of age)
  • cardiac surgery between 1/1/02 - 5/31/06
  • at Children's Healthcare of Atlanta

Exclusion Criteria

  • those who do not meet inclusion criteria

Outcomes

Primary Outcomes

We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.

Time Frame: 5 years

We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.

Study Sites (1)

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