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Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00366821
First received: August 17, 2006
Last updated: March 14, 2012
Last verified: November 2007
History of Changes

August 17, 2006
March 14, 2012
January 2002
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Complete list of historical versions of study NCT00366821 on ClinicalTrials.gov Archive Site
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Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

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.

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.
Observational
Time Perspective: Retrospective
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Non-Probability Sample

Patients' charts will be reviewed from Children's Healtcare of Atlanta between January 1, 2002 through December 31, 2006 of all neonates who underwent cardiac surgery.
Congenital Disorders
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  • 1
    Examine the outcomes following cardiac surgery in those newborns with genetic abnormalities.
  • 2
    Examine the outcomes following cardiac surgery in newborns without genetic abnormalities.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
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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
Both
up to 30 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00366821
06-141
No
Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
Not Provided
Principal Investigator: Janet M Simsic, MD Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP