This trial is active, not recruiting.

Condition congenital disorders
Sponsor Children's Healthcare of Atlanta
Start date January 2002
Trial size 1000 participants
Trial identifier NCT00366821, 06-141


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective retrospective
Examine the outcomes following cardiac surgery in those newborns with genetic abnormalities.
Examine the outcomes following cardiac surgery in newborns without genetic abnormalities.

Eligibility Criteria

Male or female participants up to 30 days old.

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

Additional Information

Official title Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
Principal investigator Janet M Simsic, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Children's Healthcare of Atlanta.