Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366821
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2006-08-17
Brief Title:
Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 geneticchromosomal 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 Childrens 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
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 Childrens 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
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