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NCT00366821 Clinical Trial

Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Congenital Disorders Clinical Trial

Official title:
Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00366821
Other study ID # 06-141
Secondary ID
Status Completed
Phase N/A
First received August 17, 2006
Last updated November 26, 2014
Start date January 2002
Est. completion date November 2014

Study information
Verified date November 2014
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Days
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities. We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities. 5 years No
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