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.

Study Overview

• Status: Completed
• Conditions: Congenital Disorders

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Janet M Simsic, MD, Children's Healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 17, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: pediatric; genetic; cardiac
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 06-141