Skip to content

Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00366821
Enrollment
1000
Registered
2006-08-21
Start date
2002-01-31
Completion date
2014-11-30
Last updated
2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Disorders

Keywords

cardiac, pediatric, genetic

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 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.

Interventions

None listed

Sponsors

Children's Healthcare of Atlanta
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.5 yearsWe wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026