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OpenTrials
Completed

NCT Number: NCT00366821

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.

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Key information

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Registry information

Important dates

Study start
2002
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2006
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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