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Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Completed
CT.gov ID
NCT00366821
Collaborator
(none)
1,000
Enrollment
1
Location
154
Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Review of the Outcomes of Newborns With Genetic Abnormalities
    Study Start Date :
    Jan 1, 2002
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities. [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 30 Days
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Healthcare of Atlanta Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Children's Healthcare of Atlanta

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Healthcare of Atlanta
    ClinicalTrials.gov Identifier:
    NCT00366821
    Other Study ID Numbers:
    • 06-141
    First Posted:
    Aug 21, 2006
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Children's Healthcare of Atlanta
    cardiac
    pediatric
    genetic
    Additional relevant MeSH terms:
    Congenital Abnormalities

    Study Results

    No Results Posted as of Dec 2, 2014