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Neonates With Neurological Complications

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Completed
CT.gov ID
NCT00366561
Collaborator
(none)
810
Enrollment
1
Location
99
Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this retrospective study is to identify all neonates (newborns < 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Studies have shown that between one-quarter and one-half of infants undergoing cardiac surgery will suffer brain injury during surgery (the perioperative period). Some infants with congenital heart disease have neurological injury prior to cardiac surgery as a result of cyanosis, acidosis and abnormal circulation. The spectrum of neurological injury ranges from agitation and subtle disturbances in learning and new memory acquisition to visual and motor development abnormalities, seizures, stroke and encephalopathy.

    The patient will be identified from the cardiothoracic surgery database. Their hospital medical records and the neurological database will be reviewed for type of neurological complication (i.e. seizure, stroke), neuro-imaging and any mortality for these patients. We will review the patient outcome data that is available, after the initial surgery, through June 20, 2006. No patients will be contacted.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    810 participants
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery
    Study Start Date :
    Jan 1, 2002
    Actual Primary Completion Date :
    Apr 1, 2010
    Actual Study Completion Date :
    Apr 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates. [6 years]

      In congenital cardiac defects where there was a choice of palliation vs complete anatomic repair, premature neonates underwent palliative procedures more frequently than term neonates. Premature neonates spent more days of mechanical ventilation compared to their term counterparts. Importantly, there was no difference in mortality between the two groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 30 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children's Healthcare of Atlanta patients

    • January 1, 2002 through June 20, 2006

    • < 30 days of age

    • neurological complications following cardiac surgery

    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, Sibley Heart Center Cardiology at 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:
    NCT00366561
    Other Study ID Numbers:
    • 06-139
    First Posted:
    Aug 21, 2006
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Children's Healthcare of Atlanta
    neonates
    neurological complications
    surgery

    Study Results

    No Results Posted as of Dec 2, 2014