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Neonates With Neurological Complications

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00366561
First Posted: August 21, 2006
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
  Purpose
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
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates. [ Time Frame: 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.


Enrollment: 810
Study Start Date: January 2002
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366561


Locations
United States, Georgia
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
  More Information

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00366561     History of Changes
Other Study ID Numbers: 06-139
First Submitted: August 17, 2006
First Posted: August 21, 2006
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Children's Healthcare of Atlanta:
neonates
neurological complications
surgery