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Neonates With Neurological Complications
This study is ongoing, but not recruiting participants.
Sponsored by: Children's Healthcare of Atlanta
Information provided by: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00366561
  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

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title: Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

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

Estimated Enrollment: 1000
Study Start Date: January 2002
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

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers: 06-139
Study First Received: August 17, 2006
Last Updated: August 17, 2006
ClinicalTrials.gov Identifier: NCT00366561  
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on January 16, 2009