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Sponsored by: |
Children's Healthcare of Atlanta |
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Information provided by: | Children's Healthcare of Atlanta |
ClinicalTrials.gov Identifier: | NCT00366561 |
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 |
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Congenital Disorders |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Retrospective Study |
Official Title: | Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2002 |
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.
Ages Eligible for Study: | up to 30 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Children's Healthcare of Atlanta | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Janet M Simsic, MD | Sibley Heart Center Cardiology at Children's Healthcare of Atlanta |
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 |
neonates neurological complications surgery |