Neonates With Neurological Complications
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|ClinicalTrials.gov Identifier: NCT00366561|
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : December 2, 2014
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||810 participants|
|Official Title:||Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
- 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.
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
|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|