An observational study in Congenital Disorders, sponsored by Children's Healthcare of Atlanta. Completed at 1 site in United States. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by Children's Healthcare of Atlanta · Observational
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
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.
25 studies on the registry are indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 14 are open to participants now.
This study's enrollment of 810 is above the median of 705 across 10 observational studies indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities.
Browse Congenital, Hereditary, and Neonatal Diseases and Abnormalities studies →Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.
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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.
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Exclusion Criteria:
The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.
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.
Time frame: 6 years
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Congenital, Hereditary, and Neonatal Diseases and Abnormalities →
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