Clinical Trials Directory

Trials / Completed

CompletedNCT00366561

Neonates With Neurological Complications

Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
810 (actual)
Sponsor
Children's Healthcare of Atlanta · Academic / Other
Sex
All
Age
30 Days
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Timeline

Start date
2002-01-01
Primary completion
2010-04-01
Completion
2010-04-01
First posted
2006-08-21
Last updated
2014-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00366561. Inclusion in this directory is not an endorsement.