This trial is active, not recruiting.

Condition congenital disorders
Sponsor Children's Healthcare of Atlanta
Start date January 2002
Trial size 1000 participants
Trial identifier NCT00366561, 06-139


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective retrospective

Eligibility Criteria

Male or female participants up to 30 days old.

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

Additional Information

Official title Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery
Principal investigator Janet M Simsic, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Children's Healthcare of Atlanta.