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Clinical Trials/NCT00366561
NCT00366561
Completed
N/A

Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

Children's Healthcare of Atlanta1 site in 1 country810 target enrollmentJanuary 2002

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congenital Disorders
Sponsor
Children's Healthcare of Atlanta
Enrollment
810
Locations
1
Primary Endpoint
The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
April 2010
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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