Neonates With Neurological Complications

Completed

• Conditions: Congenital Disorders

• Registration Number: NCT00366561
• Lead Sponsor: Children's Healthcare of Atlanta

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.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-21
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 810

Inclusion Criteria

• Children's Healthcare of Atlanta patients
• January 1, 2002 through June 20, 2006
• < 30 days of age
• neurological complications following cardiac surgery

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Exclusion Criteria

• Those who do not meet inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.	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.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States