Neonates With Neurological Complications

Congenital Disorders Clinical Trial

Official title:

Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366561
• Other study ID #: 06-139
• Status: Completed
• Phase: N/A
• First received: August 17, 2006
• Last updated: November 26, 2014
• Start date: January 2002
• Est. completion date: April 2010

Study information

• Verified date: November 2014
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Disorders

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 years	No