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临床试验/NCT00366561
NCT00366561已完成不适用

Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery

Children's Healthcare of Atlanta1 个研究点 分布在 1 个国家目标入组 810 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
810
试验地点
1
主要终点
The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
— 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Those who do not meet inclusion criteria

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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