跳至主要内容
临床试验/NCT06126484
NCT06126484招募中不适用

Outcomes of Transcatheter Cardiac Interventions in Neonates With Congenital Heart Disease at Sohag University Hospital

Sohag University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
procedure related complications

研究概览

简要总结

This study is performed to assess the safety, efficacy and outcome of transcatheter cardiac interventions in neonates with critical congenital heart disease at Sohag University Hospital

详细描述

This study includes neonates with critical congenital heart diseases that require early interventions Patients with untreated sepsis and coagulopathy are excluded.

Methods:

A) Clinical data: age, body weight and oxygen saturation B) Echocardiographic data: cardiac anatomical diagnosis. C) Catheterization data: vascular access, description of the defects, type of the device used, fluoroscopy time, radiation time, related complications and added interventions in the same setting.

D) Procedural details:

  • All procedures will be performed under general anesthesia. procedures will be performed are;

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Neonates with critical congenital heart diseases that require early intervention

排除标准

  • Untreated sepsis and coagulopathy.

结局指标

主要结局

procedure related complications

时间窗: 1 day

complications that may occur during or after procedure

次要结局

  • Postprocedure NICU admission(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Somia Sabry Mahmoud

Assistant lecturer of Pediatrics

Sohag University

研究点 (2)

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