Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Oxygen saturation
研究概览
简要总结
After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is accessed via a cut pig-tail or Judkins right [JR] catheter, and is crossed by PTCA wire to be carefully placed in the left or right branch pulmonary arteries, choose proper stent diameter and length, place the stent and confirm it's position, NICU admission for the neonate with heparin infusion for 24-48 hrs and acetylsalicylic acid is given then follow up the patient by pulse oximeter and echocardiography
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 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates and young infants with duct dependent pulmonary circulation
排除标准
- •Untreated sepsis.
- •Coagulopathy.
- •PDA dependent systemic circulation.
研究组 & 干预措施
Cyanotic neonate
Cyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation
干预措施: Catheter-guided PDA stent implantation (Device)
结局指标
主要结局
Change in Oxygen saturation
时间窗: Change in oxygen saturation within 24 hours
Using pulse oximeter to assess oxygen saturation
Evaluation of duct patency
时间窗: 1 month
Using echocardiography assess flow through the duct
次要结局
未报告次要终点
研究者
Somia Sabry Mahmoud
Assistant lecturer
Sohag University