临床试验/NCT03008876

NCT03008876已完成不适用

The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants

Albany Medical College1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2017年1月1日最近更新: 2019年7月8日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Albany Medical College
入组人数: 10
试验地点: 1
主要终点: Rate of PDA Closure

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.

研究设计

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

入排标准

年龄范围: 1 Minute 至 2 Weeks（Child）
性别: All
接受健康志愿者: 是

入选标准

•preterm infants 23-30 weeks gestation,
•PDA requiring treatment

排除标准

•infection,
•congenital heart disease,
•genetic syndrome,
•pulmonary hypertension,
•intestinal perforation,
•grade 3 or 4 IVH,
•serum creatinine >1.5,
•previous treatment with a COX inhibitor.

研究组 & 干预措施

acetaminophen

Experimental

Group of patients randomized to receive acetaminophen to treat their PDA

干预措施: Acetaminophen (Drug)

ibuprofen

Active Comparator

Group of patients randomized to receive ibuprofen to treat their PDA

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Rate of PDA Closure

时间窗: 3 days

PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

次要结局

Change in PDA size(3 days)

研究者

发起方

Albany Medical College

申办方类型

Other

责任方

Principal Investigator

主要研究者

Kate Tauber

Assistant Professor

Albany Medical College

研究点 (1)

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