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临床试验/NCT02910609
NCT02910609Unknown不适用

International Experience in Timing And Choices of Treatment For Ductal Closure in Patent Ductus Arteriosus: INTERPDA Trial

Ankara University0 个研究点目标入组 1,000 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
主要终点
Spontan closure rate

研究概览

简要总结

The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.

详细描述

Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants.

In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.

Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.

Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born at 24 0/7-28 6/7 gestation weeks'
  • PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life

排除标准

  • Infants died before 72 hours of life
  • Infants detected PDA but treated before 72 hours of life

结局指标

主要结局

Spontan closure rate

时间窗: 3 months

Rate of patients with spontaneous ductal closure

次要结局

  • Surgical ligation rate(3 months)
  • Complications of prematurity(3 months)

研究者

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

Omer Erdeve

Ankara University, Clinical Profesor

Ankara University

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