New Therapeutic Approaches to the Resistant Patent Ductus Arteriosus (PDA) in Low Birth Weight Neonates
试验速览
- 阶段
- 2 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Our primary objective in this study is to improve ductal closure rates in those infants who do not respond to a first course of therapy.
研究概览
简要总结
Persistent postnatal ductal patency may have significant adverse hemodynamic effects, frequently necessitating therapeutic intervention in order to facilitate ductal closure. Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure in approximately 70% of treated infants. In a recent study in our population, 17% of the babies showed no ductal response to the first course of treatment and 9.4% of our study infants eventually underwent surgical ligation of the ductus after failure of medical therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches to ductal closure in babies who do not respond to initial therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Days 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inborn premature neonates admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as having a hemodynamically significant patent ductus arteriosus (sPDA) will be considered as potential candidates for study if/when they do not respond to initial therapy
排除标准
- •Any baby not considered viable
- •Any baby with IVH grade 3-4 of recent onset (within 3 days. [If no head ultrasound has been performed within the last 3-4 days, one should performed prior to onset of study.]
- •Any baby with dysmorphic features or congenital abnormalities
- •Any baby with structural heart disease other than PDA
- •Any baby with documented infection,
- •Any baby with thrombocytopenia (<50,000).
研究组 & 干预措施
Stepwise Indo
Stepwise escalating doses of indomethacin, until ductal closure or maximum of 1 mg/kg/dose.
干预措施: Indomethacin (Drug)
PTX
Combined administration of indomethacin and pentoxifylline, an inhibitor of TNF alpha
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
Our primary objective in this study is to improve ductal closure rates in those infants who do not respond to a first course of therapy.
时间窗: 2 years
次要结局
- Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols.(2 years)
- To monitor and compare potential side effects of the two treatment approaches(2 years)