Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PDA closure after 1 week
研究概览
简要总结
The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
详细描述
Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
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
- 20 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term newborn (37 weeks of gestation or more)
- •Age between 20-28 days
- •confirmed diagnosis of PDA by echocardiography by pediatric cardiologist
排除标准
- •Hemorrhage
- •Platelet count < 150000
- •renal or gastrointestinal malformations
- •associated congenital heart disease
研究组 & 干预措施
Oral Ibuprofen
10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
干预措施: Oral Ibuprofen (Drug)
结局指标
主要结局
PDA closure after 1 week
时间窗: 1 weeks after treatment
PDA closure after 1 week of treatment based on echocardiography
PDA closure after two weeks
时间窗: 2 weeks after treatment
PDA closure two weeks after treatment based on echocardiography
次要结局
- Drug side effects(two weeks after treatment)
研究者
Hamidreza Mahboobi
Principal Investigator
Hormozgan University of Medical Sciences