Oral Versus Intravenous Ibuprofen Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
研究概览
简要总结
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.
详细描述
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight below 1000 gram
- •Diagnosed patent ductus arteriosis by Echocardiographic examination
排除标准
- •Accompanied other congenital cardiac anomalies
- •Severe thrombocytopenia < 60.000
- •Severe intracranial bleeding (Grade 3-4)
- •Intestinal abnormality and necrotising enterocolitis
研究组 & 干预措施
intravenous ibuprofen
Extremely low birth weight patients receiving iv ibuprofen
干预措施: oral ibuprofen (Drug)
Oral ibuprofen
Extremely low birth weight patients receiving oral ibuprofen
干预措施: oral ibuprofen (Drug)
结局指标
主要结局
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
时间窗: 6 months
To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment
次要结局
- Efficacy and Safety of Oral Versus Intravenous Ibuprofen(Results will be identified in 6 months)