NCT02128191已完成2 期
Efficacy and Safety of No Treatment Compared With Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants: a Randomized, Double-blind, Placebo-controlled, Non-inferiority Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)
详细描述
This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age of 30 weeks or less or birth weight of 1250 g or less
- •born in Samsung Medical Center
- •confirmed to have hemodynamically significant patent ductus arteriosus (PDA) during day of life (DOL) 5 to 14
- •Definition of hemodynamically significant PDA: ductal size ≥ 1.5 mm with left-to-right shunt (or bidirectional shunt with dominant left-to-right blood flow) on the initial echocardiography plus at least one of clinical criteria.
- •Clinical criteria
- •Respiratory signs, including tachypnea, chest retraction, increased respiratory support, unable to wean respiratory support
- •Physical signs, including a murmur, hyperdynamic precordium or bounding pulses
- •Blood pressure problems, including decreased mean or diastolic pressure or increased pulse pressure
- •Signs of congestive heart failure, including cardiomegaly, hepatomegaly or pulmonary congestion
排除标准
- •Mortality within the first 48 hours of life
- •Ductal size < 1.5 mm on the initial echocardiography
- •Right-to-left shunt or bidirectional shunting with dominant right-to-left shunt through PDA
- •congenital anomaly
- •bilateral intraventricular hemorrhage of grade 4
- •contraindication of ibuprofen (bleeding diasthesis, platelet count 10,000/mm3 or less, serum creatinine 2.0 mg/dL or greater, necrotizing enterocolitis stage 2 or greater
研究组 & 干预措施
Oral ibuprofen
Active Comparator
Initial dose of 10 mg/kg of oral ibuprofen, followed by 2 doses of 5 mg/kg 24 and 48 h later
干预措施: Oral ibuprofen (Drug)
Normal saline
Placebo Comparator
Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
时间窗: 36 weeks PMA
次要结局
- Incidence of oxygen dependency at 40 weeks PMA(40 weeks PMA)
- Duration of PDA(40 weeks PMA (± 2 weeks))
- Duration of intubation(36 weeks PMA)
- incidence of intraventricular hemorrhage (grade 3 or greater)(28-days since birth)
- Growth velocity(40 weeks PMA (± 2 weeks))
- Duration of nasal continuous positive airway pressure (NCPAP) treatment(40 weeks PMA (± 2 weeks))
- Incidence of adverse events(participants will be followed for the duration of hospital stay, an expected average of 12 weeks)
- Incidence of necrotizing enterocolitis (stage 2b or greater)(40 weeks PMA (± 2 weeks))
- Incidence of moderate to severe BPD(36 weeks PMA)
- Mortality rate(28-days since birth and 36 weeks PMA)
- Incidence of retinopathy of prematurity (stage III or greater)(40 weeks PMA (± 2 weeks))
- Cumulative duration of oxygen use(40 weeks PMA (± 2 weeks))
研究者
Se In Sung
M.D.
Samsung Medical Center
研究点 (1)
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