Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percentage of infants with PDA closure.
研究概览
简要总结
Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.
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 (Investigator)
入排标准
- 年龄范围
- 23 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams
- •Hemodynamically significant PDA as defined by any of the following:
- •Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
- •Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
- •Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
- •Echocardiographic criteria:
- •Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5
排除标准
- •No enteral feedings
- •PDA-dependent congenital heart disease
- •Prior treatment with prophylactic indomethacin
- •Prior PDA treatment with any medications
- •Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
- •Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)
- •Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
- •Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
- •Prior enrollment to other interventional clinical study where PDA is an outcome variable
研究组 & 干预措施
Ibuprofen+Acetaminophen Group
Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses).
干预措施: Intravenous Ibuprofen + Oral Acetaminophen (Drug)
Ibuprofen Group
Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone.
干预措施: Intravenous Ibuprofen (Drug)
结局指标
主要结局
Percentage of infants with PDA closure.
时间窗: During hospitalization, up to 10 days
Percentage of patients who demonstrated PDA closure.
次要结局
未报告次要终点