Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 21
- 主要终点
- Safety as Determined by Adverse Events
研究概览
简要总结
This study will describe the safety of furosemide in premature infants at risk of bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics (PK) of furosemide. Funding Source - FDA OOPD
详细描述
Infants will receive a placebo or furosemide for 28 days. Blood samples will be collected for pharmacokinetic analysis.Premature infants will be randomized to receive placebo or furosemide in a dose escalating approach.
Follow up information will be collected up to 7 days after the last dose and at 36 weeks post menstrual age. The final study assessment will occur at the time of discharge, early termination or transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional)
- •< 29 weeks gestational age at birth
- •7-28 days postnatal age at time of first study dose
排除标准
- •Exposure to any diuretic ≤ 72 hours prior to first study dose
- •Previous enrollment and dosing in current study, "Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia"
- •Hemodynamically significant patent ductus arteriosus, as determined by the investigator
- •Major congenital anomaly (e.g. congenital diaphragmatic hernia, congenital pulmonary adenomatoid malformation)
- •Meconium aspiration syndrome
- •Known allergy to any diuretic
- •Serum creatinine >1.7 mg/dL < 24 hours prior to first study dose
- •BUN >50 mg/dL < 24 hours prior to first study dose
- •Na <125 mmol/L < 24 hours prior to first study dose
- •K ≤2.5 mmol/L < 24 hours prior to first study dose
- •Ca ≤ 6 mg/dL < 24 hours prior to first study dose
- •Indirect bilirubin >10 mg/dL < 24 hours prior to first study dose
- •Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
Furosemide Cohort 1
Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.
干预措施: Furosemide Cohort 1 (Drug)
Placebo Cohort 1
Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
干预措施: Placebo (Other)
Furosemide Cohort 2
Cohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.
干预措施: Furosemide Cohort 2 (Drug)
Furosemide Cohort 3
Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.
干预措施: Furosemide Cohort 3 (Drug)
Placebo Cohort 2
Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
干预措施: Placebo (Other)
Placebo Cohort 3
Infants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
干预措施: Placebo (Other)
结局指标
主要结局
Safety as Determined by Adverse Events
时间窗: 35 days for each participant
Safety was assessed following the initial study-specific procedure (e.g., screening blood draws, dosing) through 7 days post last study dose by frequency and incidence of adverse events and serious adverse events.
次要结局
- Clearance(After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.)
- Moderate-Severe BPD or Death Risk Throughout Weekly Treatment(Risk measured weekly through Week 4)
- Area Under the Plasma Concentration Versus Time Curve(After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.)
- Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined(36 weeks postmenstrual age)
- Volume of Distribution(After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.)
- Half-life(After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.)