Nebulized Furosemide in Premature Infants With Bronchopulmonary Dysplasia - A Cross Over Pilot Study of Its Efficacy and Safety
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Daily percent change from pre-treatment FiO2 requirement measurement.
研究概览
简要总结
This is a prospective,randomized, cross over study comparing the efficacy and safety of nebulizedfurosemide with Intra Venous (IV)furosemide in preterm infants who areventilator-and oxygen dependent. Reviewing the patient census on Neo data by the Sub Investigator will identify the potential subjects. Subject will be randomized to either A arm or B arm. Subjects in the A arm will receive 1 mg/kg of inhaled furosemideQ 24 hours for 3 days. This will be followed by a washout period of a day followed by 1mg/kg of intravenous furosemide Q 24 hours for 3 days. Subjects in the B arm will receive 1 mg/kg of intravenous furosemide Q 24 hours for 3 days followed by a washout period, which is then followed by 1 mg/kg of inhaled furosemide Q 24 hours for 3 days.
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
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are born prematurely at<34 weeks of gestation
- •Subjects who are at least 14days old, on Oxygen and mechanical ventilation.
- •Radiologic evidence of pulmonary parenchymal disease
- •The NICU medical team to start furosemide administration as a part of the routine clinical management
排除标准
- •Subjects who have received any diuretics;IV or PO for 48 hoursbefore the study initiation
- •Subjects with congenital heart disease withR-L shunts.
- •Subjects with acute sepsis.
- •Subjects with kidney diseasedefined by creatinine > 1mg/dl or oliguria, defined as urine output < 0.6 ml/kg/hour
- •Subjects with necrotizing enterocolitis (NEC)or suspected NEC
- •Subjects with congenital malformations.Subjects who are receiving steroids, or have received steroids in the last 7 days(patients need to be off steroids for at least 7 days).
研究组 & 干预措施
Arm B
干预措施: Intravenous Furosemide (Drug)
Arm A
干预措施: Inhaled Furosemide (Drug)
结局指标
主要结局
Daily percent change from pre-treatment FiO2 requirement measurement.
时间窗: days 1, 2, 3, 5, 6, and 7
Measurements will be taken twice within a two-hour window before and after treatment as applicable. On baseline day and the washout day, two measurements will be also taken within the two-hour window to compute percent change for the day
次要结局
未报告次要终点