Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Area under the curve from serial Indomethacin levels
研究概览
简要总结
This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates <27 weeks' gestational age.
详细描述
Neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open PDA (with no other contraindications for indomethacin treatment). After enrollment, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. Indomethacin levels will be measured at regular intervals. Urine output and serum electrolytes will be monitored prior to each dose of indomethacin. An echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of PDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 26 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infant born between 23 (0/7) and 26 (6/7) week GA
- •Infant diagnosed with PDA according to clinical protocol criteria
- •Able to adhere to indomethacin administration protocol
- •The patient is born in the study center.
- •Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
- •In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
排除标准
- •known major congenital malformations (renal, cardiac, gastrointestinal and central nervous system)
- •genetic syndromes-inborn errors of metabolism
- •severe renal compromise
- •intrauterine growth retardation with birth weight <3rd centile
- •thrombocytopenia <50,000/mm3
- •moderate to severe pulmonary hypertension
- •clinical sepsis -meningitis- hepatitis
- •anticipated drug-drug-interactions (specifically CYP2C9, CYP2C19 and UGT 1-1)
研究组 & 干预措施
Neonates with an open PDA
Neonates born between 23 (0/7) and 26 (6/7) weeks gestational age with an open PDA, according to clinical protocol criteria, and no contraindication to the use of indomethacin.
干预措施: Indomethacin Injection (Drug)
结局指标
主要结局
Area under the curve from serial Indomethacin levels
时间窗: At 48 hour following the last dose
Blood samples will be drawn from patients to determine the serum indomethacin levels to determine the area under the curve
次要结局
- Percentage of Participants with Intraventricular hemorrhage(Within the first 7 days of life.)
- Percentage of Participants with Adverse Events(trough hospital discharge, an average of up to 36 weeks gestational age)
- Percentage of Participants with Patent Ductus Arteriosus Closure(Within 48 hrs after the last dose)
- Duration of mechanical ventilation of each patient(trough hospital discharge, an average of up to 36 weeks gestational age)