Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PDA pharmacological closure
研究概览
简要总结
Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.
详细描述
The objective of this trial is to compare the efficacy and safety of 2 therapeutic regimens for PDA treatment in a population of preterm newborns of gestational age (GA) <31+6 weeks with respiratory distress syndrome (RDS) and HsPDA:
- Group A: experimental boluses of paracetamol at 15 mg/Kg four time a day for three consecutive days.
- Group B: standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.
The primary objective of the study is: to evaluate the efficacy of paracetamol versus standard ibuprofen regimen, by comparing the rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria)
The secondary objective of the study is: to evaluate the safety of the above 2 therapeutic regimens in term of incidence of transient renal impairment, intraventricular hemorrhage (IVH) or other bleeding disorders, necrotizing enterocolitis (NEC) and isolated bowel perforation (without signs of NEC), incidence of sign of liver toxicity.
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
- 36 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn neonates
- •preterm neonates ≤ 31+ 6 days weeks gestation
- •newborns with HsPDA
- •parental written informed consent for participation in the study must be obtained
排除标准
- •Serum creatinine concentration greater than 1,5 mg/dl (132MMole/L)
- •Urine output less than 1 ml/Kg/h
- •Severe IVH (> grade II according to Volpe classification)
- •Clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate)
- •Necrotizing enterocolitis or marked abdominal distention with gastric bile residuals
- •Thrombocyte count of less than 50.000/mm3
- •Proved Sepsis
- •Severe coagulopathy or liver failure
- •Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0
- •Known genetic or chromosomal disorders
- •Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
研究组 & 干预措施
paracetamol
Boluses of intravenous paracetamol at 15 mg/Kg four time a day for three consecutive days.
干预措施: Intravenous paracetamol (Drug)
Intravenous ibuprofen
Standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three consecutive days.
干预措施: Intravenous ibuprofen (Drug)
结局指标
主要结局
PDA pharmacological closure
时间窗: Partecipants will be evaluated at the end of first and second course, at an expected avarage of 8 days of life (DOL)
The rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria) in paracetamol versus ibuprofen group
次要结局
- Oliguria(In the first 14 days of life)
研究者
Paola Lago
MD
University of Padova