EUCTR2013-003883-30-IT进行中（未招募）1 期
Efficacy and safety of paracetamol in comparison to ibuprofen for patent ductus arteriosus treatment in preterm infants. A randomized, open label, comparator-controlled, prospective study. - Paracetamol in Patent Ductus Arteriosus
Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A0 个研究点目标入组 109 人开始时间: 2013年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 109
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female preterm infants with no limitation of race.
- •Gestational age 25+0-31+6 weeks.
- •Age 24-72 hours.
- •Echocardiographic evidence of hemodynamically significant patent ductus arteriosus at the first 24-72 hours of life.
- •The diagnosis of hemodynamically significant PDA requiring treatment will be made by echocardiographic demonstration of a ductal left-to-right shunt, with a left atrium-to-aortic root ratio >1.3 or a ductal size >1.5 mm and excluding the cases in which the closing flow pattern suggests a restrictive PDA [Varvarigou 1996, Su 2008].
- •Willingness of the parents/legally authorized representative/child to sign the Informed Consent Form.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 110
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Outborn patients.
- •Major congenital anomalies, including but not limited to congenital heart defects, Down syndrome newborn and/or newborn suffering from congenital anomalies diagnosed during the fetal period.
- •Known positive HIV and/or known positive HCV newborn’s mother.
- •Life threatening infection, complicated or not by multiple organ dysfunction and failure syndrome.
- •Hydrops fetalis.
- •Pulmonary hypertension diagnosed in the first 24-48 hours of life by means of heart ultrasound when the presence of a right-to-left shunt through the foramen ovale or ductus arteriosus is demonstrated, or when the estimated pulmonary pressure, in terms of the tricuspid regurgitation jet, is greater than two-thirds of the systemic arterial pressure.
- •Grade 3 or 4 intraventricular haemorrhage (IVH).
- •Urine output <1 ml/kg of body weight/h during a 24 h collection period or urine output <0.5 ml/kg of body weight/h in case it is measured at 24 hours of life of newborn.
- •Serum creatinine concentration > 1.5 mg/dl (132 µmol/l).
- •Platelet count < 50,000/mm3.
- •Major bleeding, as revealed by haematuria, or blood in the endotracheal aspirate, gastric aspirate, or stools, or consistent oozing of blood from puncture sites.
- •Severe liver failure, defined as elevated liver enzymes (ALT/GPT and AST/GOT) > 2 times the upper boundary of the normal range. For this kind of population the following normal ranges will be considered [Rosenthal, 1997]:
- •- ALT/GPT: 6-50 U/L
- •- AST/GOT: 35-140 U/L
- •Medical need of administering other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) different from ibubrofen.
- •Participation to another trial involving any investigational drug.
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