Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA
研究概览
简要总结
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
详细描述
To determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
One of the following echocardiographic criteria of a duct size > 1.5 mm, a left atrium-to-aorta ratio > 1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.
Three consecutive blood sample from infants for 3 days before dose application of drugs(ibuprofen and paracetamol will be obtained.
The relation of pharmacokinetics of drugs to drug response will be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight below 1250 gram
- •Diagnosed patent ductus arteriosus by Echocardiographic examination
排除标准
- •Accompanied other congenital cardiac anomalies
- •Severe thrombocytopenia < 60.000
- •Severe intracranial bleeding (Grade III - IV)
- •Intestinal abnormality and necrotising enterocolitis
研究组 & 干预措施
Oral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days
干预措施: Oral paracetamol (Drug)
Oral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
干预措施: Oral ibuprofen (Drug)
结局指标
主要结局
To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA
时间窗: up to 6 months
The measurement of Serum levels of Paracetamol and Ibuprofen in preterm infants treated with Oral Paracetamol and Oral Ibuprofen. To determine of effective serum levels of paracetamol and ibuprofen for treatment of patent ductus arteriosus in preterm infants. In normally, effective and safely dose of NSAIDs for treatment of PDA are exactly unknown. Therefore we will detected cut-off serum levels for effective, safely and hazardous.
次要结局
未报告次要终点
研究者
Sadik Yurttutan
Zekai Tahir Burak Maternity and Teaching Hospital
Zekai Tahir Burak Women's Health Research and Education Hospital