Ibuprofen and Renal Function in Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Creatinine Clearance on day seven postnatally
研究概览
简要总结
Purpose of the study:
- To evaluate renal function maturation within the first month of life in very premature infants.
- To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
详细描述
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication. However, experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants.
Purpose of the study:
- To evaluate renal function maturation within the first month of life in very premature infants.
- To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.
Population:
At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording of mother and child history, and associated therapies prone to alter renal function should allow to improve the use of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational Age = 27 to 31 weeks
- •Postnatal age < 48 hours
- •Parental Consent Obtained
排除标准
- •Renal malformation
- •Urinary tract infection
- •Renal Failure
- •Pulmonary Hypertension at echocardiography
结局指标
主要结局
Creatinine Clearance on day seven postnatally
次要结局
- Rate of ductus closure after treatment
- Mortality
- Rate of necrotizing enterocolitis
- Rate and severity of Intraventricular Hemorrhage
- Renal function maturation over 28 days