ACTRN12606000257561撤回2 期
Safety and efficacy of pentoxifylline as a treatment for preventing the progression of necrotising enterocolitis in preterm neonates– A randomised, placebo controlled pilot trial
KEM Hospital for Women, Perth0 个研究点目标入组 80 人开始时间: 2006年6月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- ot stated 至 32 Weeks（—）
- 性别
- All
入选标准
- •(1) Preterm neonates with at or greater than Stage II (definite) NEC will be eligible for enrolment as soon as the diagnosis is made and (2) Informed parental consent is obtained and (3) At least one cranial ultrasound has been performed prior to the diagnosis of NEC as routine surveillance for IVH or any other intracranial pathology.
排除标准
- •(1) Failure to obtain informed parental consent (2) Presence of major congenital malformation/s (3) Presence of chromosomal aberrations (4) Presence of *hepatic impairment (Elevated serum aminotransaminase, alkaline phosphatase, and/or ammonia levels to >2.5 times the normal in presence of prolonged prothrombin and partial thromboplastin time) (5) Presence of *renal impairment (Blood urea nitrogen > 30 mg/dl, urine output <0.6 ml/kg/hour for at least 6 hours, and creatinine > 0.8 mg/dL) *Normal values (ALT: 3-54 U/L, AST: 10-65 U/L, Alkaline phosphatase: 110-400 U/L, Ammonia: 20-80 ?g/dL) and definitions of hepatic and renal impairment: Ref: Appendix A and D: 732-3 In Manual of Neonatal Care, Fifth Edition 2004, Eds: Cloherty JP, Eichenwald EC, Stark AR.
研究者
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