Pentoxifylline in the Treatment of Necrotizing Enterocolitis in Premature Neonates
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To demonstrate that fewer of the babies who are treated with PTX will progress to serious NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement], and/or death related to NEC.
研究概览
简要总结
Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.
详细描述
Preterm neonates with a clinical suspicion of necrotizing enterocolitis (NEC) will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group: to receive IV pentoxifylline (5 mg/kg/hour to run over 6 hour x 6 days) and 2. Placebo group: to receive an equal volume of ½ normal saline to run over 6 hours x 6 days.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants <1750 gm. birth weight
- •Abdominal x-ray consistent with NEC (dilated loops, bowel wall edema, fixed or persistent dilated loop with (or without pneumatosis)
排除标准
- •Abdominal perforation
研究组 & 干预措施
A
干预措施: Pentoxifylline (Drug)
B
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
To demonstrate that fewer of the babies who are treated with PTX will progress to serious NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement], and/or death related to NEC.
时间窗: Three years
次要结局
- To demonstrate lower levels of TNF alpha,fecal calprotectin;Improved SMA blood flow;Quicker radiographic resolution; Decreased feeding intolerance after acute NEC episode; and lower NEC associated long term morbidity.(Three years)