NCT07088328尚未招募不适用
Effect of Pentoxyphylline in Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Renal function
研究概览
简要总结
The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler sonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Evidence of perinatal hypoxia, as indicated by at least one of the following:
- •Apgar score of less than or equal to 5 at 10 minutes.
- •ongoing resuscitation at 10 minutes.
- •pH less than 7.14 or a base deficit worse than or equal to minus 12 mmol/L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth.
- •Evidence of moderate to severe encephalopathy using Sarnat staging score.(14)
- •Greater than or equal to 35 weeks gestational age.
- •Birth weight greater than or equal to 1800 g.
排除标准
- •Neonates with any of the following will be excluded:
- •Birth weight less than 1800 g.
- •Major congenital malformations/chromosomal anomalies including major cardiac anomalies.
- •Preterm less than 35 weeks gestational age according to modified Ballard score. (15)
- •progressive neuromuscular disorders (eg spinal muscle atrophy).
- •Severe systemic infections (eg TORCH infection).
研究组 & 干预措施
Pentoxifylline group
Active Comparator
They will be given pentoxifylline as reno-protective drug (trentoximal, Egypharma ; E.D.A Reg.No.: 25276/2007) was administered intravenously to Neonates with perinatal hypoxia at 5mg/kg/hr given over 6 h daily for 3 consecutive days
干预措施: Pentoxifylline (Drug)
Control group
Placebo Comparator
They will not be given pentoxifylline as reno-protective drug
干预措施: placebo distilled water (Other)
结局指标
主要结局
Renal function
时间窗: daily in the first 3 days of life.
creatinine level in mg/dl.
次要结局
- Renal Doppler sonography(first 3 days of life)
- cystatin C(first 24 hours of life)
研究者
Marwa Mohamed Farag
Assistant professor of Pediatrics
Alexandria University
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