NCT02163174已完成3 期
Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
Abd Elazeez Attala Shabaan1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Neonatal mortality
研究概览
简要总结
- Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
- The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
详细描述
- Role of pentoxifylline, a phosphodiesterase inhibitor, in reducing mortality associated with neonatal sepsis is not well studied.
- Hypothesis: we hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.
- Purpose of the study: to assess the efficacy and safety of Pentoxifylline as an adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
- Design: A prospective, randomized, double-blind clinical trial.
- Setting: Neonatal Intensive Care Unit, Mansoura University Children's Hospital.
- Patients: 120 preterm infants with suspected or confirmed LOS.
- Intervention: Enrolled infants were randomly assigned to receive intravenous Pentoxifylline (5 mg/kg/hr for 6 hours on 6 successive days) or placebo in addition to antibiotics.
- Primary outcome: Death before hospital discharge.
- Secondary outcomes: Length of hospital stay, duration of respiratory support, duration of antibiotics use, chronic lung disease, necrotizing enterocolitis, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, Serum levels of Tumor necrosis factor, C-Reactive protein levels, and adverse effects of Pentoxifylline.
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
- 年龄范围
- 5 Days 至 7 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis
排除标准
- •Preterm infants with major congenital malformations
- •Preterm infants with chromosomal anomalies
- •Preterm infants with inborn-errors of metabolism
- •Preterm infants with congenital infection
研究组 & 干预措施
Pentoxyfilline arm
Active Comparator
Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.
干预措施: Pentoxifylline (PTX) (Drug)
Placebo arm
Placebo Comparator
Intravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.
干预措施: Placebo (Drug)
结局指标
主要结局
Neonatal mortality
时间窗: Expected 10 weeks postnatal age
Mortality before discharge from neonatal intensive care unit
次要结局
- Length of hospital stay(Expected average of 8 weeks post natal age)
- Duration of respiratory support(Expected 4 to 6 weeks postnatal age)
- Duration of antibiotics use(Expected 3 to 5 weeks postnatal age)
- Chronic lung disease(By 36 weeks corrected gestational age)
- Necrotising enterocolitis(Expected 6 weeks)
- Intraventricular haemorrhage(Expected 2 weeks)
- Periventricular leukomalacia(Expected 8 weeks)
- Serum levels of Tumor necrosis factor-α, C-Reactive protein(6 days after intervention)
- Retinopathy of prematurity(Expected 8 weeks)
- Adverse effects of Pentoxifylline(Up to 10 days after intervention)
研究者
Abd Elazeez Attala Shabaan
Associate Professor of Pediatrics, Mansoura faculty of Medicine
Mansoura University
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Pentoxifylline for sepsis in newbornsCTRI/2023/01/048665Dr Deepak Chawla
招募中
3 期
evaluation effect of Pentoxifylline in sepsis.IRCT20180404039187N7Tabriz University of Medical Sciences40
Unknown
2 期
Pentoxifylline in the Treatment of NEC in Premature NeonatesNecrotizing EnterocolitisNCT00271336Shaare Zedek Medical Center50
招募中
不适用
Effect of pentoxifylline on inflammatory factors and quality of life in hemodialysis patientsIRCT20170609034406N3Tabriz University of Medical Sciences100
招募中
2 期
Prevention of acute respiratory problems in childreAcute Respiratory Distress Syndrome.Acute respiratory distress syndromeIRCT20190522043672N2Mashhad University of Medical Sciences40