Pentoxifylline and Late Onset Sepsis in Preterm Infants

Neonatal Late Onset Sepsis Clinical Trial

Official title: Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.

Status Completed

Clinical Trial Summary

• 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.

Clinical Trial Description

• 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Late Onset Sepsis
• Sepsis

• NCT number: NCT02163174
• Study type: Interventional
• Source: Mansoura University
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Completion date: June 2013