NCT02163174

Pentoxifylline and Late Onset Sepsis in Preterm Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Abd Elazeez Attala Shabaan · Academic / Other
• Sex: All
• Age: 5 Days – 7 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neonatal Late Onset Sepsis

Interventions

Type	Name	Description
DRUG	Pentoxifylline (PTX)	Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics
DRUG	Placebo	Patients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-02-01
• Completion: 2013-06-01
• First posted: 2014-06-13
• Last updated: 2014-06-16

Locations

1 site across 1 country: Egypt