Pentoxifylline and Late Onset Sepsis in Preterm Infants

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.

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.

Intravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.

Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics

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.

Duration of respiratory support including oxygen, Continuous Positive Airway Pressure, mechanical ventilation(days)

Inclusion Criteria: - Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis Exclusion Criteria: Preterm infants with major congenital malformations Preterm infants with chromosomal anomalies Preterm infants with inborn-errors of metabolism Preterm infants with congenital infection

Shabaan AE, Nasef N, Shouman B, Nour I, Mesbah A, Abdel-Hady H. Pentoxifylline therapy for late-onset sepsis in preterm infants: a randomized controlled trial. Pediatr Infect Dis J. 2015 Jun;34(6):e143-8. doi: 10.1097/INF.0000000000000698.