Pentoxifylline and Late Onset Sepsis in Preterm Infants

Abd Elazeez Attala Shabaan

Status and phase: Completed; Phase 3

Conditions: Neonatal Late Onset Sepsis

Treatments: Drug: Placebo; Drug: Pentoxifylline (PTX)

Study type: Interventional

Funder types: Other

Identifiers

NCT02163174

R88 (Other Identifier)

12345

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 5 days to 7 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Pentoxyfilline arm

Active Comparator group

Description:

Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.

Treatment:

Drug: Pentoxifylline (PTX)

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo