Pentoxifylline and Late Onset Sepsis in Preterm Infants

Phase 3

Completed

• Conditions: Neonatal Late Onset Sepsis
• Interventions: Drug: Pentoxifylline (PTX); Drug: Placebo

• Registration Number: NCT02163174
• Lead Sponsor: Abd Elazeez Attala Shabaan

Brief 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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-02
• Study Completion: 2013-06
• Status Verified: 2014-06
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-11
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentoxyfilline arm	Pentoxifylline (PTX)	Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.
Placebo arm	Placebo	Intravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.

Primary Outcome Measures

Name	Time	Method
Neonatal mortality	Expected 10 weeks postnatal age	Mortality before discharge from neonatal intensive care unit

Secondary Outcome Measures

Name	Time	Method
Necrotising enterocolitis	Expected 6 weeks	Bell clinical and radiological criteria
Length of hospital stay	Expected average of 8 weeks post natal age	Duration of hospital admission (days)
Duration of respiratory support	Expected 4 to 6 weeks postnatal age	Duration of respiratory support including oxygen, Continuous Positive Airway Pressure, mechanical ventilation(days)
Duration of antibiotics use	Expected 3 to 5 weeks postnatal age	Duration of treatment of sepsis including meningitis
Chronic lung disease	By 36 weeks corrected gestational age	Need for oxygen by 36 weeks corrected gestational age
Intraventricular haemorrhage	Expected 2 weeks	By cranial ultrasound grading
Periventricular leukomalacia	Expected 8 weeks	By cranial ultrasound
Serum levels of Tumor necrosis factor-α, C-Reactive protein	6 days after intervention
Retinopathy of prematurity	Expected 8 weeks	Ophthalmologist using Ret-Cam
Adverse effects of Pentoxifylline	Up to 10 days after intervention	Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis.

Trial Locations

Locations (1)

Mansoura University Children Hospital; 🇪🇬 Mansoura, Eldakahlia, Egypt