Pentoxifylline and Late Onset Sepsis in Preterm Infants
- Conditions
- Neonatal Late Onset Sepsis
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis
- 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 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
Necrotising enterocolitis Expected 6 weeks Bell clinical and radiological criteria
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