Neonatal Late Onset Sepsis
Conditions
Keywords
neonatal, pentoxifylline, randomized controlled trial
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.
Interventions
Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics
DRUGPlacebo
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.
Sponsors
Abd Elazeez Attala Shabaan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Days to 7 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal mortality | Expected 10 weeks postnatal age | Mortality before discharge from neonatal intensive care unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of hospital stay | Expected average of 8 weeks post natal age | Duration of hospital admission (days) |
| Periventricular leukomalacia | Expected 8 weeks | By cranial ultrasound |
| Retinopathy of prematurity | Expected 8 weeks | Ophthalmologist using Ret-Cam |
| Serum levels of Tumor necrosis factor-α, C-Reactive protein | 6 days after intervention | — |
| Adverse effects of Pentoxifylline | Up to 10 days after intervention | Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis. |
| Intraventricular haemorrhage | Expected 2 weeks | By cranial ultrasound grading |
Countries
Egypt
Outcome results
None listed