Clinical trial NCT02163174: Pentoxifylline and Late Onset Sepsis in Preterm Infants
Official title: Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Late Onset Sepsis
Keywords: neonatal
pentoxifylline
randomized controlled trial
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal mortality
timeFrame: Expected 10 weeks postnatal age
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Expected average of 8 weeks post natal age
measure: Duration of respiratory support
timeFrame: Expected 4 to 6 weeks postnatal age
measure: Duration of antibiotics use
timeFrame: Expected 3 to 5 weeks postnatal age
measure: Chronic lung disease
timeFrame: By 36 weeks corrected gestational age
measure: Necrotising enterocolitis
timeFrame: Expected 6 weeks
measure: Intraventricular haemorrhage
timeFrame: Expected 2 weeks
measure: Periventricular leukomalacia
timeFrame: Expected 8 weeks
measure: Retinopathy of prematurity
timeFrame: Expected 8 weeks
measure: Serum levels of Tumor necrosis factor-α, C-Reactive protein
timeFrame: 6 days after intervention
measure: Adverse effects of Pentoxifylline
timeFrame: Up to 10 days after intervention
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
state: Eldakahlia
Study officials:
affiliation: Mansoura University, Faculty of Medicine
name: Abd Elazeez AT Shabaan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.