Pentoxifylline and Late Onset Sepsis in Preterm Infants

Neonatal Late Onset Sepsis Clinical Trial

Official title:

Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163174
• Other study ID #: 12345
• Secondary ID: R88
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2014
• Last updated: June 12, 2014
• Start date: May 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Late Onset Sepsis
• Sepsis

Intervention

Drug:
• Pentoxifylline (PTX)
Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics
• Placebo
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.

Locations

Country	Name	City	State
Egypt	Mansoura University Children Hospital	Mansoura	Eldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Abd Elazeez Attala Shabaan

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality	Mortality before discharge from neonatal intensive care unit	Expected 10 weeks postnatal age	No
Secondary	Length of hospital stay	Duration of hospital admission (days)	Expected average of 8 weeks post natal age	No
Secondary	Duration of respiratory support	Duration of respiratory support including oxygen, Continuous Positive Airway Pressure, mechanical ventilation(days)	Expected 4 to 6 weeks postnatal age	No
Secondary	Duration of antibiotics use	Duration of treatment of sepsis including meningitis	Expected 3 to 5 weeks postnatal age	No
Secondary	Chronic lung disease	Need for oxygen by 36 weeks corrected gestational age	By 36 weeks corrected gestational age	No
Secondary	Necrotising enterocolitis	Bell clinical and radiological criteria	Expected 6 weeks	No
Secondary	Intraventricular haemorrhage	By cranial ultrasound grading	Expected 2 weeks	No
Secondary	Periventricular leukomalacia	By cranial ultrasound	Expected 8 weeks	No
Secondary	Retinopathy of prematurity	Ophthalmologist using Ret-Cam	Expected 8 weeks	No
Secondary	Serum levels of Tumor necrosis factor-a, C-Reactive protein		6 days after intervention	No
Secondary	Adverse effects of Pentoxifylline	Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis.	Up to 10 days after intervention	Yes