Pentoxifylline and Late Onset Sepsis in Preterm Infants

NCT ID: NCT02163174

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Neonatal Late Onset Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pentoxyfilline arm

Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.

Group Type: ACTIVE_COMPARATOR

Pentoxifylline (PTX)

Intervention Type: DRUG

Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics

Placebo arm

Intravenous saline as a Placebo 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Trental (brand name)

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

• Minimum Eligible Age: 5 Days
• Maximum Eligible Age: 7 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abd Elazeez Attala Shabaan

OTHER

Sponsor Role: lead

Responsible Party

Abd Elazeez Attala Shabaan

Associate Professor of Pediatrics, Mansoura faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abd Elazeez AT Shabaan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Faculty of Medicine

Locations

Mansoura University Children Hospital

Al Mansurah, Eldakahlia, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 25970116 (View on PubMed)

Other Identifiers

R88

Identifier Type: OTHER

Identifier Source: secondary_id

12345

Identifier Type: -

Identifier Source: org_study_id