Pentoxifylline and Late Onset Sepsis in Preterm Infants

NCT02163174 | Completed Phase 3

• 2 other identifiers: 12345R88
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Late Onset Sepsis

Keywords

neonatal; pentoxifylline; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Neonatal mortality

  Mortality before discharge from neonatal intensive care unit

  Expected 10 weeks postnatal age

Secondary Outcomes (10)

• Length of hospital stay

  Expected average of 8 weeks post natal age

• Duration of respiratory support

  Expected 4 to 6 weeks postnatal age

• Duration of antibiotics use

  Expected 3 to 5 weeks postnatal age

• Chronic lung disease

  By 36 weeks corrected gestational age

• Necrotising enterocolitis

  Expected 6 weeks

Study Arms (2)

Pentoxyfilline arm

ACTIVE COMPARATOR

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

Drug: Pentoxifylline (PTX)

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pentoxifylline (PTX) DRUG

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

Also known as: Trental (brand name)

Pentoxyfilline arm

Placebo 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.

Placebo arm

Eligibility Criteria

• Age: 5 Days - 7 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Appropriate for gestational age preterm infants with suspected or confirmed late onset sepsis

You may not qualify if:

• Preterm infants with major congenital malformations
• Preterm infants with chromosomal anomalies
• Preterm infants with inborn-errors of metabolism
• Preterm infants with congenital infection

Sponsors & Collaborators

• Abd Elazeez Attala Shabaan: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, Eldakahlia, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 25970116 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Abd Elazeez AT Shabaan, PhD

  Mansoura University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Mansoura faculty of Medicine

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 13, 2014
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

EG (1)