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CompletedNCT02163174Updated Jun 16, 2014

Pentoxifylline and Late Onset Sepsis in Preterm Infants

A Phase 3 interventional study of Pentoxifylline (PTX) and Placebo in Neonatal Late Onset Sepsis, sponsored by Abd Elazeez Attala Shabaan. Completed at 1 site in Egypt. Open to participants aged 5 Days to 7 Weeks. Per ClinicalTrials.gov, last updated 2014-06-16.

Sponsored by Abd Elazeez Attala Shabaan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
5 Days to 7 Weeks
Sex
All
01

Study 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.
Read the 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.
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Conditions studied

  • Neonatal Late Onset Sepsis

Keywords

  • neonatal
  • pentoxifylline
  • randomized controlled trial
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 120 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

This is the only study on the registry with Abd Elazeez Attala Shabaan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Days to 7 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Pentoxyfilline arm

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

    Drug: Pentoxifylline (PTX)

  • Placebo comparator
    Placebo arm

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

    Drug: Placebo

Interventions

  • DrugPentoxifylline (PTX)

    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)

  • 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.

06

What researchers measure

Primary outcomes

  1. Neonatal mortality

    Mortality before discharge from neonatal intensive care unit

    Time frame: Expected 10 weeks postnatal age

Secondary outcomes

  1. Length of hospital stay

    Duration of hospital admission (days)

    Time frame: Expected average of 8 weeks post natal age

  2. Duration of respiratory support

    Duration of respiratory support including oxygen, Continuous Positive Airway Pressure, mechanical ventilation(days)

    Time frame: Expected 4 to 6 weeks postnatal age

  3. Duration of antibiotics use

    Duration of treatment of sepsis including meningitis

    Time frame: Expected 3 to 5 weeks postnatal age

  4. Chronic lung disease

    Need for oxygen by 36 weeks corrected gestational age

    Time frame: By 36 weeks corrected gestational age

  5. Necrotising enterocolitis

    Bell clinical and radiological criteria

    Time frame: Expected 6 weeks

  6. Intraventricular haemorrhage

    By cranial ultrasound grading

    Time frame: Expected 2 weeks

  7. Periventricular leukomalacia

    By cranial ultrasound

    Time frame: Expected 8 weeks

  8. Retinopathy of prematurity

    Ophthalmologist using Ret-Cam

    Time frame: Expected 8 weeks

  9. Serum levels of Tumor necrosis factor-α, C-Reactive protein

    Time frame: 6 days after intervention

  10. Adverse effects of Pentoxifylline

    Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis.

    Time frame: Up to 10 days after intervention

07

Study locations

1 site
  • Mansoura University Children Hospital
    Mansoura, Eldakahlia 35516, Egypt
08

References and documents

Publications

  • 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. PubMed 25970116 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02163174
Lead sponsor
Abd Elazeez Attala Shabaan
Responsible party
Abd Elazeez Attala Shabaan (Associate Professor of Pediatrics, Mansoura faculty of Medicine, Mansoura University) — Sponsor-investigator
First posted
Jun 13, 2014
Start date
May 2011
Primary completion
Feb 2013
Completion
Jun 2013
Last update
Jun 16, 2014

Study contacts

Abd Elazeez AT Shabaan, PhD
principal investigator · Mansoura University, Faculty of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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