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Completed

NCT Number: NCT02163174

Pentoxifylline and Late Onset Sepsis in Preterm Infants

* 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.

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Key information

Conditions

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

Age range

5 day–7 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mansoura University Children Hospital

Al Mansurah, Eldakahlia, 35516, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Trental (brand name)

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.

Primary outcomes

  1. Neonatal mortality

    Time frame: Expected 10 weeks postnatal age

    Mortality before discharge from neonatal intensive care unit

Secondary outcomes

  1. Length of hospital stay

    Time frame: Expected average of 8 weeks post natal age

    Duration of hospital admission (days)

  2. Duration of respiratory support

    Time frame: Expected 4 to 6 weeks postnatal age

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

  3. Duration of antibiotics use

    Time frame: Expected 3 to 5 weeks postnatal age

    Duration of treatment of sepsis including meningitis

  4. Chronic lung disease

    Time frame: By 36 weeks corrected gestational age

    Need for oxygen by 36 weeks corrected gestational age

  5. Necrotising enterocolitis

    Time frame: Expected 6 weeks

    Bell clinical and radiological criteria

  6. Intraventricular haemorrhage

    Time frame: Expected 2 weeks

    By cranial ultrasound grading

  7. Periventricular leukomalacia

    Time frame: Expected 8 weeks

    By cranial ultrasound

  8. Retinopathy of prematurity

    Time frame: Expected 8 weeks

    Ophthalmologist using Ret-Cam

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

    Time frame: 6 days after intervention

  10. Adverse effects of Pentoxifylline

    Time frame: Up to 10 days after intervention

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

Sponsors and collaborators

Lead sponsor

Abd Elazeez Attala Shabaan

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2014
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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