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Pentoxifylline and Late Onset Sepsis in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02163174
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Abd Elazeez Attala Shabaan, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Neonatal Late Onset Sepsis Drug: Pentoxifylline (PTX) Drug: Placebo Phase 3

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
Study Start Date : May 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Active Comparator: Pentoxyfilline arm
Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.
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
Other Name: Trental (brand name)

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
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 Outcome Measures :
  1. Neonatal mortality [ Time Frame: Expected 10 weeks postnatal age ]
    Mortality before discharge from neonatal intensive care unit


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163174


Locations
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Egypt
Mansoura University Children Hospital
Mansoura, Eldakahlia, Egypt, 35516
Sponsors and Collaborators
Abd Elazeez Attala Shabaan
Investigators
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Principal Investigator: Abd Elazeez AT Shabaan, PhD Mansoura University, Faculty of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abd Elazeez Attala Shabaan, Associate Professor of Pediatrics, Mansoura faculty of Medicine, Mansoura University
ClinicalTrials.gov Identifier: NCT02163174     History of Changes
Other Study ID Numbers: 12345
R88 ( Other Identifier: local institutional research board )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by Abd Elazeez Attala Shabaan, Mansoura University:
neonatal
pentoxifylline
randomized controlled trial

Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Pentoxifylline
Anti-Infective Agents
Antitubercular Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants