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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

Tracking Information
First Submitted Date  ICMJE June 6, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date June 16, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Neonatal mortality [ Time Frame: Expected 10 weeks postnatal age ]
Mortality before discharge from neonatal intensive care unit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Length of hospital stay [ Time Frame: Expected average of 8 weeks post natal age ]
    Duration of hospital admission (days)
  • 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)
  • Duration of antibiotics use [ Time Frame: Expected 3 to 5 weeks postnatal age ]
    Duration of treatment of sepsis including meningitis
  • Chronic lung disease [ Time Frame: By 36 weeks corrected gestational age ]
    Need for oxygen by 36 weeks corrected gestational age
  • Necrotising enterocolitis [ Time Frame: Expected 6 weeks ]
    Bell clinical and radiological criteria
  • Intraventricular haemorrhage [ Time Frame: Expected 2 weeks ]
    By cranial ultrasound grading
  • Periventricular leukomalacia [ Time Frame: Expected 8 weeks ]
    By cranial ultrasound
  • Retinopathy of prematurity [ Time Frame: Expected 8 weeks ]
    Ophthalmologist using Ret-Cam
  • Serum levels of Tumor necrosis factor-α, C-Reactive protein [ Time Frame: 6 days after intervention ]
  • Adverse effects of Pentoxifylline [ Time Frame: Up to 10 days after intervention ]
    Adverse effects of Pentoxifylline such as feeding intolerance, thrombocytopenia and cholestasis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pentoxifylline and Late Onset Sepsis in Preterm Infants
Official Title  ICMJE Pentoxifylline Therapy of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neonatal Late Onset Sepsis
Intervention  ICMJE
  • 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)
  • 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.
Study Arms  ICMJE
  • Active Comparator: Pentoxyfilline arm
    Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics.
    Intervention: 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.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2014)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163174
Other Study ID Numbers  ICMJE 12345
R88 ( Other Identifier: local institutional research board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abd Elazeez Attala Shabaan, Mansoura University
Study Sponsor  ICMJE Abd Elazeez Attala Shabaan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abd Elazeez AT Shabaan, PhD Mansoura University, Faculty of Medicine
PRS Account Mansoura University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP