Role of ‘Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis’

Overview

The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.

Full Title of Study: “Phase 4 Study of Role of ‘Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2010

Interventions

  • Drug: Pentoxifylline, pentaglobin
    • Pentaglobin 250mg/kg/d over 4 hour for three days Pentoxyfilline 6mg/kg/h over 4 hour for three days Pentaglobin 250mg/kg/d over 4 hour for three days+Pentoxyfilline 6mg/kg/h over 4 hour for three days Placebo (normal saline 5ml/kg over 4 hour for three days

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo group
    • Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).
  • Active Comparator: Pentoxifylline group
    • Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.
  • Active Comparator: Pentaglobin group
    • Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days
  • Active Comparator: Pentoxifylline plus Pentaglobin group
    • Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.

Clinical Trial Outcome Measures

Primary Measures

  • patient characteristics all cause mortality
    • Time Frame: two years
    • Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis

Secondary Measures

  • Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels
    • Time Frame: two years
    • Assess the effectiveness of Pentoxifylline or Pentoxifylline plus IgM enriched IVIG in reducing neuro-developmental morbidity secondary to sepsis at the age of 18 months
  • Effect the production of pro-inflammatory bio-markers.
    • Time Frame: two years
    • Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers

Participating in This Clinical Trial

Inclusion Criteria

:

  • All infants thought/diagnosed to have late or early onset sepsis. Exclusion Criteria:

  • Pentoxifylline or Pentaglobin has already been given – Pentoxifylline or Pentaglobin is thought to be needed or contra-indicated – Major congenital anomaly – Intraventricular hemorrhage (Grade 3 veya 4) – Congenital infections – Inborn errors of metabolism

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 90 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zekai Tahir Burak Women’s Health Research and Education Hospital
  • Provider of Information About this Clinical Study
    • Arzu Akda─č, ZTB

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