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

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ClinicalTrials.gov Identifier: NCT01006499
Recruitment Status : Unknown
Verified March 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2009
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

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

Condition or disease Intervention/treatment Phase
Sepsis of the Newborn Drug: Pentoxifylline, pentaglobin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
Study Start Date : August 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. patient characteristics all cause mortality [ Time Frame: two years ]
    Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01006499


Locations
Turkey
Zekai Tahir Burak
Ankara, Turkey, 06120
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital

Responsible Party: Arzu Akdağ, ZTB
ClinicalTrials.gov Identifier: NCT01006499     History of Changes
Other Study ID Numbers: 1-akdag
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: March 2011

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
neonatal sepsis
pentoxyfilline
pentaglobin
biomarker
To reduce mortality in neonatal sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Pentoxifylline
Immunologic Factors
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Vasodilator Agents
Free Radical Scavengers
Antioxidants