Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
NCT ID: NCT01006499
Last Updated: 2011-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
204 participants
INTERVENTIONAL
2009-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Placebo group
Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).
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
Pentoxifylline group
Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.
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
Pentaglobin group
Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Day
90 Days
ALL
No
Sponsors
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Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
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ZTB
Locations
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Zekai Tahir Burak
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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1-akdag
Identifier Type: -
Identifier Source: org_study_id
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