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

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

Official Title
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Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'

Conditions
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Sepsis of the Newborn

Intervention / Treatment
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* Drug: Pentoxifylline, pentaglobin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours). | Drug: Pentoxifylline, pentaglobin<br>* 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<br>|
| Active Comparator: Pentoxifylline group<br>Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days. | Drug: Pentoxifylline, pentaglobin<br>* 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<br>|
| Active Comparator: Pentaglobin group<br>Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days | Drug: Pentoxifylline, pentaglobin<br>* 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<br>|
| Active Comparator: Pentoxifylline plus Pentaglobin group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient characteristics all cause mortality | Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels | 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 | two years | 
| Effect the production of pro-inflammatory bio-markers. | Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal sepsis, pentoxyfilline, pentaglobin, biomarker, To reduce mortality in neonatal sepsis