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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours). |
|
| Pentoxifylline group | Active Comparator | Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days. |
|
| Pentaglobin group | Active Comparator | Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days |
|
| Pentoxifylline plus Pentaglobin group | Active Comparator | Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline, pentaglobin | Drug | 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 |
| 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 |
| 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. |
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Inclusion Criteria::
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak | Ankara | 06120 | Turkey (Türkiye) |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2013 | |
| Unrelease | Yes | |
| Release | Aug 25, 2013 | |
| Reset | Oct 30, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2013 | Yes | |||
| Aug 25, 2013 |
| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| C060166 | pentaglobulin |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers |
| two years |
| Oct 30, 2013 |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |