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

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

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

Study Overview

• Status: Unknown
• Conditions: Sepsis of the Newborn
• Intervention / Treatment: Drug: Pentoxifylline, pentaglobin

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06120
    • Zekai Tahir Burak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): October 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: November 1, 2009
• First Submitted That Met QC Criteria: November 1, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Estimate): March 11, 2011
• Last Update Submitted That Met QC Criteria: March 10, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: biomarker; neonatal sepsis; pentoxyfilline; pentaglobin; To reduce mortality in neonatal sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: 1-akdag