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

Primary Purpose

Sepsis of the Newborn

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Pentoxifylline, pentaglobin
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis of the Newborn focused on measuring neonatal sepsis, pentoxyfilline, pentaglobin, biomarker, To reduce mortality in neonatal sepsis

Eligibility Criteria

1 Day - 90 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zekai Tahir Burak

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo group

Pentoxifylline group

Pentaglobin group

Pentoxifylline plus Pentaglobin group

Arm Description

Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).

Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.

Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days

Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.

Outcomes

Primary Outcome Measures

patient characteristics all cause mortality
Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis

Secondary Outcome Measures

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
Effect the production of pro-inflammatory bio-markers.
Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers

Full Information

First Posted
November 1, 2009
Last Updated
March 10, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01006499
Brief Title
Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
Official Title
Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis of the Newborn
Keywords
neonatal sepsis, pentoxyfilline, pentaglobin, biomarker, To reduce mortality in neonatal sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).
Arm Title
Pentoxifylline group
Arm Type
Active Comparator
Arm Description
Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.
Arm Title
Pentaglobin group
Arm Type
Active Comparator
Arm Description
Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days
Arm Title
Pentoxifylline plus Pentaglobin group
Arm Type
Active Comparator
Arm Description
Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline, pentaglobin
Intervention Description
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 Measure Information:
Title
patient characteristics all cause mortality
Description
Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis
Time Frame
two years
Secondary Outcome Measure Information:
Title
Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels
Description
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
Time Frame
two years
Title
Effect the production of pro-inflammatory bio-markers.
Description
Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Zekai Tahir Burak
City
Ankara
ZIP/Postal Code
06120
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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