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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

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

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

NCT ID

NCT01006499

First Posted

November 1, 2009

Last Updated

March 10, 2011

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

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

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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