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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Zekai Tahir Burak Maternity and Teaching Hospital

ClinicalTrials.gov Identifier:

NCT01006499

First received: November 1, 2009

Last updated: March 10, 2011

Last verified: March 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Sepsis of the Newborn	Drug: Pentoxifylline, pentaglobin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Pentoxifylline Rho(D) Immune Globulin

U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:

patient characteristics all cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]
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 [ Time Frame: two years ] [ Designated as safety issue: No ]
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. [ Time Frame: two years ] [ Designated as safety issue: No ]
Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers

Estimated Enrollment:	204
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	up to 90 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006499

Locations

Turkey
Zekai Tahir Burak
Ankara, Turkey, 06120

Sponsors and Collaborators

Zekai Tahir Burak Maternity and Teaching Hospital

More Information

No publications provided

Responsible Party:	Arzu Akdağ, ZTB
ClinicalTrials.gov Identifier:	NCT01006499 History of Changes
Other Study ID Numbers:	1-akdag
Study First Received:	November 1, 2009
Last Updated:	March 10, 2011
Health Authority:	Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:

neonatal sepsis
pentoxyfilline
pentaglobin
biomarker
To reduce mortality in neonatal sepsis

Additional relevant MeSH terms:

Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Pentoxifylline
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on June 18, 2013

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