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'

Sponsors

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

Source Zekai Tahir Burak Women's Health Research and Education Hospital
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.

Overall Status Unknown status
Start Date August 2009
Completion Date December 2010
Primary Completion Date October 2010
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
patient characteristics all cause mortality two years
Secondary Outcome
Measure Time Frame
Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels two years
Effect the production of pro-inflammatory bio-markers. two years
Enrollment 204
Condition
Intervention

Intervention Type: Drug

Intervention Name: Pentoxifylline, pentaglobin

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

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

Gender: All

Minimum Age: N/A

Maximum Age: 90 Days

Healthy Volunteers: No

Location
Facility: Zekai Tahir Burak
Location Countries

Turkey

Verification Date

March 2011

Responsible Party

Name Title: Arzu Akdağ

Organization: ZTB

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Placebo group

Type: Placebo Comparator

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

Label: Pentoxifylline group

Type: Active Comparator

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

Label: Pentaglobin group

Type: Active Comparator

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

Label: Pentoxifylline plus Pentaglobin group

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov