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

Phase 4

• Conditions: Sepsis of the Newborn
• Interventions: Drug: Pentoxifylline, pentaglobin

• Registration Number: NCT01006499
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-01
• Study First Submitted QC: 2009-11-01
• Study First Posted: 2009-11-01
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-10
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Pentaglobin group	Pentoxifylline, pentaglobin	Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days
Pentoxifylline plus Pentaglobin group	Pentoxifylline, pentaglobin	Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.
Placebo group	Pentoxifylline, pentaglobin	Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).
Pentoxifylline group	Pentoxifylline, pentaglobin	Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.

Primary Outcome Measures

Name	Time	Method
patient characteristics all cause mortality	two years	Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels	two years	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.	two years	Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers

Trial Locations

Locations (1)

Zekai Tahir Burak; 🇹🇷 Ankara, Turkey