Overview

This trial is active, not recruiting.

Condition sepsis of the newborn
Treatment pentoxifylline, pentaglobin
Phase phase 4
Sponsor Zekai Tahir Burak Women's Health Research and Education Hospital
Start date August 2009
End date October 2010
Trial size 204 participants
Trial identifier NCT01006499, 1-akdag

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).
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)
Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.
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)
Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days
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)
Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.
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

Primary Outcomes

Measure
patient characteristics all cause mortality
time frame: two years

Secondary Outcomes

Measure
Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels
time frame: two years
Effect the production of pro-inflammatory bio-markers.
time frame: two years

Eligibility Criteria

Male or female participants up to 90 days old.

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

Additional Information

Official title Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Zekai Tahir Burak Women's Health Research and Education Hospital.