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

Zekai Tahir Burak Women's Health Research and Education Hospital204 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

204

Conditions

Sepsis of the Newborn

Interventions

Pentoxifylline, pentaglobinDRUG

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

Sex: ALLMin age: 1 DayMax age: 90 Days

Medical Language ↔ Plain English

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

Locations (1)

Zekai Tahir Burak

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

patient characteristics all cause mortality

Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis

Time frame: two years

Secondary Outcomes

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

Time frame: two years

Effect the production of pro-inflammatory bio-markers.

Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers

Time frame: two years

Data from ClinicalTrials.gov

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