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'

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006499

Enrollment

204

Registered

2009-11-02

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2011-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis of the Newborn

Keywords

neonatal sepsis, pentoxyfilline, pentaglobin, biomarker, To reduce mortality in neonatal sepsis

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.

Interventions

DRUGPentoxifylline, 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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 90 Days

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026