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

Sepsis of the Newborn Clinical Trial

Official title:

Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01006499
• Other study ID #: 1-akdag
• Status: Unknown status
• Phase: Phase 4
• First received: November 1, 2009
• Last updated: March 10, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 204
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Sepsis of the Newborn
• Toxemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak	Ankara

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient characteristics all cause mortality	Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis	two years
Secondary	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	two years
Secondary	Effect the production of pro-inflammatory bio-markers.	Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers	two years