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

Information source: Zekai Tahir Burak Maternity and Teaching Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Sepsis

Intervention: Pentoxifylline, pentaglobin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Zekai Tahir Burak Maternity and Teaching Hospital

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: patient characteristics all cause mortality

Secondary outcome: Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels

Eligibility

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

Criteria:

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 and Contacts

Zekai Tahir Burak, Ankara 06120, Turkey; Recruiting
Arzu Akdag, Phone: 003123065270, Ext: 5270, Email: arzuakdag@hotmail.com
Arzu Akdag, Principal Investigator
Additional Information

Starting date: August 2009
Last updated: June 24, 2010

Page last updated: October 04, 2010

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