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
Sponsored by: Zekai Tahir Burak Maternity and Teaching Hospital
The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG
or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.
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
Minimum age: N/A.
Maximum age: 90 Days.
- All infants thought/diagnosed to have late or early onset sepsis.
- 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: firstname.lastname@example.org
Arzu Akdag, Principal Investigator
Starting date: August 2009
Last updated: June 24, 2010