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

Condition(s) targeted: Sepsis of the Newborn

Intervention: Pentoxifylline, pentaglobin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Zekai Tahir Burak Women's Health Research and Education 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, 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

Effect the production of pro-inflammatory bio-markers.

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

Zekai Tahir Burak, Ankara 06120, Turkey

Starting date: August 2009
Last updated: March 10, 2011