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

NCT01006499 | Unknown Phase 4 DMC

• 1 other identifier: 1-akdag
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis of the Newborn

Keywords

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

Outcome Measures

Primary Outcomes (1)

• patient characteristics all cause mortality

  Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis

  two years

Secondary Outcomes (2)

• Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels

  two years

• Effect the production of pro-inflammatory bio-markers.

  two years

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).

Drug: Pentoxifylline, pentaglobin

Pentoxifylline group

ACTIVE COMPARATOR

Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.

Drug: Pentoxifylline, pentaglobin

Pentaglobin group

ACTIVE COMPARATOR

Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days

Drug: Pentoxifylline, pentaglobin

Pentoxifylline plus Pentaglobin group

ACTIVE COMPARATOR

Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.

Drug: Pentoxifylline, pentaglobin

Interventions

Pentoxifylline, pentaglobin DRUG

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

Pentaglobin group; Pentoxifylline group; Pentoxifylline plus Pentaglobin group; Placebo group

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All infants thought/diagnosed to have late or early onset sepsis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak

Ankara, 06120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Pentoxifylline; pentaglobulin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 2, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 11, 2011

Record last verified: 2011-03

Locations

TU (1)