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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 4

Conditions: Sepsis of the Newborn

Treatments: Drug: Pentoxifylline, pentaglobin

Study type: Interventional

Funder types: Other

Identifiers

NCT01006499

1-akdag

Details and patient eligibility

About

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

Enrollment: 204 estimated patients

Sex: All

Ages: 1 to 90 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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204 participants in 4 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Pentoxifylline, pentaglobin

Pentoxifylline group

Active Comparator group

Description:

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

Treatment:

Drug: Pentoxifylline, pentaglobin

Pentaglobin group

Active Comparator group

Description:

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

Treatment:

Drug: Pentoxifylline, pentaglobin

Pentoxifylline plus Pentaglobin group

Active Comparator group

Description:

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

Treatment:

Drug: Pentoxifylline, pentaglobin