Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Hormozgan University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Neonatal Sepsis

Treatments: Drug: IVIG

Study type: Interventional

Funder types: Other

Identifiers

NCT02954926

HUMS.REC.1394.162

Details and patient eligibility

About

Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.

Enrollment: 92 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born alive before 37 weeks of pregnancy (preterm neonates)
• Under 2500 g at birth

Exclusion criteria

• lethal anomaly
• congenital heart disease
• TORCH infection
• severe asphyxia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

IVIG

Experimental group

Description:

IVIG at a dose of 500mg/kg within 12 h and 3 days of birth

Treatment:

Drug: IVIG

Control

No Intervention group

Description:

No intervention