Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
- Registration Number
- NCT02954926
- Lead Sponsor
- Hormozgan University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVIG IVIG IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
- Primary Outcome Measures
Name Time Method Mortality 7 days Death from sepsis or its related complications
- Secondary Outcome Measures
Name Time Method Total number of days of hospitalization 7 days Duration of hospitalization
Intraventricular Hemorrhage 7 days occurrence of Intraventricular Hemorrhage
Necrotizing enterocolitis 7 days occurrence of Necrotizing enterocolitis
Bronchopulmonary dysplasia 7 days occurrence of Bronchopulmonary dysplasia
Trial Locations
- Locations (1)
Shahid Mohammadi hospital
🇮🇷Bandar Abbas, Hormozgan, Iran, Islamic Republic of