Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Neonatal Sepsis Clinical Trial

Official title:

Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954926
• Other study ID #: HUMS.REC.1394.162
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2016
• Last updated: November 2, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Mohammadi hospital	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death from sepsis or its related complications	7 days	No
Secondary	Total number of days of hospitalization	Duration of hospitalization	7 days	No
Secondary	Intraventricular Hemorrhage	occurrence of Intraventricular Hemorrhage	7 days	No
Secondary	Necrotizing enterocolitis	occurrence of Necrotizing enterocolitis	7 days	No
Secondary	Bronchopulmonary dysplasia	occurrence of Bronchopulmonary dysplasia	7 days	No