Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02954926

Enrollment

Registered

2016-11-04

Start date

2015-11-30

Completion date

2016-11-30

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis

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.

Interventions

DRUGIVIG

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 7 Days

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	7 days	Death from sepsis or its related complications

Secondary

Measure	Time frame	Description
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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026