drugset / Trial / NCT03403530

Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates

NCT03403530

Phase 4 Completed 60 enrolled Sir Takhtasinhji General Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.

Timeline

Start
2018-01-30
Primary completion
2018-06-30
Completion
2018-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pentaglobin Protein / enzyme biologic 5 unknown Intravenous

Indications