drugset / Trial / NCT01203345

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

NCT01203345

Phase 2/3 Completed 2416 enrolled NICHD Neonatal Research Network
RandomizedParallel-groupQuadruple-blindPrevention

Summary

A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group. There were two phases to the study (see below). During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.

Timeline

Start
1988-01
Primary completion
1991-03
Completion
1991-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 700 mg/kg Intravenous
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 900 mg/kg Intravenous