Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human
immune globulin intravenous (IGIV), can prevent an infection in the blood caused by
staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.
Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or
placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study
Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.