Full Title: Phase II, Open-Label, Multicenter, Escalating Dose, Study to Determine Pharmacokineticand Pharmacodynamic Profile of Dexmedetomidine in Neonates Ages ≥ 28 Weeks to ≤ 44 Weeks Post Gestational Age
PI: Constantinos Chrysostomou, MD
Funding: Hospira, Inc. Lake Forest, Illinois, U.S.A
Purpose of Study
Characterize the loading and maintenance dosing of dexmedetomidine in premature and full term neonates.
Evaluate the safety and efficacy of loading and maintenance infusions for sedation in neonatal ICU patients
Explore the exposure-response relationship between doses of dexmedetomidine and clinical measures of sedation and safety
A Phase II, Open-Label, Multicenter, Escalating Dose of dexmedetomdine