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Phase II, Open-Label, Multicenter, Escalating Dose, Study to Determine Pharmacokinetic...

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

Study Design

A Phase II, Open-Label, Multicenter, Escalating Dose of dexmedetomdine