Conditions: Sedation
Keywords: Initially intubated and mechanically ventilated neonates
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).

Detailed description:

Arms:
arm 1: Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. arm 2: Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. arm 3: Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Interventions: intervention 1: Midazolam intervention 2: Fentanyl/Morphine intervention 3: Dexmedetomidine
Intervention descriptions: intervention 1: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion intervention 2: Per package insert, N-PASS scores and investigator discretion. intervention 3: None

Protocol document: