Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Status:
Not yet recruiting
Trial end date:
2024-08-31
Target enrollment:
Participant gender:
Summary
Management of neonatal pain and sedation often includes opioid therapy. A growing body of
evidence suggests long-term harm associated with neonatal opioid exposure. Providing optimal
sedation while neonates are undergoing therapeutic hypothermia (TH) may be beneficial but
also presents therapeutic challenges. While there is evidence from animal models of brain
injury and clinical trials in adults to support the safety and neuroprotective properties of
dexmedetomidine (DMT), there are no published large clinical trials demonstrating safety and
efficacy of DMT use in neonates with hypoxic-ischemic encephalopathy (HIE) during treatment
with TH. This study is innovative in proposing a Phase II, 2-arm trial providing the
opportunity to evaluate the use of DMT as compared to the use of morphine for sedation and
pain management for babies undergoing TH. We propose to confirm optimal DMT dosing by
collecting opportunistic pharmacokinetics (PK) data and determine safety of DMT in this
population. These data will inform a larger phase III efficacy trial.