NCT04772222

Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Pain

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Hydrochloride	Potent α2-adrenergic receptor agonist that provides sedation, analgesia, and prevents shivering but does not suppress ventilation.
DRUG	Morphine Sulfate	Opioid agonist that provides analgesia, pain management and sedation and may suppress ventilation.

Timeline

• Start date: 2022-06-20
• Primary completion: 2025-01-17
• Completion: 2025-12-31
• First posted: 2021-02-26
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study