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

Completed · Phase 2

Conditions studied: Hypoxic-Ischemic Encephalopathy, Pain

In brief

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.

Key facts

Study ID

NCT04772222

Run by

University of Utah

People needed

50

Starts

2022-06-20

Expected to finish

2025-12-31

Last updated by the study team

2026-03-06

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates ≥36 weeks' gestational age diagnosed with moderate-to-severe neonatal encephalopathy and treated with TH (target temperature 33.5°C) for a planned duration of 72 h.
• Infants requiring sedation and/or treatment to prevent shivering during TH as assessed by the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores and a modified Bedside Shivering Assessment Scale.
• Informed consent document approved by the Institutional Review Board (IRB) obtained prior to randomization

You may not qualify if…

• Known chromosomal anomalies
• Cyanotic congenital heart defects
• Redirection of care being considered because of moribund condition, or a decision made to withhold full support

Where it is running

• Intermountain Medical Center — Murray, Utah, United States
• McKay-Dee Hospital — Ogden, Utah, United States
• Utah Valley Hospital — Provo, Utah, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• University of Utah Health — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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