NCT04772222.

Study name	Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Methods	Randomized controlled trial
Participants	50 infants ≥ 36 weeks' gestational age treated with therapeutic hypothermia
Interventions	Dexmedetomidine (loading dose of 1 mcg/kg followed by 0.1 to 0.5 mcg/kg/h as continuous infusion) or morphine (intermittent dosing every 3 to 4 hours of 0.02 to 0.05 mg/kg/dose or continuous infusion of 0.005 to 0.01 mg/kg/h).
Outcomes	Primary outcome: safety measures (adverse events during the first 4 days of life). Secondary outcomes: plasma levels of dexmedetomidine. Other outcomes: Number of participants who experience shivering, number of participants who require respiratory support, days to full oral feedings, generalized motor assessment scores 7 days after weaned of study drug, generalized motor assessment scores at 3 to 4 months of age, Hammersmith infant neurological exam scores at 6 to 9 months of age, test of motor performance scores at 3 to 4 months of corrected age, Peabody Developmental Motor Skills at 6 to 9 months of age, ages and stages questionnaire at 6 to 9 months of age.
Starting date	1 August 2021
Contact information	Mariana Baserga, MD: mariana.baserga@hsc.utah.edu Carrie Rau, RN: carrie.rau@hsc.utah.edu
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