# Dexmedetomidine Use in Infants undergoing Cooling due to Neonatal Encephalopathy (DICE trial)

> **NIH NIH R21** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2022 · $243,917

## Abstract

PROJECT SUMMARY
Dexmedetomidine Use in Infants undergoing Cooling due to Neonatal Encephalopathy (DICE trial)
Hypoxia-ischemia encephalopathy (HIE, commonly called “birth asphyxia”) is a condition where the brain
doesn’t get enough oxygen. HIE affects 2 out of every 1,000 babies. Despite early intervention using brain
cooling, outcomes of death or major disability, such as cerebral palsy and mental retardation, still occurs in
nearly 30% of these babies. No other therapies have been proven to further reduce brain injury for these high
risk infants. Furthermore, additional brain injury may be caused by concomitant use of drugs such as morphine
to treat pain and sedation in this population. Morphine use in animal models can increase neuronal apoptosis
and negatively affect neurodevelopment. Developing adjunctive therapies that improve outcomes in infants
with HIE is an urgent, unmet public health need.
Dexmedetomidine is a potent α2-adrenergic receptor agonist that may be a better alternative to morphine for
newborns with neonatal HIE treated with cooling. Dexmedetomidine provides sedation, analgesia, and
prevents shivering but does not suppress breathing. Importantly, dexmedetomidine has been shown to protect
the brain in animal models of brain injury. Recent clinical studies also suggest improved brain outcomes after
dexmedetomidine administration in adult patients with brain injury. Even though there are limited data on
dexmedetomidine safety and usefulness as well as pharmacokinetics (PK; drug levels in blood) in infants with
HIE it has been increasingly administered in many centers.
Our central hypothesis is that dexmedetomidine administered for sedation to full-term infants with HIE
undergoing cooling will be safe (AIM 1) and will be associated with improved short and long-term outcomes
(AIM 3). To test this hypothesis, we have designed a Phase II multicenter, randomized, safety and PK trial.
Fifty infants (n=25 in each arm) with HIE and requiring sedation will be randomized to receive either
dexmedetomidine (1 μg/kg for loading dose followed by 0.1 to 0.5 μg/kg/h continuous infusion) or morphine
(0.02-0.03 mg/kg/dose intermittent dosing q 4 hours IV or as continuous infusion dose of 0.005- 0.01
mg/kg/hr). Two opportunistic PK samples (at time of routine laboratories) and a PRN PK sample any time there
is an adverse event will be obtained for measurement of Dexmedetomidine plasma concentrations (AIM 2).
Promising preliminary data show that dexmedetomidine may improve outcomes but optimal dosing, safety, and
efficacy still need to be established. We propose to confirm dexmedetomidine optimal dosing by collecting
opportunistic blood samples for PK data and determine safety of dexmedetomidine in this population in a
phase II safety trial. These data will inform a larger phase III trial to assess the efficacy of this therapy in
reducing the risk of long-term disabilities in infants with HIE who survive beyond the newborn period.

## Key facts

- **NIH application ID:** 10390861
- **Project number:** 1R21HD107754-01
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Mariana Baserga
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $243,917
- **Award type:** 1
- **Project period:** 2022-02-14 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10390861

## Citation

> US National Institutes of Health, RePORTER application 10390861, Dexmedetomidine Use in Infants undergoing Cooling due to Neonatal Encephalopathy (DICE trial) (1R21HD107754-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10390861. Licensed CC0.

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