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Alpha-2 Agonist

Dexmedetomidine for Neonatal Encephalopathy (DICE Trial)

Phase 2
Recruiting
Led By Mariana Baserga, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-9 months of age
Awards & highlights

DICE Trial Summary

This trial is testing whether using dexmedetomidine (DMT) is safer and more effective than using morphine for sedation and pain management for babies undergoing therapeutic hypothermia (TH).

Who is the study for?
This trial is for newborns at least 36 weeks old with moderate-to-severe brain injury from lack of oxygen and undergoing cooling therapy. They need sedation or shiver prevention, as judged by specific pain and shivering scales. Babies with genetic anomalies, critical conditions leading to care redirection, or certain heart defects cannot join.Check my eligibility
What is being tested?
The DICE Trial is testing the safety and dosing of Dexmedetomidine (DMT) compared to Morphine for managing pain and sedation in infants receiving therapeutic hypothermia for brain injuries due to oxygen deprivation. It's a Phase II study that will set the stage for a larger efficacy trial.See study design
What are the potential side effects?
Dexmedetomidine may cause low blood pressure, slow heart rate, dry mouth, nausea; while Morphine can lead to respiratory depression, constipation, drowsiness, vomiting. The exact side effects in newborns are being studied.

DICE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My newborn, at least 36 weeks old, has severe brain dysfunction and is undergoing cooling treatment.
Select...
My infant needs medication to stay calm or stop shivering during treatment.

DICE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Examine Safety Measures in infants receiving DMT to those receiving morphine
Secondary outcome measures
DMT plasma levels
Other outcome measures
Ages and Stages Questionnaire at 6-9 months of age
Days to full oral feedings by bottle or breast
Generalized Motor Assessment Scores (GMA) 7 days after weaned off of study drug or discharge, whichever happens first
+7 more

Side effects data

From 2015 Phase 4 trial • 60 Patients • NCT03078946
3%
Delirium
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dexmedetomidine Group (N=30)
Morphine With Midazolam (N=30)

DICE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dexmedetomidine (DMT)Experimental Treatment1 Intervention
Subjects randomized to DMT arm in a 1:1 ratio. A loading dose of 1 mcg/kg will be given followed by 0.1 to 0.5 mcg/kg/h continuous infusion. The Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be used to determine infusion rate.
Group II: MorphineActive Control1 Intervention
Subjects randomized to morphine in a 1:1 ratio. Intermittent dosing every 3-4 hours of 0.02-0.05 mg/kg/dose or continuous infusion of 0.005 to 0.01 mg/kg/hr. The N-PASS will be used to determine dosing and frequency.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine Hydrochloride
2013
Completed Phase 4
~940

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,672 Total Patients Enrolled
Mariana Baserga, MDPrincipal InvestigatorUniversity of Utah
4 Previous Clinical Trials
158 Total Patients Enrolled

Media Library

Dexmedetomidine Hydrochloride (Alpha-2 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04772222 — Phase 2
Hypoxic-Ischemic Encephalopathy Research Study Groups: Morphine, Dexmedetomidine (DMT)
Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Dexmedetomidine Hydrochloride Highlights & Side Effects. Trial Name: NCT04772222 — Phase 2
Dexmedetomidine Hydrochloride (Alpha-2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04772222 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can potentially be included in this clinical research endeavor?

"Affirmative. Clinicaltrials.gov states that this medical study, which went live on June 20th 2022, is currently enrolling participants. 50 individuals must be recruited from 5 different clinical settings to complete the trial's requirements."

Answered by AI

Are there any open slots available for participants in this research endeavor?

"This medical trial, which was initially advertised on June 20th 2022, is currently accepting applications. As of November 1st 2022 the listing has been updated with new information."

Answered by AI

How many venues are currently hosting this clinical experiment?

"Currently, this trial is seeking patients from McKay-Dee Hospital in Ogden, Primary Children's Hospital in Salt Lake City and University of Utah Health in Murray. Additionally, there are 5 other medical centres accepting participants for the study."

Answered by AI

Are there any other reports of Dexmedetomidine Hydrochloride being used in controlled studies?

"At present, there are 159 Dexmedetomidine Hydrochloride clinical trials in progress. Out of these experiments, 37 have reached Phase 3 status. In addition to a concentration in Boston, Massachusetts, 327 different medical centres across the nation are researching this pharmaceutical solution."

Answered by AI

What health issues does Dexmedetomidine Hydrochloride typically help to address?

"Dexmedetomidine Hydrochloride is commonly used to reduce pain, but can also be employed for anesthesia and disease management or therapeutic procedures."

Answered by AI

Has Dexmedetomidine Hydrochloride been given the green light from regulatory authorities?

"The safety of Dexmedetomidine Hydrochloride warrants a score of 2 since there is existing data suggesting it's safe, but not enough evidence to support its efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Utah Valley Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need the help.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Mariana Baserga 2022. "Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04772222.
All > Pain Management > Pain
~9 spots leftby Sep 2024
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