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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.

Must not have

Known chromosomal anomalies

Cyanotic congenital heart defects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-9 months of age

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My newborn, at least 36 weeks old, has severe brain dysfunction and is undergoing cooling treatment.

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My infant needs medication to stay calm or stop shivering during treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known genetic abnormality.

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I have a heart defect present from birth that causes bluish skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Examine Safety Measures in infants receiving DMT to those receiving morphine

Secondary study objectives

DMT plasma levels

Other study objectives

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

Delirium

100%

80%

60%

40%

20%

Study treatment Arm

Dexmedetomidine Group (N=30)

Morphine With Midazolam (N=30)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1000

0 / 4Eligibility criteria met