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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates

NCT06985290

Hypoxic Ischemic Brain Injury Neonatal Encephalopathy Perinatal Anoxic-ischemic Brain Injury

NOT_YET_RECRUITING PHASE2

Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care

NCT06482775

Intensive Care, Neonatal Analgesia Hypnotics and Sedatives

WITHDRAWN

Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization

NCT06635174

Pain Management Neonatal Pain

ENROLLING_BY_INVITATION NA

Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates

NCT00286143

Congenital Cystic Adenomatoid Malformation

COMPLETED PHASE3

Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.

NCT01094522

Pain

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxic-Ischemic Encephalopathy Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Infants randomized to receive open-label dexmedetomidine (DMT) or morphine for pain and sedation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexmedetomidine (DMT)

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 Type EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type DRUG

Potent α2-adrenergic receptor agonist that provides sedation, analgesia, and prevents shivering but does not suppress ventilation.

Morphine

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.

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

Opioid agonist that provides analgesia, pain management and sedation and may suppress ventilation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine Hydrochloride

Potent α2-adrenergic receptor agonist that provides sedation, analgesia, and prevents shivering but does not suppress ventilation.

Intervention Type DRUG

Morphine Sulfate

Opioid agonist that provides analgesia, pain management and sedation and may suppress ventilation.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No