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Completed

NCT Number: NCT04772222

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

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Intermountain Medical Center, Murray, Utah, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

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

Morphine sulfate

Drug

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

Primary outcomes

  1. Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine

    Time frame: First 96 hours of life

    Safety will be evaluated during the first 4 days of life by comparing number of serious adverse events between two study arms.

Secondary outcomes

  1. DMT Plasma Levels

    Time frame: one week

    Two opportunistic PK samples (at time of routine laboratories) and a PK sample any time there is an adverse event will be obtained for measurement of DMT plasma concentrations as needed. Because these PK samples are done opportunistically, there are no pre-set defined time points for PK measurements.

Other outcomes

  1. Number of Participants Who Experience Shivering

    Time frame: First 96 hours of life

    Number of babies who experience shivering during therapeutic hypothermia will be compared between the two drug treatment regimens

  2. Number of Days Intubated

    Time frame: First week of life

    Number of days each subject required invasive ventilator support will be compared between arms.

  3. Days to Full Oral Feedings by Bottle or Breast

    Time frame: Up to two months

    Days to full oral feedings will be compared between the two drug treatment regimens

  4. Generalized Motor Assessment Scores at 3-4 Months of Age

    Time frame: 3-4 months of age

    the GMA is a validated test that aids in early detection of neurological movement disorders by evaluating the quality of movements during a 2-minute video. Certified assessors will grade the quality of movements which include: normal writhing, poor repertoire, cramped synchronized, and chaotic movements. All movements other than normal writhing are considered atypical. The results will be compared between the two drug treatments.

  5. Hammersmith Infant Neurological Exam (HINE) Scores at 3-4 Months of Age

    Time frame: 3-4 months of age

    The HINE is a 26 item exam that assesses different aspects of neurological function and these scores will be compared between the two drug treatment regimens. This assessment scores 5 different neurological development areas: Cranial nerve function, posture, movements, tone, and reflexes/reactions. The maximum score is 78 and lowest score is 0. Higher scores show better neurological development consistent with better outcomes.

  6. Hammersmith Infant Neurological Exam (HINE) Scores at 6-9 Months of Age

    Time frame: 6-9 months of age

    The HINE is a 26 item exam that assesses different aspects of neurological function and these scores will be compared between the two drug treatment regimens. This assessment scores 5 different neurological development areas: Cranial nerve function, posture, movements, tone, and reflexes/reactions. The maximum score is 78 and lowest score is 0. Higher scores show better neurological development consistent with better outcomes.

  7. Test of Infant Motor Performance (TIMP) Scores at 3-4 Months of Corrected Age

    Time frame: 3-4 months of corrected age

    This test evaluates posture and motor control and is designed to be used specifically in infants born prematurely. Results are given based on z-scores from normative values and are given as low average, below average, and far below average. Lower scores are more predictive of worse outcomes. These scores will be compared between the two drug treatment regimens.

  8. Peabody Developmental Motor Skills (PDMS-2) at 6-9 Months of Age

    Time frame: 6-9 months of age

    This test evaluates fine motor, gross motor, and total motor skills. Results are converted to age equivalent rating and then quotient scores are given for each category. Minimum is 35 and maximum is 165. The average score is 90-110, with higher scores given in 3 SD above average performance and lower scores given in 3 SD below average performance.The higher the score, the better predicted outcome. These scores will be compared between the two drug treatment regimens.

  9. Ages and Stages Questionnaire at 6-9 Months of Age

    Time frame: 6-9 months of age

    Parental survey that assesses communication, gross and fine motor skills, and social behaviors. Scores range from 0-60, and the higher the score, the better the outcome.

    These scores will be compared between the two drug treatment regimens

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: DICE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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