A Phase 2 interventional study of Dexmedetomidine Hydrochloride and Morphine Sulfate in Hypoxic-Ischemic Encephalopathy and Pain, sponsored by University of Utah. Completed at 5 sites in United States. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by University of Utah · Phase 2, Interventional, and Treatment
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.
234 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 83 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 135 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Dexmedetomidine Hydrochloride
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.
Drug: Morphine Sulfate
Potent α2-adrenergic receptor agonist that provides sedation, analgesia, and prevents shivering but does not suppress ventilation.
Opioid agonist that provides analgesia, pain management and sedation and may suppress ventilation.
Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine
Safety will be evaluated during the first 4 days of life by comparing number of serious adverse events between two study arms.
Time frame: First 96 hours of life
DMT Plasma Levels
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.
Time frame: one week
Number of Participants Who Experience Shivering
Number of babies who experience shivering during therapeutic hypothermia will be compared between the two drug treatment regimens
Time frame: First 96 hours of life
Number of Days Intubated
Number of days each subject required invasive ventilator support will be compared between arms.
Time frame: First week of life
Days to Full Oral Feedings by Bottle or Breast
Days to full oral feedings will be compared between the two drug treatment regimens
Time frame: Up to two months
Generalized Motor Assessment Scores at 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.
Time frame: 3-4 months of age
Hammersmith Infant Neurological Exam (HINE) Scores at 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.
Time frame: 3-4 months of age
Hammersmith Infant Neurological Exam (HINE) Scores at 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.
Time frame: 6-9 months of age
Test of Infant Motor Performance (TIMP) Scores at 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.
Time frame: 3-4 months of corrected age
Peabody Developmental Motor Skills (PDMS-2) at 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.
Time frame: 6-9 months of age
Ages and Stages Questionnaire at 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
Time frame: 6-9 months of age
Enrolled from June 2022 to Jan 2025 and a total of 50 babies were consented to the study. Two babies were withdrawn due to no receipt of study drug, making enrollment of evaluable babies a total of 48.Due to slow enrollment and lack of funding, enrollment of evaluable babies completed at 48 instead of 50.
| Milestone | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| Started | 26 | 24 |
| Completed | 25 | 23 |
| Not completed | 1 | 1 |
| Withdrew: Did not receive study drug | 1 | 1 |
Safety will be evaluated during the first 4 days of life by comparing number of serious adverse events between two study arms.
| Number of serious adverse events | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine | 1 | 1 |
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.
| Dexemedetomidine concentration in pg/mL | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| DMT Plasma Levels | 651 (90.5 to 2960) | — |
Number of babies who experience shivering during therapeutic hypothermia will be compared between the two drug treatment regimens
| Participants | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| Number of Participants Who Experience Shivering | 13 | 14 |
Number of days each subject required invasive ventilator support will be compared between arms.
| Number of days intubated | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| Number of Days Intubated | 2 (0 to 4) | 1 (0 to 5) |
Days to full oral feedings will be compared between the two drug treatment regimens
| Number of days to full feeds | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| Days to Full Oral Feedings by Bottle or Breast | 11 (5 to 14) | 7 (5 to 9) |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Collected over Adverse events were reported that occured from randomization to 96 hours of life (study interventions phase). Serious adverse events were recorded if they occurred from randomization to 7 days post last study drug dose or hospital discharge up to 11 days, whichever occurred first.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine (DMT) | 0/25 (0%) | 1/25 (4%) | 16/25 (64%) |
| Morphine | 1/23 (4.3%) | 1/23 (4.3%) | 8/23 (34.8%) |
| Event | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| Multi-organ failureGeneral disorders | 0/25 | 1/23 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/25 | 0/23 |
| Event | Dexmedetomidine (DMT) | Morphine |
|---|---|---|
| HypertensionCardiac disorders | 8/25 | 8/23 |
| HypotensionCardiac disorders | 8/25 | 3/23 |
| BradycardiaCardiac disorders | 5/25 | 3/23 |
| TachycardiaCardiac disorders | 2/25 | 0/23 |
| SeizuresNervous system disorders | 2/25 | 0/23 |
Babies \>/= to 36 weeks gestation diagnosed with hypoxic-ischemic encephalopathy and receiving therapeutic hypothermia per NICU standard care
| Age, Categorical(Participants) | Dexmedetomidine (DMT) | Morphine | Total |
|---|---|---|---|
| <=18 years | 25 | 23 | 48 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Dexmedetomidine (DMT) | Morphine | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 15 | 12 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Dexmedetomidine (DMT) | Morphine | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 9 | 15 |
| Not Hispanic or Latino | 18 | 14 | 32 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Dexmedetomidine (DMT) | Morphine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 2 | 0 | 2 |
| White | 15 | 18 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Region of Enrollment(participants) | Dexmedetomidine (DMT) | Morphine | Total |
|---|---|---|---|
| United States | 25 | 23 | 48 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Utah