Trial · NCT04772222
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
NCT04772222, Phase 2, Completed, University of Utah; results first posted 2026-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial). Trials, record NCT04772222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04772222
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
- NCT number
- NCT04772222
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Hypoxic-Ischemic Encephalopathy, Pain
- Interventions
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- First posted
- 2021-02-26
- Last updated
- 2026-03-06
- Results first posted
- 2026-03-06
- Limitations and caveats
A limitation of the DICE trial design was that it was unblinded. This was due to morphine given as an intermittent bolus dose in our NICUs whereas dexmedetomidine can only be given continuous. Another important limitation was the number of protocol deviations, mostly related to N-PASS scores measured at the wrong times or drug dose adjustments not documented. This issue was as frequent in both arms of the trial but could have affected some of the results.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine | 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 | DMT Plasma Levels | 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 | Number of Participants Who Experience Shivering | First 96 hours of life | Number of babies who experience shivering during therapeutic hypothermia will be compared between the two drug treatment regimens |
| Other | Number of Days Intubated | First week of life | Number of days each subject required invasive ventilator support will be compared between arms. |
| Other | Days to Full Oral Feedings by Bottle or Breast | Up to two months | Days to full oral feedings will be compared between the two drug treatment regimens |
| Other | Generalized Motor Assessment Scores at 3-4 Months of Age | 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. |
| Other | Hammersmith Infant Neurological Exam (HINE) Scores at 3-4 Months of Age | 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. |
| Other | Hammersmith Infant Neurological Exam (HINE) Scores at 6-9 Months of Age | 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. |
| Other | Test of Infant Motor Performance (TIMP) Scores at 3-4 Months of Corrected Age | 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. |
| Other | Peabody Developmental Motor Skills (PDMS-2) at 6-9 Months of Age | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine | First 96 hours of life | Number of serious adverse events | NUMBER | |
| SECONDARY | DMT Plasma Levels | one week | Pharmacokinetics were only analyzed in the dexmedetomidine group. | Dexemedetomidine concentration in pg/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants Who Experience Shivering | First 96 hours of life | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Days Intubated | First week of life | Number of days intubated | MEDIAN | |
| OTHER_PRE_SPECIFIED | Days to Full Oral Feedings by Bottle or Breast | Up to two months | Number of days to full feeds | MEDIAN | |
| OTHER_PRE_SPECIFIED | Generalized Motor Assessment Scores at 3-4 Months of Age | 3-4 months of age | |||
| OTHER_PRE_SPECIFIED | Hammersmith Infant Neurological Exam (HINE) Scores at 3-4 Months of Age | 3-4 months of age | |||
| OTHER_PRE_SPECIFIED | Hammersmith Infant Neurological Exam (HINE) Scores at 6-9 Months of Age | 6-9 months of age | |||
| OTHER_PRE_SPECIFIED | Test of Infant Motor Performance (TIMP) Scores at 3-4 Months of Corrected Age | 3-4 months of corrected age | |||
| OTHER_PRE_SPECIFIED | Peabody Developmental Motor Skills (PDMS-2) at 6-9 Months of Age | 6-9 months of age |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine | Dexmedetomidine (DMT) | 1 | Number of serious adverse events | ||
| Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine | Morphine | 1 | Number of serious adverse events | ||
| DMT Plasma Levels | Dexmedetomidine (DMT) | 651 | Full Range 90.5 to 2960 | Dexemedetomidine concentration in pg/mL | |
| Number of Participants Who Experience Shivering | Dexmedetomidine (DMT) | 13 | Participants | ||
| Number of Participants Who Experience Shivering | Morphine | 14 | Participants | ||
| Number of Days Intubated | Dexmedetomidine (DMT) | 2 | Inter-Quartile Range 0 to 4 | Number of days intubated | |
| Number of Days Intubated | Morphine | 1 | Inter-Quartile Range 0 to 5 | Number of days intubated | |
| Days to Full Oral Feedings by Bottle or Breast | Dexmedetomidine (DMT) | 11 | Inter-Quartile Range 5 to 14 | Number of days to full feeds | |
| Days to Full Oral Feedings by Bottle or Breast | Morphine | 7 | Inter-Quartile Range 5 to 9 | Number of days to full feeds |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexmedetomidine (DMT) | 26 | |
| Overall Study | STARTED | Morphine | 24 | |
| Overall Study | COMPLETED | Dexmedetomidine (DMT) | 25 | |
| Overall Study | COMPLETED | Morphine | 23 | |
| Overall Study | NOT COMPLETED | Dexmedetomidine (DMT) | 1 | |
| Overall Study | NOT COMPLETED | Morphine | 1 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bradycardia | Cardiac disorders | Dexmedetomidine (DMT) | 5 | 25 | |
| other | Bradycardia | Cardiac disorders | Morphine | 3 | 23 | |
| other | Tachycardia | Cardiac disorders | Dexmedetomidine (DMT) | 2 | 25 | |
| other | Tachycardia | Cardiac disorders | Morphine | 0 | 23 | |
| other | Hypotension | Cardiac disorders | Dexmedetomidine (DMT) | 8 | 25 | |
| other | Hypotension | Cardiac disorders | Morphine | 3 | 23 | |
| other | Hypertension | Cardiac disorders | Dexmedetomidine (DMT) | 8 | 25 | |
| other | Hypertension | Cardiac disorders | Morphine | 8 | 23 | |
| other | Seizures | Nervous system disorders | Dexmedetomidine (DMT) | 2 | 25 | |
| other | Seizures | Nervous system disorders | Morphine | 0 | 23 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexmedetomidine (DMT) | 0 | 25 |
| Total, all-cause mortality | Morphine | 1 | 23 |
| Total, other adverse events | Dexmedetomidine (DMT) | 16 | 25 |
| Total, other adverse events | Morphine | 8 | 23 |
| Total, serious adverse events | Dexmedetomidine (DMT) | 1 | 25 |
| Total, serious adverse events | Morphine | 1 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexmedetomidine (DMT) vs Morphine: Number of Participants Who Experience Shivering | Trial comparisons |
| Dexmedetomidine (DMT) vs Morphine: deaths from any cause | Trial comparisons |
| Dexmedetomidine (DMT) vs Morphine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04772222
GET https://conductscience.org/api/trials/v1/NCT04772222/registered