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NCT04772222 · ClinicalTrials.gov registry record · Phase 2
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
A Phase 2 study of Pain and Hypoxic Ischemic Encephalopathy, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT04772222: Completed Phase 2 study of Pain and Hypoxic Ischemic Encephalopathy, sponsored by University of Utah.
NCT04772222 is a Phase 2 study of Pain and Hypoxic Ischemic Encephalopathy that has completed, run by University of Utah. The registered enrollment target is 50 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (84% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04772222, a Phase 2 study of Pain and Hypoxic Ischemic Encephalopathy, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Safety will be evaluated during the first 4 days of life by comparing number of serious adverse events between two study arms.
Conditions Studied
Interventions
- DRUG Morphine Sulfate
- DRUG Dexmedetomidine Hydrochloride
Study Locations (5)
Utah
- Intermountain Medical Center - Murray
- McKay-Dee Hospital - Ogden
- Utah Valley Hospital - Provo
- Primary Children's Hospital - Salt Lake City
- University of Utah Health - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the finished NCT04772222 record still lists
NCT04772222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Morphine Sulfate is the first listed.
NCT04772222 lists 5 locations in 1 state (Utah).
Frequently Asked Questions
What is clinical trial NCT04772222 about?
NCT04772222 is a clinical study titled "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 c...
What is the current status of trial NCT04772222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-06-20. Estimated completion is 2025-12-31.
What conditions does trial NCT04772222 study?
This clinical trial studies the following conditions: Pain, Hypoxic Ischemic Encephalopathy.
What interventions are being tested in trial NCT04772222?
The interventions under investigation include: Morphine Sulfate (DRUG), Dexmedetomidine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04772222?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04772222 being conducted?
This trial has 5 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04772222's enrollment target sits among peer trials
50 254th of 374 higher than 111 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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