Status:
ACTIVE_NOT_RECRUITING
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Lead Sponsor:
University of Utah
Conditions:
Hypoxic-Ischemic Encephalopathy
Pain
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief 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 ne...
Eligibility Criteria
Inclusion
- 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
- Known chromosomal anomalies
- Cyanotic congenital heart defects
- Redirection of care being considered because of moribund condition, or a decision made to withhold full support
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04772222
Start Date
June 20 2022
End Date
December 31 2025
Last Update
April 11 2025
Active Locations (5)
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1
Intermountain Medical Center
Murray, Utah, United States, 84107
2
McKay-Dee Hospital
Ogden, Utah, United States, 84403
3
Utah Valley Hospital
Provo, Utah, United States, 84604
4
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113