Clinical trial NCT04772222: Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Official title: Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hypoxic-Ischemic Encephalopathy
Pain
Keywords: Therapeutic hypothermia
dexmedetomidine
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 50
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants randomized to receive open-label dexmedetomidine (DMT) or morphine for pain and sedation.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Examine Safety Measures in infants receiving DMT to those receiving morphine
timeFrame: First 96 hours of life
Secondary outcomes:
measure: DMT plasma levels
timeFrame: one week
Other outcomes:
measure: Number of participants who experience shivering
timeFrame: First 96 hours of life
measure: Number of participants who require respiratory support
timeFrame: First week of life
measure: Days to full oral feedings by bottle or breast
timeFrame: Up to two months
measure: Generalized Motor Assessment Scores (GMA) 7 days after weaned off of study drug or discharge, whichever happens first
timeFrame: up to 3 weeks
measure: Generalized Motor Assessment Scores at 3-4 months of age
timeFrame: 3-4 months of age
measure: Hammersmith Infant Neurological Exam (HINE) scores at 3-4 months of age
timeFrame: 3-4 months of age
measure: Hammersmith Infant Neurological Exam (HINE) scores at 6-9 months of age
timeFrame: 6-9 months of age
measure: Test of Infant Motor Performance (TIMP) scores at 3-4 months of corrected age
timeFrame: 3-4 months of corrected age
measure: Peabody Developmental Motor Skills (PDMS-2) at 6-9 months of age
timeFrame: 6-9 months of age
measure: Ages and Stages Questionnaire at 6-9 months of age
timeFrame: 6-9 months of age
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Mariana Baserga, MD
role: PRINCIPAL_INVESTIGATOR
References: