Clinical trial NCT06985290: Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
Official title: Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hypoxic Ischemic Brain Injury
Neonatal Encephalopathy
Perinatal Anoxic-ischemic Brain Injury
Keywords: sedation
analgesia
dexmedetomidine
morphine
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 50
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: About \~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process. The degree of brain injury that ensues in the first 72 hours after the injury is directly proportional to the severity of long-term childhood disabilities (e.g., cerebral palsy and developmental delays). Whole-body cooling during the first 3 days of life is proven effective in reducing the severity of brain injury. However, cooling therapy leads to pain, shivering, stress, and discomfort. The best way to alleviate the pain and agitation of cooled newborns is unknown. Standard practice is to provide morphine infusion to reduce pain. Recently, a new drug called "dexmedetomidine" has been tested in small studies and has been found to be safe during cooling in newborns. Dexmedetomidine has added beneficial effects such as anti-inflammation, faster recovery, and shorter hospital stays. This study is going to test the feasibility of conducting a future clinical trial to compare the effects of using Dexmedetomidine versus morphine in the management of cooling-related pain/agitation on the severity of brain injury in the first week of life. The study will also examine the effect of dexmedetomidine compared to morphine on short-term clinical outcomes, parental experiences and developmental outcomes at 1 year.


Eligibility criteria: Inclusion criteria:

1. Gestational age \>= 35 weeks
2. Birth weight \>= 2500g
3. Sign of perinatal hypoxic event (any of the following): (a) Arterial Cord blood gas or postnatal gas within 1 hour of life pH \<= 7.00 OR Base Deficit \>= 16 (b) Arterial Cord blood gas postnatal gas within 1 hour of life pH 7.00 -7.15 AND Acute sentinel intrapartum event
4. Sign of Neonatal Encephalopathy
5. Initiation of Therapeutic Hypothermia within 8 hours of life

Exclusion criteria:

1. Informed consent not obtained within 20 hours of life
2. Congenital Brain Malformations (antenatally known)
3. Major Chromosomal Anomaly (antenatally diagnosed)
4. Congenital neuromuscular disorder

Primary outcomes:
measure: Recruitment Rate
timeFrame: Day 1
measure: Follow Up Rate
timeFrame: From enrollment to 1 year of age
measure: Adverse Event Rate
timeFrame: From enrollment to 7 days of life
measure: Discontinuation Rate
timeFrame: From enrollment to 7 days of life
measure: Protocol Adherence Rate
timeFrame: through study completion, average 1 year
Secondary outcomes:
measure: Severity of Brain Injury on Magnetic Resonance Imaging (MRI)
timeFrame: From enrollment to 10 days of life
measure: Seizure Burden during Therapeutic Hypothermia
timeFrame: From enrollment to 72 hours of life
measure: Stress levels measured by Salivary cortisol assay at 24 and 48 hours
timeFrame: From enrollment to 48 hours of life
measure: Neonatal Sedation and Discomfort Levels
timeFrame: From enrollment to 4 days of life
measure: Time to Reach Full Oral Feeds
timeFrame: up to 4 weeks of life
measure: Cumulative dose of PRN opioid boluses given during therapeutic hypothermia
timeFrame: up to 4 days of life
measure: Length of Hospital Stay
timeFrame: up to 4 weeks of life
measure: Days on invasive and non-invasive respiratory support
timeFrame: Up to 4 weeks of life
Other outcomes:
measure: Parental Stress Index
timeFrame: Up to 4 weeks of life
measure: Parental Experiences
timeFrame: From discharge to 4 weeks post-discharge
measure: Developmental Outcomes at 12 months
timeFrame: Between 10-14 months of enrollment
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Ipsita Goswami, MD
role: PRINCIPAL_INVESTIGATOR
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