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Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates: A Pilot Randomized Trial
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
McMaster Children's Hospital
Hamilton, Ontario, Canada
Start Date
July 1, 2025
Primary Completion Date
September 30, 2027
Completion Date
June 30, 2028
Last Updated
May 22, 2025
50
ESTIMATED participants
Dexmedetomidine Infusion
DRUG
Morphine Infusion
DRUG
Lead Sponsor
Ipsita Goswami
NCT02544100
NCT03706417
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06985303