Status:
NOT_YET_RECRUITING
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
Lead Sponsor:
Ipsita Goswami
Conditions:
Hypoxic Ischemic Brain Injury
Neonatal Encephalopathy
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
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 h...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Gestational age \>= 35 weeks
- Birth weight \>= 2500g
- 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
- Sign of Neonatal Encephalopathy
- Initiation of Therapeutic Hypothermia within 8 hours of life
- Exclusion criteria:
- Informed consent not obtained within 20 hours of life
- Congenital Brain Malformations (antenatally known)
- Major Chromosomal Anomaly (antenatally diagnosed)
- Congenital neuromuscular disorder
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06985290
Start Date
July 1 2025
End Date
June 30 2028
Last Update
May 22 2025
Active Locations (1)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N3Z5