Dexmedetomidine for Neonatal Encephalopathy

(COOL-SED Trial)

Overseen By IPSITA GOSWAMI, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Ipsita Goswami

Disqualifiers: Congenital brain malformations, major chromosomal anomaly, congenital neuromuscular disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

50 Participants Needed

Trial Summary

What is the purpose of this 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.

Research Team

Ipsita Goswami, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for newborns who have suffered brain injury due to oxygen deprivation during birth. They must be undergoing cooling therapy within the first 72 hours of life to reduce brain injury severity. Specific eligibility details are not provided, but typically include certain health parameters and parental consent.

Inclusion Criteria

My treatment with cooling therapy started within 8 hours of being born.

Sign of perinatal hypoxic event: (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

Gestational age >= 35 weeks

Exclusion Criteria

Congenital Brain Malformations (antenatally known)

My unborn baby has been diagnosed with a major chromosomal anomaly.

Congenital neuromuscular disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Dexmedetomidine or Morphine infusion as sedation during therapeutic hypothermia and rewarming

3 days

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including developmental outcomes at 1 year

1 year

Regular follow-up visits and assessments

Extension

Parental experiences and stress levels are assessed post-discharge

4 weeks post-discharge

Treatment Details

Interventions

• Dexmedetomidine
• Morphine

Trial Overview The study compares two drugs: Dexmedetomidine and Morphine, both given through an infusion to manage pain in cooled newborns with brain injuries. It aims to determine which drug better reduces pain and improves outcomes like recovery time and developmental progress at one year.

Participant Groups

Group I: Dexmedetomidine Group Experimental Treatment 1 Intervention

Dexmedetomidine infusion as sedation during therapeutic hypothermia and rewarming

Group II: Morphine Group Active Control 1 Intervention

Morphine infusion as sedative during therapeutic hypothermia and rewarming

Who Is Running the Clinical Trial?

Ipsita Goswami

Lead Sponsor