Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates (COOL-SED)

Ipsita Goswami

Status and phase: Not yet enrolling; Phase 2

Conditions: Hypoxic Ischemic Brain Injury; Perinatal Anoxic-ischemic Brain Injury; Neonatal Encephalopathy

Treatments: Drug: Dexmedetomidine Infusion; Drug: Morphine Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06985290

20027280

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 20 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

Dexmedetomidine infusion as sedation during therapeutic hypothermia and rewarming

Treatment:

Drug: Dexmedetomidine Infusion

Morphine Group

Active Comparator group

Description:

Morphine infusion as sedative during therapeutic hypothermia and rewarming

Treatment:

Drug: Morphine Infusion