Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates

Launched by IPSITA GOSWAMI · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, dexmedetomidine and morphine, to help manage pain and discomfort in newborns who are undergoing cooling therapy for brain injury caused by a lack of oxygen during birth. Cooling therapy is a treatment that can help reduce brain damage in these babies, but it can also cause pain and agitation. The study aims to see if dexmedetomidine, which has shown promise in earlier studies for being safe and potentially beneficial, is more effective than morphine for easing these symptoms and improving overall outcomes for the babies.

To be eligible for this trial, newborns must be at least 35 weeks old, weigh 2500 grams or more, and show signs of a lack of oxygen during birth, along with other conditions. Parents will be asked for consent to participate within the first 20 hours of the baby's life. If they choose to participate, families can expect that the baby will receive either dexmedetomidine or morphine during the cooling treatment and that researchers will monitor the baby's progress closely. This study will help determine if further research comparing these two medications is needed, ultimately aiming to improve care for newborns with brain injuries.

Gender

ALL

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