UPMC Newborn Medicine Program Participating in COOLPRIME Clinical Trial

The UPMC Newborn Medicine Program is one of 15 centers participating in the COOLPRIME clinical trial that is being sponsored by the University of Texas Southwestern Medical Center in Dallas with Lina Chalak, MD, as the study’s principal investigator.

COOLPRIME, or the Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy, is a multicenter observational study investigating the potential efficacy of therapeutic hypothermia (TH) versus normothermia in improving neurodevelopmental outcomes for infants diagnosed with mild Hypoxic-Ischemic Encephalopathy (HIE).

Toby D. Yanowitz, MD, MS, associate professor of Pediatrics in the Division of Newborn Medicine and director of the Neuro-NICU for the division of Newborn Medicine, is the site PI for the study. Dr. Yanowitz is also director of Newborn Clinical Research, and director of Neonatology Data Analytics in the Division. Collaborating with Dr. Yanowitz to conduct the study at UPMC is co-PI John Ibrahim, MD, FAAP.

TH and HIE

Therapeutic hypothermia for newborns is currently standard of care for babies with moderate-severe HIE, a condition in which infants have significant encephalopathy right after birth because of rare conditions that severely compromise placental flood flow just prior to delivery. 

The hypothermia treatment is thought to be beneficial in reducing brain damage from HIE by cooling the infant's body temperature, thus slowing metabolic processes that result in cellular injury following reduced oxygen delivery and brain blood flow. By decreasing the rate of cellular damage and death through cooling of the body, therapeutic hypothermia may improve long-term neurodevelopmental outcomes, minimizing potential cognitive and motor impairments that are associated with cases of HIE.

Although this is now standard of care for babies with moderate-severe HIE, this treatment has not been studied in large randomized-controlled studies for babies with only mild HIE. Thus, the benefits for newborns with mild HIE are less clear. Neonatal Intensive Care Units (NICUs) across the United States are split as to whether they provide therapeutic hypothermia to infants with mild HIE.

More Study Details

COOLPRIME is an observational, comparative effectiveness study that is evaluating the impact of TH compared to normal temperature management in treating infants with mild HIE. At the 15 trial centers, the study will measure how effective TH is in enhancing neurodevelopmental outcomes measured at 2 years of age. The study will also examine any negative effects of TH on both infants and their families and assess how these effects vary among different subgroups based on early physiological markers.

The decision on whether to use TH or normothermia treatments for each enrolled participant are set by each site's standard practices of care. Enrollment in the study will take place over the next three years, and results are expected shortly after the last enrolled infant has their 2-year developmental assessment.

Further Reading

Read more about the study protocol at ClinicalTrials.gov (NCT04621279).