UT Southwestern will lead a multisite study on the use of hypothermia therapy in young children with mild hypoxic-ischemic encephalopathy.
DALLAS – August 02, 2022 – A research team from UT Southwestern Medical Center has been approved for a five-year $7 million funding award from the Patient-Centered Outcomes Research Institute (PCORI). The funding will support multisite clinical research into hypothermia therapy, a cooling treatment that aims to protect the brains of babies who are deprived of oxygen at birth.
Lina Chalak, MD
“I am grateful for this PCORI funding that will help us answer important questions to improve patient care in vulnerable populations,” said Lina Chalak, MD, a professor of pediatrics at UT Southwestern and interim chief of division of Neonatal-Perinatal Medicine at Children’s Health, who will lead the project. “This will be the first study to investigate the effectiveness of cooling for infants suffering from mild hypoxic-ischemic encephalopathy (HIE), a previously unstudied population at risk for brain injury. I look forward to working with families who will participate in the design and dissemination of the trial.”
Every year millions of newborns worldwide suffer brain damage caused by this oxygen deficiency, a condition known as neonatal HIE. Although the World Health Organization estimates that asphyxia at birth is responsible for nearly a quarter of all neonatal deaths, the babies who survive oxygen deprivation are often left with neurological injuries, especially those who do not receive targeted treatment and follow-up, Dr. Chalak explained.
To help improve outcomes, babies diagnosed with moderate and severe HIE are treated with therapeutic hypothermia, using a cooling blanket that lowers body temperature to 33.5 C (92.3 F) — a treatment introduced 15 years ago. the National Institutes of Health’s (NIH) Neonatal Research Network, of which UT Southwestern is a long-time member.
dr. Chalak has focused her clinical and translational research on the prevention of neonatal brain injury and optimization of HIE outcomes, supported by NIH funding and collaborations with nationally funded networks, including the National Institute of Neurological Disorders and Stroke and the Neonatal Research Network.
Randomized trials targeting infants with moderate to severe HIE have shown that therapeutic hypothermia reduces death and disability in this population. Research conducted last year by Dr. Chalak and her team showed that HIE-affected infants treated with hypothermia therapy have an increased risk of seizures and brain damage during the warm-up period, which can be a precursor to disability or death.
The new study will examine the use of hypothermia therapy for patients with mild HIE by comparing the effectiveness of hypothermia at room temperature on neurodevelopmental outcomes after two years; determine the adverse effects of hypothermia therapy on the infant and his/her family; and determine the heterogeneity of treatment effects across mild HIE subgroups as determined by physiological biomarkers. The clinical trial aims to enroll 460 children at 15 locations in the United States, with UT Southwestern as the primary location. In Dallas, babies will be enrolled in the study at UTSW and Parkland Health, with follow-ups at Children’s Health.
“This project was selected for PCORI funding not only for its scientific merit and commitment to involving patients and other healthcare stakeholders in a field study, but also for its potential to answer important questions about hypothermia therapy and provide a crucial answer question. evidence gap,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “We look forward to monitoring the progress of the study and working with UT Southwestern to share the results.”
The price of Dr. Chalak has been approved pending the completion of a business and programmatic review by PCORI personnel and the issuance of a formal award contract.
PCORI is an independent non-profit organization authorized by Congress in 2010. Its mission is to fund research that provides patients, their caregivers, and clinicians with the evidence-based information needed to make more informed health care decisions.
About UT Southwestern Medical Center
UT Southwestern, one of the nation’s premier academic medical centers, integrates cutting-edge biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 26 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. Its full-time faculty of more than 2,900 members is responsible for pioneering medical advances and is committed to quickly translating science-based research into new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 100,000 hospitalized patients, more than 360,000 emergency care cases, and oversee nearly 4 million outpatient visits per year.