Cooling Therapy Shows No Benefit for Preterm Infants with Brain Injury, NIH Study Finds
Key Insights
A large NIH-funded clinical trial reveals that therapeutic hypothermia, previously successful in term infants, offers no protection against death or disability in preterm infants with hypoxic ischemic encephalopathy (search).
The study of 188 preterm infants found that cooling treatment actually increased risk of death or disability by 74%, with mortality rates of 20% in the treatment group versus 12% in standard care.
Research conducted across 19 newborn centers challenges the growing practice of using cooling therapy in preterm infants, highlighting the importance of gestational age-specific treatments.
A major clinical trial funded by the National Institutes of Health has revealed that therapeutic hypothermia, a cooling treatment commonly used to protect infant brains after oxygen deprivation, provides no benefit for preterm infants born between 33 and 35 weeks of pregnancy. The findings challenge the increasing use of this treatment in premature babies.
Treatment Outcomes and Risk Analysis
The multicenter study, led by Dr. Roger G. Faix of the University of Utah, evaluated 188 preterm infants with hypoxic ischemic encephalopathy (search) (HIE (search)) born between 2015 and 2020. The research team randomly assigned 88 infants to receive cooling treatment, which lowered body temperature to approximately 92 degrees Fahrenheit, while 80 infants received standard care at normal temperature.
The results were concerning: infants who received cooling therapy showed a 74% higher risk of death or disability compared to those who received standard care. More alarmingly, the mortality rate was significantly higher in the cooling treatment group at 20%, compared to 12% in the standard care group.
Contrast with Previous Research
These findings stand in stark contrast to earlier studies involving near-term and full-term infants (born after 36 weeks), where therapeutic hypothermia demonstrated significant benefits in reducing death and disability risks by 18 months of age. The disparity highlights the critical importance of considering gestational age when determining treatment protocols.
Clinical Implications
The study raises important concerns about the growing practice of using cooling therapy in preterm infants, which has increased despite limited research supporting its effectiveness in this age group. HIE (search), which can occur due to various birth complications such as umbilical cord compression or uterine tears, requires careful consideration of treatment approaches based on gestational age.
Assessment Methods
Researchers conducted follow-up evaluations when the infants reached 18 to 22 months of age, corrected for prematurity. The comprehensive assessment revealed that 35% of infants in the cooling treatment group either died or developed moderate to severe disabilities, compared to 29% in the standard care group.
These findings emphasize the need for alternative therapeutic strategies for preterm infants with HIE (search) and underscore the importance of gestational age-specific treatment protocols in neonatal care.