In a groundbreaking study examining the effects of hypothermia on preterm infants suffering from hypoxic ischemic encephalopathy (HIE), researchers have found that this treatment offers no significant benefits compared to standard care. HIE, a condition characterized by brain damage due to a lack of oxygen, has been a serious concern in neonatal care, particularly for infants born preterm at 33 to 35 weeks of gestation. While previous research has indicated that cooling therapy significantly improved outcomes for term and near-term infants, the current findings raise critical questions regarding its efficacy for this vulnerable population.
The study, spearheaded by Dr. Roger G. Faix from the University of Utah in collaboration with 19 newborn research centers, sheds light on this critical area of neonatal care. Published in the esteemed journal JAMA Pediatrics, the research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH). The outcomes of this rigorous trial not only contribute to existing medical literature but also have profound implications for clinical practices surrounding the care of preterm infants.
At birth, preterm infants face myriad challenges, one of the most significant being the risk of HIE, which can result from factors such as umbilical cord compression, uterine tears, or other complications. Understanding the impact of HIE on brain development is crucial for shaping effective interventions. The cooling treatment, previously thought to stabilize and protect the developing brain, cools the body temperature to approximately 92 degrees Fahrenheit. This method gained traction based on earlier studies demonstrating reduced risks of disability and mortality in older infants. However, the new findings suggest that the same benefits do not extend to those born preterm.
Through a randomized clinical trial, the researchers involved 188 preterm infants diagnosed with HIE between the years 2015 and 2020. Divided into two groups, 88 infants received the cooling treatment, while the remaining 80 were kept at their normal body temperature. Notably, when examining outcomes such as mortality rates and instances of moderate to severe disability at 18 to 22 months of age, the results were alarming. The infants who underwent cooling treatment had a significantly higher incidence of both death and disability compared to their counterparts receiving standard care.
Statistically, the findings revealed that 35% of infants subjected to cooling therapy either died or developed a disability, in stark contrast to 29% among those who remained at normal temperature. Particularly distressing was the higher death rate; 20% of those receiving cooling treatment died, compared to just 12% in the standard care group. Such disparities indicate a 74% increased risk of death or disability and an astounding 87% increased risk of death in preterm infants receiving the cooling therapy.
These results underscore the importance of re-evaluating treatment protocols currently in use across neonatal intensive care units (NICUs). The increase in the application of cooling therapy for preterm infants, despite limited supportive research, raises ethical and clinical concerns. The medical community must weigh the risks against the potential benefits in light of this study’s findings. This revelation calls for more comprehensive research focused solely on preterm infants, particularly given the increasing number of cases where cooling therapy has been implemented.
In interviews, Dr. Nahida Chaktoura, chief of NICHD’s Pregnancy and Perinatology Branch, expressed her availability for further discussion on the implications of these findings and their potential impact on future research and neonatal care strategies. The hope is that this study will catalyze a change in practice and lead to improved protocols that better serve the needs of preterm infants diagnosed with HIE.
Medical professionals and researchers alike have been urged to proceed with caution before implementing cooling therapy in preterm infants. The necessity for definitive, evidence-based practice becomes even more critical as we continue to strive for advancements in neonatal care. The findings of this study represent a monumental step forward in understanding the risks associated with hypothermic treatment in one of the most at-risk patient populations.
The relationship between temperature regulation and neurological development remains a complex and multifaceted area of study. As scientists investigate how best to protect the brains of vulnerable newborns, collaboration and comprehensive research efforts will be essential. The ultimate goal remains clear: to find solutions that will minimize the devastating impacts of HIE and improve survival rates and quality of life for preterm infants.
In conclusion, as the field of neonatology evolves, the need for rigorous clinical trials becomes increasingly vital. By addressing the specific needs of preterm infants and understanding the nuances of HIE, we may yet discover new, more effective interventions that can change the course of care for these fragile patients. This study not only opens the door for future investigations but also emphasizes the need for cautious and informed approaches in the treatment of newborns facing the challenges of HIE.
Subject of Research: Effects of cooling therapy on preterm infants with hypoxic ischemic encephalopathy (HIE).
Article Title: Whole-body hypothermia for neonatal encephalopathy in preterm infants 33-35 weeks gestation: a randomized clinical trial.
News Publication Date: (2025).
Web References: link
References: Faix, RG et al. Whole-body hypothermia for neonatal encephalopathy in preterm infants 33-35 weeks gestation: a randomized clinical trial. JAMA Pediatrics DOI:10.1001/jamapediatrics.2024.6613
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Keywords: Infant health, Preterm care, Hypoxic ischemic encephalopathy, Cooling therapy, Neonatal research.
