EVALUATION OF SYSTEMIC HYPOTHERMIA INITIATED AFTER 6 HOURS OF AGE IN INFANTS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research is studying body cooling begun in newborns after 6 hours of age to reduce death and improve outcomes of infants with Hypoxic-Ischemic Encephalopathy [HIE]. HIE results from decreased blood flow and oxygen to all organs in the body including the brain. In term infants [babies born near their due dates] certain signs of HIE follow a sudden lack of oxygen. Some of the causes include acute infections and problems with the placenta and/or the umbilical cord. The risk of death and the risk of handicaps [like cerebral palsy, blindness, or deafness] in infants who survive moderate and severe encephalopathy [effects of decreased oxygen in the brain] is 50%. If a baby has seizures shortly after birth, there is a high risk of disability. At this time, infants with HIE diagnosed at less than six hours of age are cooled on a cooling blanket to decrease their body temperature to 33-34o C [91.4-93.2o F] for 72 hours. Mildly decreasing the baby's body temperature [induced hypothermia] appears to be the most promising treatment to protect babies' brains that has come from studies of animals, adults, and babies to date. Safety studies done in newborn babies who were cooled in the first 72 hours of life have shown no bad side effects. There is information to suggest brain injury occurs over a long period of time [days to weeks following HIE]. It is unknown if induced hypothermia is of benefit when started at a later age [after 6 hours]. Some infants with HIE have not yet arrived at a hospital where induced hypothermia is offered, or may not show signs of moderate to severe HIE until after they are 6 hours old. It is also not known if a longer period of induced hypothermia [more than 72 hours] may be beneficial. The purpose of this research study is to evaluate whether induced hypothermia with body cooling begun between 6 and 24 hours of age and continuing 96 hours in infants who were born within 4 weeks of their due date and who show signs of HIE will reduce death and improve outcomes at 18 months of age.