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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究是研究新生儿出生后6小时内的诱导低温，以减少新生儿缺氧缺血性脑病[HIE]的死亡率和改善预后。 HIE的原因是体内所有器官包括大脑的血流量和氧气减少(由感染或胎盘/脐带问题引起)。存活HIE的婴儿死亡或残疾的风险为50%。 目前，被诊断为HIE的婴儿出生不到6小时，需要降温以降低他们的体温，降温时间为华氏91.4-93.2华氏度，持续72小时。之前的动物和人类研究表明，诱导低温似乎是最有希望保护婴儿大脑的治疗方法。新生儿在出生后72小时内的安全信息并未显示出不良影响。 信息表明，脑损伤在HIE后几天到几周内发生。目前尚不清楚如果在较晚的年龄[6小时后]开始诱导降温是否有益。一些患有HIE的婴儿还没有到达提供诱导降温的医院，或者可能在他们6小时大后才显示出HIE的迹象。更长时间的诱导降温[超过72小时]是否有益也是未知的。 这项研究的目的是评估在预产期4周内出生且有HIE迹象的婴儿在6至24小时内开始诱导低温并持续96小时是否能减少死亡并改善18个月的预后。

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 induced hypothermia 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 (caused by infections or placenta/umbilical cord problems). The risk of death or handicaps in infants who survive HIE is 50%. Presently, infants diagnosed with HIE less than six hours of age are cooled to decrease their body temperature 91.4-93.2 degrees F for 72 hours. Previous animal and human research has shown that induced hypothermia appears to be the most promising treatment to protect babies brains. Safety information in newborn babies cooled in their first 72 hours have shown no bad effects. Information suggests brain injury occurs over days to weeks following HIE. It is unknown if induced hypothermia is beneficial if 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 HIE until after they are 6 hours old. It is also unknown if a longer period of induced hypothermia [more than 72 hours] may be beneficial. The purpose of this study is to evaluate whether induced hypothermia 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.