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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 中心，不一定是研究者的机构。 本研究旨在研究对出生6小时后的新生儿进行诱导性低温治疗，以减少新生儿缺氧缺血性脑病（HIE）的死亡并改善其预后。 缺氧缺血性脑病是由于包括大脑在内的身体所有器官的血流和氧气减少（由感染或胎盘/脐带问题引起）。 在新生儿缺氧缺血性脑病中存活的婴儿死亡或残疾的风险为50%。 目前，被诊断患有HIE的婴儿不到6小时的年龄被冷却，以降低他们的体温91.4-93.2华氏度72小时。 之前的动物和人类研究表明，诱导低温似乎是保护婴儿大脑的最有希望的治疗方法。安全信息显示，在最初72小时内冷却的新生儿没有不良影响。 信息表明脑损伤发生在HIE后数天至数周。 尚不清楚诱导性低温在较晚年龄[6小时后]开始是否有益。 一些患有HIE的婴儿还没有到达提供诱导低温的医院，或者可能直到他们6小时大之后才显示出HIE的迹象。 也不知道更长时间的诱导低温[超过72小时]是否有益。 本研究的目的是评估在预产期4周内出生并显示HIE体征的婴儿在6至24小时内开始并持续96小时的诱导低温是否会减少死亡并改善18个月的结局。

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.