Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study

This observational study collected information on the incidence and management of hypotension in babies born at term or late preterm that were admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research Network (NRN). Participants included all newborn infants born at 34 0/7 weeks gestation or greater who were admitted to NICU Network centers and intubated and mechanically ventilated at less than 72 hours of age. The information gathered provided a framework for the design of a potential randomized controlled trial for the treatment of hypotension in neonates. This observational study was for a time-limited enrollment period; NRN centers enrolled until at least 50 patients were enrolled per center (for 800-1,000 subjects total). More than half of the infants (N=419) met at least one definition of cardiovascular insufficiency (CVI). However, almost half of the treated infants met none of the definitions. Inotropic therapy was associated with increased mortality.本观察性研究针对新生儿研究网络（Neonatal Research Network，NRN）下属各新生儿重症监护病房（Neonatal Intensive Care Units，NICU）收治的足月儿与晚期早产儿的低血压发生率及诊疗管理情况开展了信息采集。研究对象涵盖所有胎龄≥34周0/7天，且于出生后72小时内接受气管插管与机械通气、入住NRN网络中心的新生儿。本次采集的数据可为新生儿低血压治疗相关潜在随机对照试验的设计提供参考框架。本研究设有入组时限：NRN各中心需完成至少50例入组病例，最终总入组规模预计为800至1000例受试者。超过半数的新生儿（N=419）符合至少1项心血管功能不全（cardiovascular insufficiency，CVI）的诊断标准，然而近半数接受治疗的新生儿未满足任何一项上述诊断标准。正性肌力药物治疗与死亡率升高存在相关性。