EARLY BLOOD PESSURE MANAGEMENT IN EXTREMELY PRETERM INFANTS FEASIBILITY

这个子项目是许多利用 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， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 研究目的：主要目的： 评估在这组脆弱患者中进行产后即刻BP管理的随机对照试验（RCT）的可行性。我们将可行性定义为在合理时间段内安全识别和随机分配足够数量患者的能力，并证明研究可以按计划启动，而没有超过20%的特定方案违背。这包括能够安全地识别患者，接近已识别患者的父母，并在紧张的时候为父母提供有关复杂干预的信息。我们将评估我们及时获得知情同意的能力，在合理的时间范围内随机分配足够数量的患者，并证明研究可以按设计进行。 次要目的： 1.研究在出生后24小时内给予低血压极早产儿氢化可的松、多巴胺或（仅）安慰剂治疗的安全性。这包括安全给予研究药物而没有显著药物毒性或更频繁的严重不良事件的能力。将监测住院发病率（III级或IV级IVH、囊性PVL、需要手术干预的坏死性小肠结肠炎（NEC）、需要激光手术的早产儿视网膜病变（ROP）或支气管肺发育不良（BPD））、1周生存率、出院生存率和开放标签抗水肿治疗的使用。亚组间任何这些事件的绝对差异20%将被视为可接受。

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. Study Aim(s): Primary aim: Evaluate the feasibility of performing a randomized controlled trial (RCT) of BP management in this group of vulnerable patients in the immediate postnatal period. We define feasibility as the ability to safely identify and randomize a sufficient number of patients within a reasonable time period and to demonstrate that the study can by initiated as planned without specified protocol violations exceeding 20%. This includes the ability to safely identify patients, approach the parents of identified patients, and provide parents with information about a complex intervention at a stressful time. We will evaluate our ability to obtain informed consent in a timely manner, randomize a sufficient number of patients in a reasonable time frame, and demonstrate that the study can be conducted as designed. Secondary aims: 1. To investigate the safety of administering hydrocortisone, dopamine, or (only) placebo therapy to extremely preterm infants with low BP in the first 24 postnatal hours. This includes the ability to safely administer study drugs without significant drug toxicity or more frequent severe adverse events. Rates of in-hospital morbidity (grade III or IV IVH, cystic PVL, Necrotizing Enterocolitis (NEC) requiring surgical intervention, Retinopathy of Prematurity (ROP) requiring laser surgery, or Bronchopulmonary Dysplasia (BPD), one week survival, survival to hospital discharge, and use of open-label anti-hypotensive therapies will be monitored. An absolute difference of 20% in any of these events across subgroups will be considered acceptable.