EARLY BLOOD PESSURE MANAGEMENT IN EXTREMELY PRETERM INFANTS FEASIBILITY

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。 学习目标(S)：主要目标： 评估在这组脆弱的患者出生后立即进行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的时间段内安全地识别和随机选择足够数量的患者的能力，并证明该研究可以按计划启动，而不会违反规定的方案超过20%。这包括安全地识别患者的能力，接近被识别的患者的父母，并在压力较大的时候为父母提供关于复杂干预的信息。我们将评估我们及时获得知情同意的能力，在合理的时间框架内随机选择足够数量的患者，并证明研究可以按设计进行。 次要目标： 1.研究氢化可的松、多巴胺或(仅)安慰剂治疗极早产儿出生后24小时内低血压的安全性。这包括安全地管理研究药物的能力，而不会有明显的药物毒性或更频繁的严重不良事件。将监测住院发病率(III级或IV级IVH、囊性PVL、需要手术治疗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)、一周存活率、出院存活率以及开放标签降压治疗的使用)。这些项目在不同分组之间的绝对差异为20%将被认为是可以接受的。

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.