EARLY BLOOD PESSURE MANAGEMENT IN EXTREMELY PRETERM INFANTS FEASIBILITY

极早产儿早期血压管理的可行性

• 批准号: 8166638
• 负责人: KRISTI L. WATTERBERG
• 金额: $ 0.21万
• 依托单位: UNIVERSITY OF NEW MEXICO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166638
• 关键词: Antihypertensive Agents; Blood; Bronchopulmonary Dysplasia; Complex; Computer Retrieval of Information on Scientific Projects Database; Dopamine; Drug toxicity; Event; Funding; Grant; Hospitals; Hour; Hydrocortisone; Informed Consent; Institution; Intervention; Laser Surgery; Monitor; Morbidity - disease rate; Necrotizing Enterocolitis; Operative Surgical Procedures; Parents; Patients; Pharmaceutical Preparations; Placebos; Premature Infant; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Retinopathy of Prematurity; Safety; Severe Adverse Event; Source; Specific qualifier value; Subgroup; Time; United States National Institutes of Health; Vulnerable Populations; design; open label; postnatal; protocol violation

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 研究目标： 主要目标： 评估在这组弱势患者产后立即进行血压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分配足够数量的患者的能力，并证明研究可以按计划启动，且规定的方案违规率不超过 20%。这包括能够安全地识别患者、联系已识别患者的父母以及在压力时期向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。 次要目标： 1. 调查对出生后 24 小时内血压较低的极早产儿给予氢化可的松、多巴胺或（仅）安慰剂治疗的安全性。这包括能够安全地施用研究药物，而不会出现明显的药物毒性或更频繁的严重不良事件。院内发病率（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)、一周生存率、出院生存率，并且将监测开放标签抗低血压疗法的使用。亚组中任何这些事件的绝对差异都将受到 20% 的影响。认为可以接受。