ASSESSMENT OF THE SAFETY AND EFFICACY OF DARBEPOIETIN ALFA IN PRETERM INFANTS

达贝泊汀 α 在早产儿中的安全性和有效性评估

• 批准号: 7605143
• 负责人: ADAM A ROSENBERG
• 金额: $ 7.03万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605143
• 关键词: Anemia; Animal Model; Brain; Computer Retrieval of Information on Scientific Projects Database; Developmental Delay Disorders; Dose; Erythrocytes; Erythropoietin; Funding; Grant; Hypoxia; Infant; Injury; Institution; Outcome; Premature Infant; Prematurity of fetus; Production; Research; Research Personnel; Resources; Reticulocytes; Risk; Safety; Schedule; Source; Transfusion; United States National Institutes of Health; Week; intraventricular hemorrhage; prevent; protective effect; recombinant human erythropoietin; subcutaneous

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. Studies evaluating the use of recombinant human erythropoietin (rHuEpo) in preterm infants proved it to be safe and effective. Preterm infants respond to human recombinant erythropoietin (Epo) by increasing reticulocytes, yet the multiple subcutaneous doses diminish its routine use in the NICU. The use of darbepoetin, a slightly modified form of erythropoietin, can be administered once a week or every other week to prevent and treat anemia of prematurity, a promising alternative because the dosing schedule would be more efficacious for extremely small infants. In addition to stimulating red cell production, rHuEpo has been shown to be protective in the developing brain, making it possibly beneficial for very premature infants who are at risk for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. In animal models, darbepoetin shows the same protective effect as rHuEpo, and it is reasonable to postulate that the use of darbepoetin will eliminate the need for transfusion in some preterm infants, and reduce the need in others. We plan to evaluate both hematologic and neurodevelopmental outcomes in preterm infants treated with darbepoetin.

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。 评估重组人促红细胞生成素(RHuEPO)在早产儿中的应用的研究证明，它是安全有效的。早产儿对人类重组促红细胞生成素(EPO)的反应是通过增加网织红细胞，但多次皮下注射减少了它在NICU中的常规使用。达贝泊丁是一种略微改良的促红细胞生成素，可以每周或每隔一周给药一次，以预防和治疗早产儿贫血，这是一个很有前途的替代方案，因为给药时间表对极小的婴儿更有效。除了刺激红细胞的产生，rHuEPO已被证明在发育中的大脑中具有保护作用，使其可能有益于极早产儿，他们有脑室出血、缺氧缺血损伤和发育延迟的风险。在动物模型中，Darbepoetin显示出与rHuEPO相同的保护作用，可以合理地假设，Darbepoetin的使用将消除一些早产儿输血的需要，并减少另一些早产儿的输血需要。我们计划评估达贝泊丁治疗早产儿的血液学和神经发育结果。