Indomethacin and delayed umbilical cord clamp for preterm infant IVH

吲哚美辛联合延迟脐带钳治疗早产儿 IVH

• 批准号: 8843630
• 负责人: John Anthony Bauer
• 金额: $ 60.4万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8843630
• 关键词: Indomethacin; delayed; umbilical; cord; clamp

DESCRIPTION (provided by applicant): Intraventricular hemorrhage (IVH) during the neonatal period is a common occurrence in preterm infants and is a well-recognized major contributor to brain injury and related disabilities later in life. Infants who develop severe IVH are at significant risk for developmental disabilities, including cerebral palsy and/or major cognitive handicaps. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined. Only one therapy, prophylactic indomethacin during the first 3 days of life, has consistently been shown to prevent or decrease the severity of IVH in preterm infants but its use is severely limited by the drug's toxic side effects and its controversial efficacy with respect to long-term outcomes. Indomethacin side effects are severe and include gastrointestinal perforation, renal toxicity and related organ failure, and actual extension of an established intra-cranial bleeding episode. Recent studies suggest that delayed umbilical cord-clamping (DCC) may decrease the incidence of IVH. However, at least in the largest study, all the infants received prophylactic indomethacin along with delaying of the cord clamp. These two modalities in combination may have advantages with respect to efficacy or safety when compared to prophylactic indomethacin used alone. Our Aims are 1) Compare efficacy and safety of prophylactic indomethacin with vs. without DCC cord clamp in affecting the incidence and severity of IVH in preterm (gestational age <30wks), and 2) Investigate mechanistic interactions of DCC and indomethacin in VLBW infants. This project may improve the safety and use of prophylactic indomethacin and further define the medical value, potential mechanisms, and optimal implementation strategies for DCC.

描述（由申请人提供）：新生儿期脑室内出血（IVH）在早产儿中很常见，并且是公认的导致以后生活中脑损伤和相关残疾的主要原因。患有严重脑室内出血的婴儿面临着发育障碍的重大风险，包括脑瘫和/或严重认知障碍。尽管 IVH 普遍存在、具有长期后果以及巨大的医疗和社会成本，但 IVH 的机制以及预防或治疗其发生的最佳策略尚不清楚。只有一种治疗方法，即出生后 3 天内预防性使用吲哚美辛，一直被证明可以预防或减轻早产儿 IVH 的严重程度，但其使用受到该药物的毒副作用及其长期疗效争议的严重限制。期限结果。吲哚美辛的副作用很严重，包括胃肠道穿孔、肾毒性和相关器官衰竭，以及已确定的颅内出血事件的实际延长。最近的研究表明，延迟脐带结扎 (DCC) 可能会降低 IVH 的发生率。然而，至少在最大的研究中，所有婴儿都接受了预防性吲哚美辛，同时延迟了脐带钳夹。与单独使用预防性吲哚美辛相比，这两种方式的组合可能在功效或安全性方面具有优势。我们的目标是 1) 比较预防性吲哚美辛与不使用 DCC 脐带钳对早产儿（胎龄 <30 周）IVH 发生率和严重程度的影响的有效性和安全性，以及 2) 研究 DCC 和吲哚美辛在 VLBW 婴儿中的机制相互作用。该项目可以提高预防性吲哚美辛的安全性和使用，并进一步明确 DCC 的医学价值、潜在机制和最佳实施策略。