Neonatal Treatment Trial

新生儿治疗试验

• 批准号: 10891303
• 负责人: Sara Bonamo DeMauro
• 金额: $ 26.4万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10891303
• 关键词: Neonatal; Treatment; Trial

PROJECT SUMMARY Neonatal Opioid Withdrawal Syndrome (NOWS) is a major public health problem in the USA. About 100,000 American infants were exposed to opioids in 2017 and 25,000 of these infants were diagnosed with NOWS. Opioid-exposed infants have poorer outcomes compared to similar non-exposed infants including longer and more complicated initial hospital stays, higher likelihood of involvement in the child welfare system, higher rates of hospital readmission and emergency department visits, and lower use of recommended preventive services. One group of infants at particularly high risk for adverse outcomes are infants who receive pharmacological therapy to treat signs of withdrawal. Importantly, the care, treatment, and outcomes of these infants vary widely between birth hospitals and US states. Such variation suggests that the optimal pharmacological treatment for NOWS remains unknown, potentially exposing these infants to unnecessary or ineffective management. The NOWS Treatment Trial will assess the optimal pharmacological treatment for NOWS through a multicenter, comparative effectiveness trial comparing three commonly used medications. This application describes the CHOP/Penn Neonatal Clinical Trials Network, our outstanding team of investigators with vast clinical trial experience, our unparalleled research environment, and our large and diverse patient population which together ensure that we are ideally suited to participate in the design and execution of the NOWS Treatment Trial. We will contribute expertise in clinical trial methodology, substance abuse, and neonatal follow-up, providing rigorous scientific input into design and implementation of the multicenter NOWS Treatment Trial. We will then execute all aspects of the trial to the highest standard, including robust participant recruitment, rigorous adherence to all aspects of the study protocol, and neurodevelopmental follow-up to two years with minimal attrition.

项目摘要 新生儿阿片类药物戒断综合征（现在）是美国的主要公共卫生问题。大约100,000 美国婴儿在2017年接触阿片类药物，其中25,000名这些婴儿被诊断出患有现在。 与包括较长和更长的非暴露婴儿相比，阿片类药物暴露的婴儿的结局较差 更复杂的初始医院住院，参与儿童福利系统的可能性更高，更高 医院入院率和急诊室就诊，并降低了建议的预防性使用 服务。一组受到不良后果风险的婴儿是接受的婴儿 药理治疗以治疗戒断的迹象。重要的是，这些的护理，治疗和结果 婴儿在出生医院和美国州之间的差异很大。这种变化表明最佳 现在的药理学治疗仍然未知，可能使这些婴儿暴露于不必要的或 无效的管理。 Nows治疗试验将通过A评估现在的最佳药理治疗 比较三种常用药物的多中心，比较有效性试验。此应用程序 描述了我们的杰出调查员团队，描述了Chop/Penn Neonatal临床试验网络 临床试验经验，我们无与伦比的研究环境以及我们庞大多样的患者人群 共同确保我们非常适合参加Nows的设计和执行 治疗试验。我们将在临床试验方法，药物滥用和新生儿方面贡献专业知识 后续措施，为多中心的设计和实施提供了严格的科学意见 治疗试验。然后，我们将以最高标准执行试验的所有方面，包括强大的参与者 招聘，严格遵守研究方案的各个方面，以及两个 年龄最小的损耗。