Neonatal Treatment Trial

新生儿治疗试验

• 批准号: 10379584
• 负责人: Sara Bonamo DeMauro
• 金额: $ 52.8万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379584
• 关键词: Accident and Emergency department; Adherence; American; Birth; Caring; Child Welfare; Clinic; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Country; Data; Diagnosis; Eating; Emergency department visit; Ensure; Environment; Exposure to; Funding; Geographic state; Grant; Health Expenditures; Hospitals; Incidence; Infant; Infant Care; Intensive Care; Lead; Length; Length of Stay; Longitudinal Studies; Methadone; Methodology; Morphine; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Abstinence Syndrome; Newborn Infant; Nurseries; Opioid; Outcome; Participant; Patient Recruitments; Pediatric Hospitals; Pennsylvania; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Phase; Philadelphia; Preventive service; Procedures; Protocols documentation; Public Health; Research; Research Infrastructure; Research Personnel; Site; Sleep; Substance abuse problem; System; Training; Treatment outcome; Universities; Variant; Withdrawal; Work; adverse outcome; clinical epidemiology; clinical infrastructure; clinical research site; comparative effectiveness trial; design; experience; follow-up; high risk; high standard; infant outcome; meetings; member; opioid exposure; patient population; randomized trial; readmission rates; recruit; success; treatment trial; trial comparing

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.

项目总结 新生儿阿片类药物戒断综合征(NOWS)在美国是一个主要的公共卫生问题。大约100,000 2017年，美国婴儿接触阿片类药物，其中25,000名婴儿被诊断为NOWS。 与类似的非接触阿片类药物的婴儿相比，接触阿片类药物的婴儿结局更差，包括更长和 初始住院时间越复杂，参与儿童福利制度的可能性就越高 再次住院率和急诊科就诊率，以及较低的建议预防措施使用率 服务。有一组婴儿的不良结局风险特别高，他们接受了 治疗戒断症状的药物疗法。重要的是，这些疾病的护理、治疗和结果 不同的产医院和美国各州的婴儿差别很大。这种差异表明，最优的 NOWS的药物治疗仍不清楚，可能会使这些婴儿暴露在不必要的或 管理不力。 NOWS治疗试验将评估NOWS的最佳药物治疗方法 三种常用药物的多中心比较疗效试验。此应用程序 描述CHOP/宾夕法尼亚大学新生儿临床试验网络，该网络是我们杰出的研究团队，拥有大量 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群体 它们共同确保我们非常适合参与NOWS的设计和实施 治疗试验。我们将在临床试验方法学、药物滥用和新生儿方面提供专业知识 后续行动，为多中心NOWS的设计和实施提供严格的科学投入 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 招募，严格遵守研究方案的所有方面，以及对两个 减员最少的年份。