Neonatal Treatment Trial

项目摘要 新生儿阿片类戒断综合征（NOWS）是美国的一个主要公共卫生问题。约10万 2017年，美国婴儿暴露于阿片类药物，其中25，000名婴儿被诊断患有NOWS。 与类似的非暴露婴儿相比，暴露于阿片类药物的婴儿的结局较差， 初始住院时间越复杂，参与儿童福利系统的可能性越高， 再入院率和急诊就诊率，以及推荐的预防性药物使用率降低 服务一组婴儿在特别高的风险，为不良后果的婴儿谁收到 药物治疗以治疗戒断症状。重要的是，这些患者的护理、治疗和结果 出生医院和美国各州之间的婴儿差异很大。这种变化表明， NOWS的药物治疗仍然未知，可能使这些婴儿暴露于不必要的或 管理不力。 NOWS治疗试验将通过以下方式评估NOWS的最佳药物治疗： 多中心，比较有效性试验，比较三种常用药物。本申请 描述了CHOP/Penn新生儿临床试验网络，我们杰出的研究团队， 临床试验经验，我们无与伦比的研究环境，以及我们庞大而多样化的患者群体 这些因素共同确保我们非常适合参与NOWS的设计和执行 治疗试验。我们将在临床试验方法学、药物滥用和新生儿 随访，为多中心NOWS的设计和实施提供严格的科学输入 治疗试验。然后，我们将以最高标准执行试验的各个方面，包括健壮的参与者 招募，严格遵守研究方案的各个方面，并对两名患者进行神经发育随访。 年，以最小的磨损。

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.