Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS)

将非药物方法纳入新生儿阿片戒断综合征 (NOWS) 新生儿的比较有效性药理学试验

• 批准号: 10380398
• 负责人: Gregory M. Sokol
• 金额: $ 46.89万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/10380398
• 关键词: Academic Medical Centers; Accounting; Admission activity; Age; Area; Basic Science; Behavior; Birth; Buprenorphine; Caregivers; Caring; Cellular biology; Child; Childhood; Clinical; Clinical Research; Clinical Research Protocols; Clinical Services; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Conduct Clinical Trials; Critical Illness; Data; Development; Diagnosis; Dose; Enrollment; Environment; Evaluation; Faculty; Familiarity; Follow-Up Studies; Genomics; Health; Hospitals; Indiana; Individual; Infant; Infant Care; Intervention; Investigation; Knowledge; Leadership; Length of Stay; Link; Measures; Medical Research; Methadone; Methodist Church; Methods; Morphine; Mothers; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Abstinence Syndrome; Newborn Infant; Nurseries; Outpatients; Patients; Pediatric Hospitals; Pediatric Research; Perinatal; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Pharmacotherapy; Population; Pregnant Women; Principal Investigator; Proteomics; Protocols documentation; Pulmonary Hypertension; Randomized; Randomized Controlled Trials; Research; Research Activity; Research Infrastructure; Research Methodology; Research Personnel; Respiratory Failure; Role; Schedule; Scientific Inquiry; Screening procedure; Standardization; Symptoms; Time; Translational Research; Universities; Urban Hospitals; Weaning; Withdrawal; Withdrawal Symptom; Woman; arm; biomedical referral center; clinical center; comparative effectiveness; comparative effectiveness trial; design; effectiveness clinical trial; experience; falls; follow-up; high risk; improved; inhaled nitric oxide; inner city; innovation; medical schools; neonatal care; neonate; novel; opioid epidemic; patient population; prevent; programs; reduce symptoms; research study; service delivery; standardized care; stem cells; treatment strategy

PROJECT SUMMARY / ABSTRACT The nationwide opioid epidemic includes women of child birthing age accounting for a dramatically increased number of infants being born with neonatal opioid withdrawal syndrome (NOWS). Currently there is no uniformly accepted treatment strategy for NOWS and the choice of primary medication, criteria for treatment, and dosing/weaning schedules vary between centers. Morphine is by far the most commonly used medication for NOWS treatment, followed by methadone. Buprenorphine is a promising drug but with limited studied in this patient population. Additionally, the screening tools used to diagnose NOWS and the appropriate threshold to initiate drug therapy have not been conclusively evaluated. When historical empirically derived drug treatment and weaning protocols have been modified and standardized, reductions of length of stay have been observed. Additionally, nonpharmalogical methods appear to be successful in reducing the symptoms of NOWS. In this application we present preliminary data of a pilot randomized controlled trial currently in progress in our nursery. It includes identifying infants with severe symptoms of NOWS via modified Finnegan scoring, then randomizing them to a standard morphine dosing/weaning schedule, or to an optimal morphine dosing strategy. The optimal morphine dosing strategy does not provide a scheduled dose of morphine, but only provides a dose of morphine when the withdrawal symptoms cannot be satiated through nonpharmacological means. Both study groups received all optimized nonpharmacological methods available to them. In the optimal morphine arm, we observed a large reduction in the use of morphine and in the duration of days receiving pharmacologic therapy. We speculate that the use of the optimal morphine dosing strategy limited the use of pharmacologic treatment to only times when nonpharmacologic interventions were not sufficient. This essentially provided the mother or other care givers time to recognize and adapt to the infant's withdrawal behaviors, enabling them to extinguish them via nonpharmacological means. The optimal morphine dosing strategy also prevented the infant's withdrawal from becoming too symptomatic by allowing morphine to be used when needed, yet not committing the infant to a prolonged scheduled course of morphine treatment and weaning when nonpharmacological measures could have sufficed. Thus, we favor a clinical trial that emphasizes the use of nonpharmacological methods to control withdrawal symptoms irrespective of the drug arm the infant is assigned. However, we favor including a more novel optimal dosing strategy arm rather than limiting the investigation to standard scheduled dosing/weaning arms.

项目摘要/摘要