Vital Signs In Opioid-Exposed Neonates

暴露于阿片类药物的新生儿的生命体征

• 批准号: 10493363
• 负责人: Namasivayam Ambalavanan
• 金额: $ 50.77万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10493363
• 关键词: Age-Months; Alabama; Apnea; Birth; Blood; Bradycardia; Brain; Breathing; Characteristics; Clinical; Clinical Research; Clinical assessments; Complex; Data; Detection; Development; Diagnosis; Doctor of Philosophy; Enrollment; Epidemic; Event; Exposure to; Goals; Heart Rate; Hospitals; Hypoxemia; Infant; Knowledge; Measurement; Methadone; Methods; Modeling; Monitor; Mothers; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Abstinence Syndrome; Neurodevelopmental Impairment; Newborn Infant; Nursing Staff; Opioid; Outcome; Oxygen; Pattern; Pattern Recognition; Perinatal; Pharmaceutical Preparations; Physiological; Polysomnography; Pregnancy; Premature Infant; Prospective cohort; Research; Research Infrastructure; Research Personnel; Risk; Severities; Signal Transduction; Site; Sleep; Sleep Apnea Syndromes; Sudden infant death syndrome; Symptoms; System; Testing; Texas; Training; Translational Research; Universities; Withdrawal; addiction; antenatal; base; clinical research site; cohort; evidence base; follow-up; high risk; high risk infant; improved; in utero; indexing; mathematical model; morphine administration; neonate; opioid exposure; opioid use; opioid withdrawal; participant retention; prevent; programs; prospective; respiratory; signal processing; statistics; treatment response

Project Summary Rates of opioid use during pregnancy are at epidemic proportions. Infants exposed to opioids before birth frequently develop neonatal opioid withdrawal syndrome (NOWS) and are at a much higher risk of sudden infant death syndrome (SIDS). A major knowledge gap is that it not currently possible to determine the magnitude of NOWS or SIDS risk in opioid-exposed infants. Most infants with antenatal opioid exposure are observed for several days after birth in the hospital to determine if the infant develops NOWS. Infants who develop NOWS are frequently managed using the Finnegan scoring system which is complex and subjective. There is therefore a need for rapid objective and quantitative measurement of signs of opioid withdrawal. There is a critical need to determine if the hospital course of NOWS or abnormalities in respiratory control can be predicted soon after birth, in order to initiate earlier monitoring or therapy. Furthermore, it is essential to be able to adjust therapy in a more evidence-based manner. The overall objective of the Vital Signs In Opioid-exposed Neonates (ViSION) project is to use cardiorespiratory dynamics (characteristics and patterns of heart rate, respiratory rate, and oxygen saturations) soon after birth from the existing large cohort of opioid-exposed newborns (>140/yr) at the University of Alabama at Birmingham to develop and validate mathematical models to predict (a) onset of NOWS, (b) changes in magnitude of NOWS as estimated by Finnegan scoring, and (c) abnormal polysomnographic (sleep) study at three months of age. The central hypothesis of this proposed study is that cardiorespiratory dynamics improve detection of NOWS onset and severity, and can predict infants with sleep disordered breathing before discharge. The Specific Aims are: Specific Aim 1: Test the hypothesis that cardiorespiratory dynamics soon after birth identify opioid-exposed neonates at higher risk of neonatal opioid withdrawal syndrome. This hypothesis will be tested in a prospective cohort of 200 opioid-exposed newborn infants and 100 healthy control infants. Specific Aim 2: Test the hypothesis that cardiorespiratory dynamics of infants diagnosed with neonatal opioid withdrawal syndrome track temporally with clinical assessment by the Finnegan scoring. This hypothesis will be tested in a prospective cohort of 100 newborn infants diagnosed with neonatal opioid withdrawal syndrome. Specific Aim 3: Test the hypothesis that intermittent hypoxemia and bradycardia events soon after birth are associated with apnea-hypopnea index on polysomnographic studies at three months of age. This hypothesis will be tested in a prospective cohort of 60 newborn infants diagnosed with NOWS, 60 opioid-exposed infants without NOWS, and 60 healthy control infants.

项目总结