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; 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.

项目摘要 怀孕期间使用阿片类药物的速率为流行比例。婴儿之前接触阿片类药物 出生经常发展新生儿阿片类药物戒断综合征（现在），并且有更高的风险 猝死综合征（SIDS）。一个主要的知识差距是目前无法确定 如今暴露于阿片类药物的婴儿的现状或小晶型的大小风险。大多数患有产前阿片类药物的婴儿 在医院出生后几天观察到，以确定婴儿现在是否出现。婴儿谁 现在，使用复杂且主观的Finnegan评分系统来管理开发。 因此，需要快速客观和定量测量阿片类药物戒断的迹象。 迫切需要确定呼吸控制中现在的医院或异常情况 出生后不久就可以预测，以启动早期的监测或治疗。此外，必须 能够以更基于证据的方式调整治疗。 阿片类药物暴露的新生儿（视觉）项目中生命体征的总体目标是使用 心肺动力学（心率，呼吸速率和氧饱和的特征和模式） 现有大型阿片类药物暴露的新生儿（> 140/年）出生后不久 伯明翰的阿拉巴马州开发和验证数学模型以预测（a）Nows的发作，（b） Finnegan评分估计的Now幅度变化，以及（c）异常的多摄影学 （睡眠）三个月大的研究。这项拟议的研究的中心假设是心肺 动力学改善了现在的发作和严重程度的检测，可以预测睡眠失调的婴儿 出院前呼吸。具体目的是： 特定目的1：检验以下假设：出生后不久心肺动力学识别暴露于阿片类药物 新生儿新生儿戒断综合征的风险更高。该假设将在 前瞻性队列有200名阿片类药物暴露的新生婴儿和100名健康对照婴儿。 特定目的2：检验以下假设：诊断为新生儿的婴儿的心肺动力学 阿片类药物戒断综合征曲目在临时评估临床评估上。这 假设将在诊断为新生儿阿片类药物的100名新生婴儿的前瞻性队列中进行检验 戒断综合征。 特定目的3：检验以下假设：出生后不久之后不久的间歇性低氧血症和心动过缓事件是 与三个月大的多肌流学研究有关的呼吸暂停指数有关。这个假设 将在诊断为60名阿片类药物暴露的婴儿的60名新生婴儿的前瞻性队列中进行测试 没有现在，还有60名健康对照婴儿。