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: 10360908
• 负责人: Namasivayam Ambalavanan
• 金额: $ 51.99万
• 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/10360908
• 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; Structure; 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; response; 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 怀孕期间阿片类药物的使用率处于流行水平。婴儿以前接触过阿片类药物 新生儿经常患上阿片类药物戒断综合征(NOWS)，并有更高的患病风险 婴儿猝死综合征(SIDS)。一个主要的知识差距是，目前还不可能确定 暴露于阿片类药物的婴儿中NOWS或SID风险的大小。大多数出生前接触阿片类药物的婴儿 出生后在医院观察几天，以确定婴儿是否发展为NOWS。婴儿谁是 开发NOW经常使用芬尼根评分系统进行管理，这是复杂和主观的。 因此，有必要对阿片类药物戒断迹象进行快速、客观和定量的衡量。 迫切需要确定NOWS的住院病程或呼吸控制异常是否可以 在出生后不久被预测，以便启动更早的监测或治疗。此外，有必要成为 能够以更循证的方式调整治疗。 暴露于阿片类药物的新生儿生命体征(VISION)项目的总体目标是使用 心肺动力学(心率、呼吸频率和氧饱和度的特征和模式) 出生后不久，从现有的大量阿片类药物暴露的新生儿队列(&gt；140/年) 阿拉巴马州伯明翰大学开发和验证数学模型以预测(A)NOWS的发生，(B) (C)多导睡眠图异常 (睡觉)在三个月大的时候学习。这项拟议研究的中心假设是心肺功能 动力学改善了NOWS的发病和严重程度的检测，并可以预测睡眠障碍的婴儿 出院前的呼吸。具体目标是： 具体目标1：检验出生后不久心肺动力学确定阿片类药物暴露的假设 新生儿阿片类药物戒断综合征风险较高的新生儿。这一假设将在一个 200名接触阿片类药物的新生儿和100名健康对照婴儿的前瞻性队列。 具体目标2：检验诊断为新生儿的婴儿的心肺动力学假设 阿片类药物戒断综合征与临床评估的芬尼根评分暂时性追踪。这 假说将在100名被诊断为新生儿阿片类药物的新生儿中进行前瞻性队列测试 戒断综合症。 具体目标3：检验出生后不久发生间歇性低氧血症和心动过缓事件的假设 在三个月大的多导睡眠图研究中，与呼吸暂停-低呼吸指数有关。这一假设 将在60名被诊断为NOWS的新生儿和60名接触阿片类药物的婴儿中进行前瞻性队列测试 对照组为60例健康对照组。