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Testing the Reliability and Validity of Pupil Diameter in Opioid-exposed neonates

测试阿片类药物暴露新生儿瞳孔直径的可靠性和有效性

基本信息

批准号：
8699737
负责人：
Sarah H Heil
金额：
$ 41.81万
依托单位：
UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-15 至 2017-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8699737
关键词：
Adult Caliber Clinical Clinical Research Data Detection Development Digital Photography Dose Effectiveness Eye Family Health Care Costs Heroin Hour Human Infant Length of Stay Literature Measurement Measures Methadone Methods Morbidity - disease rate Neonatal Neonatal Abstinence Syndrome Opiate Addiction Opiates Opioid Outcome Measure Patient Self-Report Perinatal Exposure Pharmaceutical Preparations Pharmacodynamics Pharmacological Treatment Pharmacotherapy Photography Physical Dependence Postpartum Women Protocols documentation Pupil Relative (related person)Research Risk Severities Substance-Related Disorders Sum Testing Therapeutic Intervention Time Training Validation Validity and Reliability Vulnerable Populations Weaning Withdrawal cost improved in utero indexing innovation instrument meetings named group neonate opioid withdrawal pregnant response therapy development tool

项目摘要

DESCRIPTION (provided by applicant): Pupil diameter is one of the most frequently assessed objective indices of the pharmacodynamic effects of opioids in humans. The pupillary effects of opioids are easily measured photographically in adults and are a highly sensitive measure of the presence and extent of physical dependence and withdrawal. Measures of pupillary response are often collected along with self-reported and observer-rated effects to provide a comprehensive profile of opioid effects. Infants exposed to opioids in utero are born physically dependent and often suffer from withdrawal (i.e., neonatal abstinence syndrome~ NAS) that is severe enough to require pharmacological treatment. Observer- rated scales are the only tools available to evaluate the need for and effectiveness of pharmacological treatment for NAS in both clinical and research settings and shortcomings of these instruments (e.g., rudimentary validation, long training and administration times) have led to calls for more sensitive, objective measures of NAS. We have developed a protocol to measure pupil diameter in opioid-exposed neonates. Pilot data (N=10) using this protocol indicate neonatal pupils respond to opioids in the same manner as adults and suggest that pupil diameter may be a more sensitive measure of NAS compared to observer-rated scales. Thus, the next step is to fully test the reliability and validity of pupil diameter in opioid-exposed neonates. Two studies are proposed to meet this overarching aim. The first study will formally test the reliability of ou pupil photography protocol in 40 opioid-exposed neonates. The second study will test the validity of pupillary changes in neonates as an index of opioid effects using the extensive adult literature on the pupillary effects of opioids as a guide. One-hundred ten opioid-exposed neonates and 30 non-exposed neonates will provide data for four analyses of validity. First, pupil diameter measurements collected over the first 24 hours after delivery will be examined to see if they discriminate between opioid-exposed and non-exposed neonates, testing discriminant validity. Second, among the opioid-exposed neonates, correlations between changes in pupil diameter and changes in observer-rated NAS scale scores over the first 24 hours after delivery will be examined, testing concurrent validity. Third, opioid tolerance and the time course of pupillary effects after opioid administration will be examined among the opioid-exposed neonates who require pharmacological treatment (estimated n= 35), testing construct validity. The fourth and final analysis will examine predictive validity by testing whether changes in pupil diameter in the first 24 hours after delivery predicts which neonates went on to receive pharmacological treatment. In sum, establishing the reliability and validit of pupil diameter in opioid-exposed neonates has potential to substantially improve assessment and treatment of opioid-exposed neonates in both clinical and research settings, reducing morbidity, shortening hospital stays, and decreasing costs.

描述（由申请人提供）：瞳孔直径是阿片类药物对人类药效作用最常评估的客观指标之一。阿片类药物的瞳孔效应很容易在成人中通过照相测量，并且是对身体依赖和戒断的存在和程度的高度敏感的测量。瞳孔反应的测量通常与自我报告和观察者评价的效果一起收集，以提供阿片类药物效果的全面概况。在子宫内接触阿片类药物的婴儿出生时就会产生身体依赖性，并且经常会出现戒断症状（即新生儿戒断综合征~NAS），严重程度需要药物治疗。观察员评定量表是评估药物治疗的必要性和有效性的唯一工具 NAS 在临床和研究环境中的应用以及这些仪器的缺点（例如，基本验证、训练和管理时间长）导致人们呼吁对 NAS 进行更灵敏、客观的测量。我们开发了一种测量阿片类药物暴露新生儿瞳孔直径的方案。使用该方案的试点数据 (N=10) 表明新生儿学生对阿片类药物的反应与成人相同，并表明与观察者评级量表相比，瞳孔直径可能是 NAS 更敏感的测量方法。因此，下一步是全面测试阿片类药物暴露新生儿瞳孔直径的可靠性和有效性。 Two studies 为实现这一总体目标而提出的建议。第一项研究将在 40 名暴露于阿片类药物的新生儿中正式测试 ou 瞳孔摄影方案的可靠性。第二项研究将使用有关阿片类药物瞳孔效应的大量成人文献作为指导，测试新生儿瞳孔变化作为阿片类药物效应指标的有效性。 100 名接触过阿片类药物的新生儿和 30 名未接触过阿片类药物的新生儿将为四项有效性分析提供数据。首先，将检查分娩后 24 小时内收集的瞳孔直径测量值，看看它们是否能够区分暴露于阿片类药物和未暴露于阿片类药物的新生儿，并测试区分有效性。其次，在暴露于阿片类药物的新生儿中，将检查产后 24 小时内瞳孔直径变化与观察者评定的 NAS 量表评分变化之间的相关性，以测试同时有效性。第三，阿片类药物耐受性和将在需要药物治疗的阿片类药物暴露新生儿（估计 n = 35）中检查阿片类药物给药后瞳孔效应的时间过程，测试结构有效性。第四项也是最后一项分析将通过测试分娩后 24 小时内瞳孔直径的变化是否可以预测哪些新生儿继续接受药物治疗来检验预测的有效性。总之，确定阿片类药物暴露新生儿瞳孔直径的可靠性和有效性有可能在临床和研究环境中显着改善阿片类药物暴露新生儿的评估和治疗，降低发病率，缩短住院时间并降低成本。