Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS).
Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS).
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作者：
自2000年以来，美国母体使用阿片类药物的发生率大幅增加。由于妊娠期间使用阿片类药物，新生儿阿片类药物戒断综合征（NOWS）的发病率在2002年至2012年期间增加了五倍。当NOWS体征无法控制时，需要进行药物治疗，药物治疗的目的是控制NOWS体征。一旦开始药物治疗，婴儿断奶的策略有很大的差异。研究NOWS药物治疗撤机的一个重要依据是，撤机代表药物治疗的最长时间间隔。过早停药可能无法完全治疗NOWS症状。这将是一项关于阿片类药物断奶的务实、随机、设盲试验，以确定与缓慢断奶相比，更快的断奶是否会减少接受吗啡或美沙酮作为NOWS主要治疗的婴儿的阿片类药物治疗天数。拟议的研究是一项务实的试验，以确定与缓慢断奶干预相比，快速断奶干预是否减少了阿片类药物治疗的天数，我们为拟议的研究提供了动力，以检测治疗时间的2天差异。医院将能够使用吗啡或美沙酮的知识，我们可能会发现一个积极的治疗效果，两种药物，一种，或都没有。NCT 04214834。2020年1月2日注册。在线版本包含补充材料，可通过10.1186/s13063-023-07378-x获得。
The incidence of maternal opioid use in the USA has increased substantially since 2000. As a consequence of opioid use during pregnancy, the incidence of neonatal opioid withdrawal syndrome (NOWS) has increased fivefold between 2002 and 2012. Pharmacological therapy is indicated when signs of NOWS cannot be controlled, and the objective of pharmacological therapy is to control NOWS signs. Once pharmacologic therapy has started, there is great variability in strategies to wean infants. An important rationale for studying weaning of pharmacological treatment for NOWS is that weaning represents the longest time interval of drug treatment. Stopping medications too early may not completely treat NOWS symptoms. This will be a pragmatic, randomized, blinded trial of opioid weaning to determine whether more rapid weaning, compared to slow wean, will reduce the number of days of opioid treatment in infants receiving morphine or methadone as the primary treatment for NOWS. The proposed study is a pragmatic trial to determine whether a rapid-weaning intervention reduces the number of days of opioid treatment, compared to a slow-weaning intervention, and we powered the proposed study to detect a 2-day difference in the length of treatment. Hospitals will be able to use either morphine or methadone with the knowledge that we may find a positive treatment effect for both, one, or neither drugs. NCT04214834. Registered January 2, 2020. The online version contains supplementary material available at 10.1186/s13063-023-07378-x.
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影响因子：
2.9
作者：
Brown, M. S.;Hayes, M. J.;Thornton, L. M.
通讯作者：
Thornton, L. M.
影响因子：
3.5
作者：
Gibbons, Laura E.;Feldman, Betsy J.;Crane, Heidi M.;Mugavero, Michael;Willig, James H.;Patrick, Donald;Schumacher, Joseph;Saag, Michael;Kitahata, Mari M.;Crane, Paul K.
通讯作者：
Crane, Paul K.
影响因子：
158.5
作者：
Kraft, Walter K.;Adeniyi-Jones, Susan C.;Ehrlich, Michelle E.
通讯作者：
Ehrlich, Michelle E.
DOI：
10.1038/s41372-018-0088-9
发表时间：
2018-05
期刊：
Journal of perinatology : official journal of the California Perinatal Association
影响因子：
--
作者：
Merhar SL;McAllister JM;Wedig-Stevie KE;Klein AC;Meinzen-Derr J;Poindexter BB
通讯作者：
Poindexter BB
DOI：
10.1136/adc.2003.033555
发表时间：
2004-07-01
影响因子：
4.4
作者：
Jackson, L;Ting, A;Skeoch, C
通讯作者：
Skeoch, C