Connecticut Children's Medical Center, Hartford, USA.
Brown University/Women & Infants Hospital of Rhode Island, Providence, USA.
Trials. 2023 Jul 21;24(1):466. doi: 10.1186/s13063-023-07378-x.
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.
自 2000 年以来，美国产妇阿片类药物使用的发生率大幅增加。由于孕妇在怀孕期间使用阿片类药物，2002 年至 2012 年间新生儿阿片戒断综合征（NOWS）的发病率增加了五倍。当 NOWS 迹象无法控制时，需要进行药物治疗，如果无法控制 NOWS 症状，就需要进行药物治疗，药物治疗的目的是控制 NOWS 症状。一旦开始药物治疗，婴儿的断奶策略就会有很大的差异。研究 NOWS 药物治疗断奶的一个重要理由是，断奶是药物治疗时间最长的间隔。过早停止用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实用、随机、盲法试验，旨在确定与缓慢断奶相比，快速断奶是否会减少接受吗啡或美沙酮作为治疗 NOWS 的主要药物的婴儿接受阿片类药物治疗的天数。
拟议的研究是一项实用试验，旨在确定快速断奶干预是否比缓慢断奶干预减少阿片类药物治疗的天数，并且我们为拟议的研究提供了足够的动力，以检测治疗时间长度的 2 天差异。医院将能够使用吗啡或美沙酮，并且我们可能会发现这两种药物都有积极的治疗效果，或者一种或两种药物都没有效果。
NCT04214834。2020 年 1 月 2 日注册。
