Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial.

An alternate approach, symptom-based dosing, may better align treatment with withdrawal severity.

另一种方法，基于症状的剂量调整，可能更好地使治疗与戒断的严重程度相匹配。

Background

To compare time from birth to medical readiness for discharge for infants with moderate to severe withdrawal treated with either a symptom-based dosing or scheduled opioid taper approach.

比较接受基于症状剂量或计划性阿片类药物递减治疗的中度至重度戒断婴儿从出生到出院准备就绪的时间。

DESIGN, SETTING, AND PARTICIPANTS: In this cluster, crossover randomized clinical trial with run-in period, 23 US hospitals cared for infants using the Eat, Sleep, Console approach (ESC) or Finnegan-based care (a comprehensive scoring system to quantify severity of symptoms; 15 ESC and 8 Finnegan hospitals) and their preferred primary opioid.

设计、设置和参与者：在这项群组交叉随机临床试验中，有23家美国医院采用“吃、睡、安慰”方法（ESC）或基于Finnegan的护理（一种全面评分系统，用于量化症状的严重程度；15家ESC和8家Finnegan医院），并使用他们首选的主要阿片类药物。

Opioid dosing was guided by study-approved, site-specific algorithms.

阿片类药物剂量的指导依据是研究批准的、特定于各研究地点的算法。

Infants with NOWS with a gestational age at birth of at least 36 weeks and at risk for pharmacologic treatment were enrolled between March 25, 2024, and April 9, 2025, with the last 3-month assessment on July 15, 2025.

2024年3月25日至2025年4月9日期间，对至少36周胎龄且有药物治疗风险的新生儿戒断综合症(NOWS)婴儿进行了登记，最后一次3个月的评估在2025年7月15日进行。

Sample size analyses were conducted between August 1, 2024, and September 23, 2024.

样本量分析于2024年8月1日至2024年9月23日之间进行。

intervention

Sites were randomized to 1 of 2 sequences: (1) symptom-based dosing followed by scheduled opioid taper or (2) scheduled opioid taper followed by symptom-based dosing.

研究地点被随机分配到两种序列之一：（1）基于症状的剂量调整后进行计划性的阿片类药物减量，或（2）计划性的阿片类药物减量后进行基于症状的剂量调整。

main_outcome_and_measure

Time from birth to medical readiness for discharge.

从出生到出院准备就绪的时间。

Results

Of the 626 enrolled infants (mean [SD] gestational age, 38 [1] weeks; 49% male), 383 were cared for with ESC (primary outcome cohort).

在纳入的626名婴儿中（平均[标准差]胎龄为38[1]周；49%为男性），有383名婴儿接受了ESC治疗（主要结果队列）。

The mean time to medical readiness for discharge was significantly shorter in the symptom-based dosing group compared with the scheduled opioid taper group (9.18 vs 11.61 days; adjusted mean ratio [aMR], 0.79 [95% CI, 0.65-0.96]).

基于症状的剂量组的出院医疗准备平均时间显著短于计划性阿片类药物递减组（9.18天对比11.61天；调整后平均比率[aMR]，0.79 [95% 置信区间，0.65-0.96]）。

There was no difference in the risk for initiation of pharmacologic treatment (0.4 vs 0.41; adjusted risk ratio, 0.99 [95% CI, 0.77-1.27]) or length of stay (10.91 vs 12.09 days; aMR, 0.9 [95% CI, 0.72-1.13]) between groups.

两组在启动药物治疗的风险（0.4对比0.41；调整后风险比率，0.99 [95% 置信区间，0.77-1.27]）或住院时长（10.91天对比12.09天；aMR，0.9 [95% 置信区间，0.72-1.13]）上没有差异。

For infants in the symptom-based group, 35% (95% CI, 25%-45%) required scheduled opioid dosing due to withdrawal severity that was not controlled with intermittent dosing.

在基于症状的组别中，35%（95%置信区间，25%-45%）的婴儿因无法通过间歇性给药控制的撤药严重程度而需要计划性的阿片类药物剂量。

In the Finnegan cohort (n = 243; planned secondary outcome), there were no significant differences in time to medical readiness for discharge (15.99 vs 17.56 days; aMR, 0.91 [95% CI, 0.72-1.15]) or length of stay (17.38 vs 19.39 days; aMR, 0.9 [95% CI, 0.69-1.16]).

在Finnegan队列（n = 243；计划的次要结果）中，出院医疗准备时间（15.99天对比17.56天；调整平均比率，0.91 [95%置信区间，0.72-1.15]）或住院时长（17.38天对比19.39天；调整平均比率，0.9 [95%置信区间，0.69-1.16]）没有显著差异。

The inpatient composite safety outcome occurred rarely (in the ESC cohort, 3 of 188 in the symptom-based dosing vs 2 of 195 in the scheduled opioid taper groups).

住院综合安全结果很少发生（在ESC队列中，症状为基础的剂量组有3例，计划性阿片类药物减量组有2例）。

conclusions_and_relevance

Symptom-based dosing decreased time to medical readiness for discharge compared with a scheduled opioid taper approach among infants cared for with ESC.

与计划性阿片类药物减量方法相比，基于症状的剂量减少了婴儿使用ESC护理的出院准备时间。

trial_registration

ClinicalTrials.gov Identifier: NCT05980260.

临床试验注册号：NCT05980260。