Objective To evaluate the effects of direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS) on oral feeding ability in very preterm infants. Design Blinded, parallel group, randomised controlled trial (1:1:1). Setting Neonatal intensive care unit of a South Korean tertiary hospital. Participants Preterm infants born at <32 weeks of gestation who achieved full tube feeding. Interventions Two sessions per day were provided according to the randomly assigned groups (control: two times per day sham intervention; DST: DST and sham interventions, each once a day; DST+OSMS: DST and OSMS interventions, each once a day). Primary outcome Time from start to independent oral feeding (IOF). Results Analyses were conducted in 186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS). The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02). Compared with non-intervention, DST+OSMS significantly shortened the time from start to IOF (effect size: −0.49; 95% CI: −0.86 to –0.14; p=0.02), whereas DST did not. The proportion of feeding volume taken during the initial 5 min, an index of infants’ actual feeding ability when fatigue is minimal, increased earlier in the DST+OSMS than in the DST. Conclusions In very preterm infants, DST+OSMS led to the accelerated attainment of IOF compared with non-intervention, whereas DST alone did not. The effect of DST+OSMS on oral feeding ability appeared earlier than that of DST alone. Trial registration number ClinicalTrials.gov Registry ([NCT02508571][1]). Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to kimek@snu.ac.kr. [1]: http://NCT02508571

中文翻译：

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早产儿的直接吞咽训练和口腔感觉运动刺激：一项随机对照试验

目的评价单独直接吞咽训练（DST）和联合口腔感觉运动刺激（OSMS）对极早产儿经口喂养能力的影响。设计 盲法、平行组、随机对照试验 (1:1:1)。设置韩国三级医院新生儿重症监护室。参与者 孕周<32 周出生并实现全管喂养的早产儿。干预 根据随机分配的组每天提供两次会议（对照组：每天两次假干预；DST：DST 和假干预，每天一次；DST+OSMS：DST 和 OSMS 干预，每天一次）。主要结果 从开始到独立经口喂养 (IOF) 的时间。结果根据改良的意向治疗（63 名对照；63 名 DST；60 名 DST+OSMS）对 186 名参与者进行了分析。从开始到 IOF 的平均时间在对照组、DST 和 DST+OSMS 组之间有显着差异（分别为 21.1、17.2 和 14.8 天，p=0.02）。与不干预相比，DST+OSMS 显着缩短了从开始到 IOF 的时间（效应大小：-0.49；95% CI：-0.86 至 –0.14；p=0.02），而 DST 没有。在最初的 5 分钟内采取的喂养量比例是婴儿在疲劳最小时的实际喂养能力的指数，在 DST+OSMS 中比在 DST 中更早地增加。结论在极早产儿中，与不干预相比，DST+OSMS 导致 IOF 的加速实现，而单独的 DST 则没有。DST+OSMS对经口摄食能力的影响比单独使用DST更早出现。试验注册号 ClinicalTrials.gov Registry ([NCT02508571][1])。可根据合理要求提供数据。除研究方案、统计分析计划和知情同意书外，还将提供去识别的个人参与者数据（包括数据字典）。这些数据将在发布后提供给研究人员，这些研究人员提供了一个方法上合理的提案，用于实现批准提案的目标。提案应提交至 kimek@snu.ac.kr。[1]：http://NCT02508571