Patterned frequency-modulated oral stimulation in preterm infants: a multicenter randomized controlled trial

Objective To evaluate the effect of patterned, frequency-modulated oro-somatosensory stimulation on time to full oral feeds in preterm infants born 26 - 30 weeks gestation. Study Design This is a multicenter randomized controlled trial. The experimental group (n = 109) received patterned, frequency-modulated oral stimulation via the NTrainer system through a pulsatile pacifier and the control group (n = 101) received a non-pulsatile pacifier. Intent-to-treat analysis (n = 210) was performed to compare the experimental and control groups and the outcomes were analyzed using generalized estimating equations. Time-to-event analyses for time to reach full oral feeds and length of hospital stay were conducted using Cox proportional hazards models. Results The experimental group had reduction in time to full oral feeds compared to the control group (-4.1 days, HR 1.37 (1.03, 1.82) p = 0.03). In the 29-30 weeks subgroup, infants in the experimental group had a...研究目的 评估模式化频率调节口体感刺激对胎龄26~30周早产婴儿达到完全经口喂养所需时间的影响。 研究设计 本研究为多中心随机对照试验。实验组（n=109）通过NTrainer系统，借助脉动奶嘴实施模式化频率调节的口腔刺激；对照组（n=101）使用非脉动奶嘴。本研究采用意向性治疗分析（Intent-to-treat analysis，n=210）比较两组受试者的结局，结局指标采用广义估计方程（generalized estimating equations）进行分析；同时采用Cox比例风险模型（Cox proportional hazards models）对达到完全经口喂养的时间以及住院时长开展时间-事件分析。 研究结果 实验组达到完全经口喂养所需时间较对照组显著缩短，较对照组减少4.1天，风险比HR=1.37，95%置信区间为[1.03, 1.82]，p=0.03。在胎龄29~30周亚组中，实验组婴儿……