Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial.

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).