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

Abstract

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 significant reduction in time to discharge (-10 days, HR 1.87 (1.23, 2.84) p < 0.01). This difference was not observed in the 26–28 weeks subgroup. There was no difference in growth, mortality or morbidities between the two groups. Conclusions Patterned, frequency-modulated oro-somatosensory stimulation improves feeding development in premature infants and reduces their length of hospitalization. Trial registration ClinicalTrials.gov NCT01158391

Preterm neurodevelopmental outcomes following orosensory entrainment intervention

“…Alternatively, it may be that an earlier period of stimulation is necessary, or there may be a critical time period for such stimulation. Results from Song et al 32 indicate that orosensory entrainment provided at 31 4/7 to 32 6/7 PMA of GA resulted significant decreases on the time to full oral feeds, shorter LOS, earlier PMA at full oral feeds, and earlier PMA at hospital discharge.…”

“…Very early in development these systems may be dedicated and independent, with unknown degrees of overlap and shared characteristics as the systems develop. Future studies of orosensory entrainment may increase our understanding of these potential hypotheses, by targeting a critical time period for use of the NTrainer as noted by Song et al 32…”

“…31 The NTrainer has been found to significantly improve the dynamics of non-nutritive sucking for children born preterm with respiratory distress syndrome (RDS) and chronic lung disease (CLD) and decrease the length of hospital stay (LOS) for children born preterm who displayed CLD. 30 In a multicenter trial involving 210 preterm infants (26–30.9 weeks of chronological age [GA]), Song et al 32 found that infants randomized to receive NTrainer therapy showed a significant reduction in the number of days to full oral feeds and a significant reduction in LOS when the orosensory entrainment intervention was introduced at approximately 31.8 weeks of post menstrual age (PMA). These results provide strong support for the notion of a critical sensory period for orocutaneous stimulation to accelerate suck and oral feeding skills in preterm.…”

Automatic Nonnutritive Suck Waveform Discrimination and Feature Extraction in Preterm Infants

“…Adoption of the NTrainer is expected to double in 2019 to include new NICUs in the US and international settings. The NTrainer has been and is currently used in randomized controlled trials (RCTs) to study the neurobiology of feeding [9, 10, 30, 33].…”

Abnormal Nutritive Sucking as an Indicator of Neonatal Brain Injury

“…The logic behind the device is to stimulate the nerves involved in NNS and, thus, the CPG, in order to form a functional, effective NNS pathway using the principle “neurons that fire together, will wire together.” This therapy is effective in increasing the rates of NNS bursts, cycles, cycles per burst resulting in more daily oral feeds ( 110 , 111 ). With the NTrainer, preterm infants showed an accelerated time to oral feed and time to discharge when it was used for 20 minutes up to four times per day until full oral feeding ( 112 ); however, in longer term follow up, NTrainer therapy did not result in improvement in cognition, language or motor skills ( 113 ). While NNS does accelerate the development of preterm infants while in the NICU, it does not appear to have any long term lasting effects on further brain development.…”