The NTrainer System is an FDA-cleared evidence-based device backed by clinical, NIH and case study research


March 2017: Standardized Patterned Somatosensory Oral Stimulation in Very
Preterm Infants: A Multicenter Randomized Controlled Trial

  • Patterned and frequency-modulated oral somatosensory stimulation is safe and more effective than regular pacifier in promoting feeding development in very preterm infants.
  • It enables very preterm infants to achieve the milestone of independent oral feeding at 35 weeks PMA, comparable to the time course of normal development in an in utero environment.
  • It significantly shortens length of NICU stay, allows early reunion of infants with their families, minimizes the risk of potential iatrogenic complications, and decreases medical costs.
  • The therapeutic effect was only observed in the more mature subgroup, possibly demonstrating a gestationally-dependent period for targeting acquisition of oral feeding skills
  • A better understanding of how gestational age, chronological age and clinical status interact with the critical period of oral feeding development can further improve our ability to effectively utilize feeding entrainment in clinical practice.
  • The impact of these beneficial effects on long-term feeding behavior and neurodevelopmental outcome remains to be studied.

March 2017: Growth and Oral Feeding Evaluation of Infants Who Received Patterned Oral Somatosensory Stimulation in NICU

  • At NICU discharge anthropometric measurements were not significantly different between the control and experimental groups.
  • At 4-12 month CGA the NTrainer group had a significant larger median length percentile compared to the control group. The difference persisted into 18-30 months CGA, however it was no longer statistically significant.
  • At first HRIF visit and pediatric visit, compared to the control group, the Ntrainer group had better weight gain and head growth but the differences were not statistically significant.
  • Our follow-up study shows that the NTrainer therapy had no negative impact on growth and feeding abilities after NICU discharge.
  • NTrainer therapy may potentially improve growth after discharge. This finding needs to be validated by followup data from the entire study cohort.
  • The impact of NTrainer therapy on long-term neurodevelopment remains to be studied.
NTrainer Growth and Oral Feeding Evaluation 2017 (Image).jpg

March 2017: Shorter NICU Length of Stay does not increase Risk of Readmission in Very Preterm Infants

  • Very preterm infants in our center are discharged 6 days earlier than other regional NICUs in California.
  • Six percent of these infants are readmitted within 30 days after being discharged to home. This is similar to the California preterm readmission rate described by Lorch et al.
  • Three infants were electively readmitted for inguinal hernia surgery and one infant was readmitted for social reasons.
  • In our center we are reassured that the risk of readmission is not associated with shorter LOS.

May 2016: Standardized Patterned Somatosensory Oral Stimulation in Very
Preterm Infants: A Multicenter Randomized Controlled Trial

Abstract: 

Background: Very preterm infants have delayed establishment of full oral feeding (FOF), a rate-limiting step for discharge.

Objective: To evaluate the effect of standardized patterned somatosensory oral stimulation on transition to FOF and on length of stay (LOS) in very preterm infants.

Design/Methods: A multicenter randomized controlled trial (RCT) was conducted in 5 centers from 2011 - 2015. Infants born between 26 0/7 and 30 6/7 weeks of gestational age (GA) were enrolled, randomized, and stratified by GA. The experimental group received programmed patterned somatosensory oral stimulation delivered by a pneumatically charged pulsatile pacifier (NTrainer®, Innara Health, KS) and the sham group received a non-pulsatile pacifier. Interventions were performed x 3-4 daily during tube feeding for 10-14 days beginning at 30 0/7-32 6/7 weeks post menstrual age (PMA). Oral feeding was initiated as early as 32 0/7 weeks PMA and advanced based on a standardized feeding protocol. The median days to and PMA at FOF and median LOS between the groups were compared using the Mann-Whitney rank sum test. The mean days to FOF, LOS, PMA at FOF and PMA at discharge were compared using t-test.

Poster Presentation, Pediatric Academic Society, 2016 - Poster 1

Poster Presentation, Pediatric Academic Society, 2016 - Poster 2


June 2015: Implementation of the NTrainer System into Clinical Practice Targeting Neurodevelopment of Pre-oral Skills and Parental Involvement

Abstract: The initiation of early oral motor assessments by neonatal occupational therapists (OT) and the implementation of an NTrainer system to help facilitate feeding progression in the premature infant population was incorporated into practice by the Ohio State University Wexner Medical Center (OSUWMC) who partnered with Nationwide Children’s Hospital, Columbus, Ohio. OSUWMC did not have a set protocol to use with infants prior to beginning oral feeds and studies have found that providing oral motor stimulation in a consistent manner accelerates transition time to oral feeds. Anecdotally, through observation, repeated experience and data recorded by the NTrainer, the NICU team as a whole noted that infants who received early oral motor assessments by the neonatal OT and NTrainer therapy demonstrated a more mature NNS pattern, improved suck strength, and a decreased hypersensitivity to oral motor intervention, overall positively affecting the neurodevelopment of the preterm infant. These combined therapies also resulted in the development of a standard feeding guideline that begins at 29 weeks gestational age (GA).

Newborn & Infant Nursing Reviews Volume 15, Issue 2, Pages 46-48


February 2014: The NTrainer System (referred to as Frequency-modulated orocutaneous stimulation) promotes non-nutritive suck development in preterm infants with respiratory distress syndrome or chronic lung disease

Conclusion: (NTrainer System) Frequency-modulated PULSED orocutaneous pulse train stimuli delivered through a silicone pacifier are effective in facilitating NNS burst development in tube-fed RDS and CLD preterm infants, with an added benefit of reduced LOS for CLD infants.

For the premature infant, extrauterine life is a pathological condition, which greatly amplifies the challenges to the brain in establishing functional oromotor behaviors. The extent to which suck can be entrained using a synthetically patterned orocutaneous input to promote its development in preterm infants who manifest chronic lung disease (CLD) is unknown. The objective of this study was to evaluate the effects of a frequency-modulated (FM) orocutaneous pulse train delivered through a pneumatically charged pacifier capable of enhancing non-nutritive suck (NNS) activity in tube-fed premature infants.

Journal of Perinatology 34, 136-142


June 2010: Feeding Skills in the Preterm Infant

Conclusion: Repeated exposure to (NTrainer System) patterned orocutaneous concurrent with NG tube feeds facilitates the development and presumably strengthens neural networks that regulate suck. Entrainment therapy provides the infant with additional benefits, including improved behavioral state control pre- and post-feed, growth, maturation, and gastric motility, while decreasing stress and enhancing the transition to oral feeds. 

ASHA.org


November 2009: Prospective Study of Non-nutritive Sucking and Feeding Skills in Premature Infants

Conclusion: Measures of NNS organization and suck consistency constitute useful candidate predictors of feeding performance by premature infants. The results accord with previous findings linking PMA at birth with age at independent feeding.

Arch. Dis Child Fetal Neonatal Ed. 2010 May;95(3):F194-200. doi: 10.1136/adc.2009.164186. Epub. 2009 Nov 29: Bingham PM, Ashikaga T, Abbasi S.

Pubmed.com


December 2008: Non-Nutritive Suck Therapeutic Device for Premature Infants 

Conclusion: Tube-fed preterm infants with respiratory distress syndrome who were treated with a therapeutic device rapidly learned to suck far better and transitioned to oral feeding faster than a control group of babies with the syndrome.

Researchers compared 20 tube-fed preterm infants who had moderate to severe respiratory distress syndrome and were treated with the NTrainer to a control group of age-matched infants who had respiratory distress syndrome and received a sham consisting of a non-instrumented pacifier during tube feedings.

Infants in the study who received the patterned NTrainer treatment exhibited a near doubling of non-nutritive suck burst complexity, a 50 percent to 100 percent increase on select suck burst production measures, and a tripling of their average daily oral feed levels to 72.8 percent compared to the untreated controls (23 percent).

Advance Healthcare Network for Speech and Hearing