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

PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Enteral Nutrition / instrumentation
  • Enteral Nutrition / methods*
  • Feeding Behavior / physiology*
  • Female
  • Humans
  • Infant, Extremely Premature / physiology*
  • Infant, Newborn
  • Male
  • Pacifiers
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01158391
  • Dryad/10.5061/dryad.rg57q6m

Grants and funding

This study was sponsored by Innara Health Inc., Olathe, Kansas, United States, http://www.innarahealth.com/. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.