Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants

Summary

Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation between gene expression, oral somatosensory stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age (CA) on 180 extremely preterm infants \[EPIs\] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA) enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St. Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral feeding skills, along with objective salivary gene expression data to monitor response to treatment and feeding development, will result in a novel, objective, and personalized approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.

Conditions

• Infant, Extremely Low Birth Weight
• Feeding Behavior

Interventions

DEVICE

NTrainer

pulsed orocutaneous stimulation paired with tube feedings

DEVICE

SHAM blind pacifier

regular green Soothie pacifier paired with tube feedings

Sponsors & Collaborators

• Tufts Medical Center

  collaborator OTHER

• CIRI/CHI Institute for Research and Innovation

  collaborator UNKNOWN

• California Institute for Medical Research

  collaborator OTHER

• Texas Tech University

  collaborator OTHER

• Children's Hospital of Orange County

  collaborator OTHER

• University of Nebraska Lincoln

  lead OTHER

Principal Investigators

• Steven M Barlow, PhD · University of Nebraska

• Jill L Maron, MD · Tufts Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-13

Primary Completion

2021-05-09

Completion

2023-03-31

Countries

• United States

Study Locations