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

Status:	Recruiting
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	Any
Updated:	2/14/2019
Start Date:	April 2016
End Date:	March 2021
Contact:	Steven M Barlow, PhD
Email:	steven.barlow@unl.edu
Phone:	4024723956

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.

Inclusion Criteria:

- Extremely preterm infants (EPIs) born between 24 0/7 and 28 6/7 weeks' GA, as
determined by obstetric ultrasound at < 15 weeks or last menstrual period

- Enroll EPIs once they have a corrected PCA of ≥ 29 weeks

- Approximately equal numbers of males and females, no exclusion based on race/ethnicity

Exclusion Criteria:

- Chromosomal and congenital anomalies including craniofacial malformation, nervous
system anomalies, cyanotic congenital heart disease, gastroschisis, omphalocele,
diaphragmatic hernia and/or other major gastrointestinal anomalies

- Congenital infection

- No documented GA

- Severe IUGR (3%)

- Head circumference < 10th or > 90th percentile

- Intracranial hemorrhage grades III and IV, seizures

- Meningitis

- Neurological examination showing abnormal tone or movements of all extremities for PCA

- History of necrotizing enterocolitis (stage II and III)

- Culture-positive sepsis at the time of study enrollment

We found this trial at

sites

CHI St. Elizabeth's Medical Center

Lincoln, Nebraska 68512

Principal Investigator: Bernard J Wilson, MD

Phone: 402-219-7677

from

Lincoln, NE