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

Completed · Not applicable · Has a placebo group

Conditions studied: Infant, Extremely Low Birth Weight, Feeding Behavior

In brief

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.

Key facts

Study ID

NCT02696343

Run by

University of Nebraska Lincoln

People needed

121

Starts

2016-07-13

Expected to finish

2023-03-31

Last updated by the study team

2026-02-27

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Orange County — Los Angeles, California, United States
• Santa Clara Valley Medical Center — San Jose, California, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• CHI St. Elizabeth's Medical Center — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.