N/A
Completed N=121
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Infant, Extremely Low Birth Weight · Feeding Behavior
Source: ClinicalTrials.gov NCT02696343 ↗
Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Salivary Gene Expression — 21.344; 21.420; 20.931; 21.100 Delta-CT — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Salivary Gene Expression |
21.344; 21.420; 20.931; 21.100; 11.879; 11.844 | <0.01 sig |
| SECONDARY NNS Bursts/Minute |
5.72; 5.98; 5.71; 5.21 | <0.05 sig |
| SECONDARY Time-to-transition to Full Oral Feed |
17.40; 12.79; 15.24; 7.13 | <0.05 sig |
| SECONDARY NNS Cycles/Min |
54.56; 53.70; 55.89; 50.30 | <0.05 sig |
| SECONDARY Non-nutritive Suck Spatiotemporal Index (NNS STI) |
63.84; 65.16; 65.97; 67.62 | <0.05 sig |
| SECONDARY Non-nutritive Suck Compression Amplitude (cmH2O) |
28.41; 27.87; 29.03; 22.68 | <0.05 sig |
| SECONDARY National Institute Child Human Development (NICHD) Neonatal Research Network Feed-growth Questionnaire |
8; 3; 11; 5; 4; 3 | <0.05 sig |
| SECONDARY Bayley III Developmental Scales-Cognition |
91.53; 91.41; 88.06; 86.23 | 0.7989 |
| SECONDARY Bayley III Developmental Scales-Language |
86.22; 88.95; 83.73; 85.50 | 0.8979 |
| SECONDARY Bayley III Developmental Scales-Motor |
90.95; 96.41; 89.89; 85.30 | 0.1085 |
Eligibility Criteria
Inclusion Criteria
- Extremely preterm infants (EPIs) born between 24 0/7 and 28 6/7 weeks' GA, as determined by obstetric ultrasound at 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
Data sourced from ClinicalTrials.gov (NCT02696343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.