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NCT02696343 · ClinicalTrials.gov registry record · NA
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
A NA study, sponsored by University of Nebraska Lincoln.
- Completed
- Registry status
- NA
- Development phase
- 121
- Enrollment target
NCT02696343: Completed NA study, sponsored by University of Nebraska Lincoln.
NCT02696343 is a NA study that has completed, run by University of Nebraska Lincoln. The registered enrollment target is 121 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02696343, a NA study, has completed, sponsored by University of Nebraska Lincoln.
- COMPLETED
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
Study 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.
Primary Outcome
RT PCR gene expression profiles for CDH13 (Cadherin 13, a protein Coding gene), FOXP2 (encodes a member of the forkhead/winged-helix (FOX) family of transcription factors), NPHP4 (Nephronophthisis 4), NPY2R (Neuropeptide Y2 receptor), PLXNA1 (involved in several processes, including generation of neurons; regulation of GTPase activity; and regulation of cell shape), and Wingless-type integration site family (WNT3). Data presented here represent the median values and interquartile range, combined
Interventions
- DEVICE NTrainer
- DEVICE SHAM blind pacifier
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2016-07-13 |
| Est. Completion | 2023-03-31 |
| Phase | NA |
What the finished NCT02696343 record still lists
NCT02696343 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which NTrainer is the first listed.
NCT02696343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02696343 about?
NCT02696343 is a clinical study titled "Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants". 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, ...
What is the current status of trial NCT02696343?
This trial is currently completed. It is a NA study. The enrollment target is 121 participants. The study started on 2016-07-13. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT02696343?
The interventions under investigation include: NTrainer (DEVICE), SHAM blind pacifier (DEVICE).
Who is sponsoring clinical trial NCT02696343?
This trial is sponsored by University of Nebraska Lincoln, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02696343's enrollment target sits among peer trials
121 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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