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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 is a NA study that has completed, run by University of Nebraska Lincoln. The registered enrollment target is 121 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02696343
The ClinicalTrials.gov registry entry for NCT02696343 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska Lincoln, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NTrainer is the first listed.
NCT02696343 reports 0 study locations.
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.
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