Trials / Terminated
TerminatedNCT02007759
Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Sanford Health · Academic / Other
- Sex
- All
- Age
- 36 Weeks – 42 Weeks
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate if the use of Neuromuscular Electrical Stimulation (NMES) will provide a more efficient method of treating neonates with dysfunctional oral feeding such as dysphagia. This study will attempt to determine if NMES applied to neonates at 36-42 weeks post-conception age (PCA) will decrease the need for nasogastric tubes (NG) and gastrostomy tubes (G-TUBE). Increase the rate at which these neonates complete full oral feeds, improve their swallowing skills, increase oral intake of calories, and gain weight.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VitalStim | This group will receive active VitalStim treatment. |
| DEVICE | Sham VitalStim | This group will receive a sham VitalStim intervention. |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2013-12-11
- Last updated
- 2017-07-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02007759. Inclusion in this directory is not an endorsement.