Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty with recruiting patients; poor quality of EMG
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VitalStim | Experimental | This group will be assigned to the active VitalStim unit. |
|
| Sham VitalStim | Sham Comparator | This group will be assigned to the sham VitalStim unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitalStim | Device | This group will receive active VitalStim treatment. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in G-tube rate insertions for the treatment grouped compared to the sham group. | Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks | |
| Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment. | Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks | |
| Increase the amount of formula volume taken at feedings from beginning to end of study. | 2 weeks | |
| Earlier NG tube removal for the treatment group compared to the control group. | Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet. | 2 weeks | |
| Decrease spells with oral feeds over the course of the study. | 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Akram Khan, MD | Sanford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | United States |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham VitalStim |
| Device |
This group will receive a sham VitalStim intervention. |
|
| Allow for healthy weight gain via improved feedings. | 2 weeks |
| Increase the caloric intake orally. | 2 weeks |
| Decrease the oxygen requirement before and after study. | 2 weeks |
| Decrease inpatient length of stay. | 4 weeks |
| D010038 | Otorhinolaryngologic Diseases |