Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02007759|
Recruitment Status : Terminated (Difficulty with recruiting patients; poor quality of EMG)
First Posted : December 11, 2013
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Device: VitalStim Device: Sham VitalStim||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
This group will be assigned to the active VitalStim unit.
This group will receive active VitalStim treatment.
Sham Comparator: Sham VitalStim
This group will be assigned to the sham VitalStim unit.
Device: Sham VitalStim
This group will receive a sham VitalStim intervention.
- Reduction in G-tube rate insertions for the treatment grouped compared to the sham group. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 2 weeks ]
- Earlier NG tube removal for the treatment group compared to the control group. [ Time Frame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks ]
- Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet. [ Time Frame: 2 weeks ]
- Decrease spells with oral feeds over the course of the study. [ Time Frame: 2 weeks ]
- Allow for healthy weight gain via improved feedings. [ Time Frame: 2 weeks ]
- Increase the caloric intake orally. [ Time Frame: 2 weeks ]
- Decrease the oxygen requirement before and after study. [ Time Frame: 2 weeks ]
- Decrease inpatient length of stay. [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007759
|United States, South Dakota|
|Sanford USD Medical Center|
|Sioux Falls, South Dakota, United States, 57117|
|Principal Investigator:||Akram Khan, MD||Sanford Health|