Clinical Trial: Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Brief 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.

Detailed Summary:
Sponsor: Sanford Health

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Sanford Health

Dates:
Date Received: October 14, 2013
Date Started: November 2013
Date Completion: July 2017
Last Updated: September 19, 2016
Last Verified: September 2016