Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysphagia
- Sponsor
- Sanford Health
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female.
- •Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.
- •Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.
- •Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.
- •Multiple swallows to clear bolus following suck that includes a desaturation \<80% and bradycardia \<80 bpm.
- •Apnea spells during feeds.
- •Aspiration or penetration by VFSS
Exclusion Criteria
- •Known neurologic or neurodegenerative disorders.
- •Chromosomal anomalies and syndromes.
- •Cleft lip or palate.
- •Birth defects.
- •Unresolved cutaneous rash at the area of electrode placement.
- •Medical condition that is a contraindication to NMES.
Outcomes
Primary Outcomes
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
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
Increase the amount of formula volume taken at feedings from beginning to end of study.
Time Frame: 2 weeks
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
Secondary Outcomes
- Decrease inpatient length of stay.(4 weeks)
- Decrease spells with oral feeds over the course of the study.(2 weeks)
- 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)
- Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.(2 weeks)