Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 36 Weeks to 42 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
VitalStim
This group will be assigned to the active VitalStim unit.
Intervention: VitalStim (Device)
Sham VitalStim
This group will be assigned to the sham VitalStim unit.
Intervention: Sham VitalStim (Device)
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
- Increase the caloric intake orally.(2 weeks)
- 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)
- 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)