Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Study Overview
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Brief Summary
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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.

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

Conditions
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Dysphagia

Intervention / Treatment
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* Device: VitalStim
* Device: Sham VitalStim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VitalStim<br>This group will be assigned to the active VitalStim unit. | Device: VitalStim<br>* This group will receive active VitalStim treatment.<br>|
| Sham Comparator: Sham VitalStim<br>This group will be assigned to the sham VitalStim unit. | Device: Sham VitalStim<br>* This group will receive a sham VitalStim intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, neuromuscular electrical stimulation, NMES, Neonates, Vitalstim