Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:7/19/2017
Start Date:November 2013
End Date:July 2016

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

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.


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.
We found this trial at
1
site
Sioux Falls, South Dakota 57117
?
mi
from
Sioux Falls, SD
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