Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Stopped early · Not applicable · Has a placebo group

Conditions studied: Dysphagia

In brief

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.

Key facts

Study ID

NCT02007759

Run by

Sanford Health

People needed

12

Starts

2013-11-01

Expected to finish

2016-07-01

Last updated by the study team

2017-07-18

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sanford USD Medical Center — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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