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Dysphagia | Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Dysphagia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dysphagia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:VitalStimThis group will receive active VitalStim treatment.

Device:Sham VitalStimThis group will receive a sham VitalStim intervention.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

VitalStimThis group will be assigned to the active VitalStim unit.

Sham VitalStimThis group will be assigned to the sham VitalStim unit.

Study Status

Terminated

Start Date: November 2013

Completed Date: July 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.

Secondary Outcome: Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.

Study sponsors, principal investigator, and references

Principal Investigator: Akram Khan, MD

Lead Sponsor: Sanford Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02007759

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