Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Sanford Health

Status: Terminated

Conditions: Dysphagia

Treatments: Device: VitalStim; Device: Sham VitalStim

Study type: Interventional

Funder types: Other

Identifiers

NCT02007759

SH NMES for Dysphagia

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 36 to 42 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

VitalStim

Experimental group

Description:

This group will be assigned to the active VitalStim unit.

Treatment:

Device: VitalStim

Sham VitalStim

Sham Comparator group

Description:

This group will be assigned to the sham VitalStim unit.

Treatment:

Device: Sham VitalStim