Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

N/ATerminatedNCT02007759

Sanford Health12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dysphagia

Interventions

VitalStimDEVICE

This group will receive active VitalStim treatment.

Sham VitalStimDEVICE

This group will receive a sham VitalStim intervention.

Eligibility

Sex: ALLMin age: 36 WeeksMax age: 42 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 2 weeks

Earlier NG tube removal for the treatment group compared to the control group.

Time frame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks

Secondary Outcomes

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

Time frame: 2 weeks

Decrease spells with oral feeds over the course of the study.

Time frame: 2 weeks

Allow for healthy weight gain via improved feedings.

Time frame: 2 weeks

Increase the caloric intake orally.

Time frame: 2 weeks

Decrease the oxygen requirement before and after study.

Time frame: 2 weeks

Decrease inpatient length of stay.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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