Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Not Applicable

Terminated

• Conditions: Dysphagia
• Interventions: Device: VitalStim; Device: Sham VitalStim

• Registration Number: NCT02007759
• Lead Sponsor: Sanford Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-14
• Study Start: 2013-11
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VitalStim	VitalStim	This group will be assigned to the active VitalStim unit.
Sham VitalStim	Sham VitalStim	This group will be assigned to the sham VitalStim unit.

Primary Outcome Measures

Name	Time	Method
Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.	Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Earlier NG tube removal for the treatment group compared to the control group.	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.	2 weeks
Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.	Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Decrease inpatient length of stay.	4 weeks
Decrease spells with oral feeds over the course of the study.	2 weeks
Allow for healthy weight gain via improved feedings.	2 weeks
Increase the caloric intake orally.	2 weeks
Decrease the oxygen requirement before and after study.	2 weeks
Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.	2 weeks

Trial Locations

Locations (1)

Sanford USD Medical Center; 🇺🇸 Sioux Falls, South Dakota, United States