Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

July 17, 2017 updated by: Sanford Health

Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford USD Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VitalStim
This group will be assigned to the active VitalStim unit.
Device: VitalStim
This group will receive active VitalStim treatment.
SHAM_COMPARATOR: Sham VitalStim
This group will be assigned to the sham VitalStim unit.
Device: Sham VitalStim
This group will receive a sham VitalStim intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Akram Khan, MD, Sanford Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH NMES for Dysphagia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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