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Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

This study has been terminated.
(Difficulty with recruiting patients; poor quality of EMG)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02007759
First Posted: December 11, 2013
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanford Health
  Purpose
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.

Condition Intervention
Dysphagia Device: VitalStim Device: Sham VitalStim

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Resource links provided by NLM:


Further study details as provided by Sanford Health:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: November 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007759


Locations
United States, South Dakota
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Sanford Health
Investigators
Principal Investigator: Akram Khan, MD Sanford Health
  More Information

Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT02007759     History of Changes
Other Study ID Numbers: SH NMES for Dysphagia
First Submitted: October 14, 2013
First Posted: December 11, 2013
Last Update Posted: July 18, 2017
Last Verified: September 2016

Keywords provided by Sanford Health:
Dysphagia
neuromuscular electrical stimulation
NMES
Neonates
Vitalstim

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases