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Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

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. Identifier: NCT02007759
Recruitment Status : Terminated (Difficulty with recruiting patients; poor quality of EMG)
First Posted : December 11, 2013
Last Update Posted : July 18, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dysphagia Device: VitalStim Device: Sham VitalStim Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Increase the amount of formula volume taken at feedings from beginning to end of study. [ Time Frame: 2 weeks ]
  4. 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 :
  1. Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet. [ Time Frame: 2 weeks ]
  2. Decrease spells with oral feeds over the course of the study. [ Time Frame: 2 weeks ]
  3. Allow for healthy weight gain via improved feedings. [ Time Frame: 2 weeks ]
  4. Increase the caloric intake orally. [ Time Frame: 2 weeks ]
  5. Decrease the oxygen requirement before and after study. [ Time Frame: 2 weeks ]
  6. Decrease inpatient length of stay. [ Time Frame: 4 weeks ]

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

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.

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 identifier (NCT number): NCT02007759

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

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Responsible Party: Sanford Health Identifier: NCT02007759    
Other Study ID Numbers: SH NMES for Dysphagia
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: September 2016
Keywords provided by Sanford Health:
neuromuscular electrical stimulation
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases