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

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date July 18, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Official Title  ICMJE Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dysphagia
Intervention  ICMJE
  • Device: VitalStim
    This group will receive active VitalStim treatment.
  • Device: Sham VitalStim
    This group will receive a sham VitalStim intervention.
Study Arms  ICMJE
  • Experimental: VitalStim
    This group will be assigned to the active VitalStim unit.
    Intervention: Device: VitalStim
  • Sham Comparator: Sham VitalStim
    This group will be assigned to the sham VitalStim unit.
    Intervention: Device: Sham VitalStim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2013)
50
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Weeks to 42 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02007759
Other Study ID Numbers  ICMJE SH NMES for Dysphagia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanford Health
Study Sponsor  ICMJE Sanford Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Akram Khan, MD Sanford Health
PRS Account Sanford Health
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP