Trial record 11 of 217 for:    Open Studies | "Deglutition Disorders"

Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sanford Health
Sponsor:
Information provided by (Responsible Party):
M. Akram Khan, Sanford Health
ClinicalTrials.gov Identifier:
NCT02007759
First received: October 14, 2013
Last updated: December 5, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Increase the amount of formula volume taken at feedings from beginning to end of study. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Decrease spells with oral feeds over the course of the study. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Allow for healthy weight gain via improved feedings. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Increase the caloric intake orally. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Decrease the oxygen requirement before and after study. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Decrease inpatient length of stay. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   36 Weeks to 42 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007759

Contacts
Contact: Jeremy P Morgan, MS 605-328-1398 jeremy.morgan@sanfordhealth.org
Contact: Diane Hahn 605-328-1361 diane.hahn@sanfordhealth.org

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

No publications provided

Responsible Party: M. Akram Khan, Neonatologist, Sanford Health
ClinicalTrials.gov Identifier: NCT02007759     History of Changes
Other Study ID Numbers: SH NMES for Dysphagia
Study First Received: October 14, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014