Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02007759
• Other study ID #: SH NMES for Dysphagia
• Status: Terminated
• Phase: N/A
• First received: October 14, 2013
• Last updated: July 17, 2017
• Start date: November 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Weeks to 42 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• VitalStim
This group will receive active VitalStim treatment.
• Sham VitalStim
This group will receive a sham VitalStim intervention.

Locations

Country	Name	City	State
United States	Sanford USD Medical Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.		Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Primary	Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.		Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Primary	Increase the amount of formula volume taken at feedings from beginning to end of study.		2 weeks
Primary	Earlier NG tube removal for the treatment group compared to the control group.		Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Secondary	Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.		2 weeks
Secondary	Decrease spells with oral feeds over the course of the study.		2 weeks
Secondary	Allow for healthy weight gain via improved feedings.		2 weeks
Secondary	Increase the caloric intake orally.		2 weeks
Secondary	Decrease the oxygen requirement before and after study.		2 weeks
Secondary	Decrease inpatient length of stay.		4 weeks