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Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Primary Purpose

Dysphagia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VitalStim

Sham VitalStim

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, neuromuscular electrical stimulation, NMES, Neonates, Vitalstim

Eligibility Criteria

36 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanford USD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

VitalStim

Sham VitalStim

Arm Description

This group will be assigned to the active VitalStim unit.

This group will be assigned to the sham VitalStim unit.

Outcomes

Primary Outcome Measures

Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.

Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.

Increase the amount of formula volume taken at feedings from beginning to end of study.

Earlier NG tube removal for the treatment group compared to the control group.

Secondary Outcome Measures

Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.

Decrease spells with oral feeds over the course of the study.

Allow for healthy weight gain via improved feedings.

Increase the caloric intake orally.

Decrease the oxygen requirement before and after study.

Decrease inpatient length of stay.

Full Information

NCT ID

NCT02007759

First Posted

October 14, 2013

Last Updated

July 17, 2017

Sponsor

Sanford Health

1. Study Identification

Unique Protocol Identification Number

NCT02007759

Brief Title

Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Difficulty with recruiting patients; poor quality of EMG

Study Start Date

November 2013 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanford Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysphagia

Keywords

Dysphagia, neuromuscular electrical stimulation, NMES, Neonates, Vitalstim

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VitalStim

Arm Type

Experimental

Arm Description

This group will be assigned to the active VitalStim unit.

Arm Title

Sham VitalStim

Arm Type

Sham Comparator

Arm Description

This group will be assigned to the sham VitalStim unit.

Intervention Type

Device

Intervention Name(s)

VitalStim

Intervention Description

This group will receive active VitalStim treatment.

Intervention Type

Device

Intervention Name(s)

Sham VitalStim

Intervention Description

This group will receive a sham VitalStim intervention.

Primary Outcome Measure Information:

Title

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

Title

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

Title

Increase the amount of formula volume taken at feedings from beginning to end of study.

Time Frame

2 weeks

Title

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 Measure Information:

Title

Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.

Time Frame

2 weeks

Title

Decrease spells with oral feeds over the course of the study.

Time Frame

2 weeks

Title

Allow for healthy weight gain via improved feedings.

Time Frame

2 weeks

Title

Increase the caloric intake orally.

Time Frame

2 weeks

Title

Decrease the oxygen requirement before and after study.

Time Frame

2 weeks

Title

Decrease inpatient length of stay.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

36 Weeks

Maximum Age & Unit of Time

42 Weeks

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akram Khan, MD

Organizational Affiliation

Sanford Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanford USD Medical Center

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57117

Country

United States

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

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