NCT02007759

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 18, 2017

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

October 14, 2013

Last Update Submit

July 17, 2017

Conditions

Dysphagia

Keywords

Dysphagianeuromuscular electrical stimulationNMESNeonatesVitalstim

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

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

    2 weeks

  • 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 Outcomes (6)

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

    2 weeks

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

    2 weeks

  • Allow for healthy weight gain via improved feedings.

    2 weeks

  • Increase the caloric intake orally.

    2 weeks

  • Decrease the oxygen requirement before and after study.

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

VitalStim

EXPERIMENTAL

This group will be assigned to the active VitalStim unit.

Device: VitalStim

Sham VitalStim

SHAM COMPARATOR

This group will be assigned to the sham VitalStim unit.

Device: Sham VitalStim

Interventions

VitalStimDEVICE

This group will receive active VitalStim treatment.

VitalStim
Sham VitalStimDEVICE

This group will receive a sham VitalStim intervention.

Sham VitalStim

Eligibility Criteria

Age36 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Akram Khan, MD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2013

First Posted

December 11, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 18, 2017

Record last verified: 2016-09

Locations

US(1)