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Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates

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Sanford Health

Status

Terminated

Conditions

Dysphagia

Treatments

Device: VitalStim
Device: Sham VitalStim

Study type

Interventional

Funder types

Other

Identifiers

NCT02007759
SH NMES for Dysphagia

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

36 to 42 weeks old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

12 participants in 2 patient groups

VitalStim
Experimental group
Description:
This group will be assigned to the active VitalStim unit.
Treatment:
Device: VitalStim
Sham VitalStim
Sham Comparator group
Description:
This group will be assigned to the sham VitalStim unit.
Treatment:
Device: Sham VitalStim

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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