Dysphagia
Conditions
Keywords
Dysphagia, neuromuscular electrical stimulation, NMES, Neonates, Vitalstim
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.
Interventions
DEVICEVitalStim
This group will receive active VitalStim treatment.
DEVICESham VitalStim
This group will receive a sham VitalStim intervention.
Sponsors
Sanford Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
36 Weeks to 42 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Decrease the oxygen requirement before and after study. | 2 weeks |
| Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet. | 2 weeks |
| Decrease inpatient length of stay. | 4 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 |
Countries
United States
Outcome results
None listed