Clinical trial NCT02007759: Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Official title: Randomized Treatment of Neuromuscular Electrical Stimulation (NMES) for Dysphagia in Neonates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dysphagia
Keywords: Dysphagia
neuromuscular electrical stimulation
NMES
Neonates
Vitalstim
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 12
Sex: ALL
Minimum age (years): 36
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Reduction in G-tube rate insertions for the treatment grouped compared to the sham group.
timeFrame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
measure: Increased percent of subjects towards achieving full oral feedings earlier in the subject's dysphagia treatment.
timeFrame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
measure: Increase the amount of formula volume taken at feedings from beginning to end of study.
timeFrame: 2 weeks
measure: Earlier NG tube removal for the treatment group compared to the control group.
timeFrame: Over the course of the treatment time frame to discharge, 2 weeks to 8 weeks
Secondary outcomes:
measure: Improve swallowing skills as measured by videofluoroscopic swallowing study (VFSS) and the video swallow assessment worksheet.
timeFrame: 2 weeks
measure: Decrease spells with oral feeds over the course of the study.
timeFrame: 2 weeks
measure: Allow for healthy weight gain via improved feedings.
timeFrame: 2 weeks
measure: Increase the caloric intake orally.
timeFrame: 2 weeks
measure: Decrease the oxygen requirement before and after study.
timeFrame: 2 weeks
measure: Decrease inpatient length of stay.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Akram Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: