Clinical trial NCT01723358: Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
Official title: Effectiveness of a New Neuromuscular Electrical Stimulation (NMES) Treatment Technique (VitalStim® Therapy) in the Management of Young Infants With Severe Dysphagia: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysphagia
Keywords: pediatrics
dysphagia
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to obtain data that well help inform the feasibility and design of a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES) technique in improving the swallowing function of young infants presenting with severe dysphagia.

Detailed description: Infants with severe neurologic disability often have difficulty in eating by mouth due to a disruption in the swallowing process. This swallowing dysfunction, also known as dysphagia, is often evident early in life and when severe can be permanent. Dysphagia can lead to an inability to take in enough food to maintain an adequate weight and result in malnutrition. It also can result in food going into the lungs instead of the stomach, resulting in an illness called aspiration pneumonia. Both of these complications may require feeding by tube either through the nose into the stomach or directly into the stomach via the abdominal wall, to bypass the swallowing process. This process is resource intense, can be associated with a number of complications and may result in a reduced quality of life for both the infant and caregivers. Currently, there are no effective treatments to change the natural course of dysphagia in this context.

Eligibility criteria: Inclusion Criteria:

* Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid).
* We will include children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician.

Exclusion Criteria:

* Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections).
* Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder.

Primary outcomes:
measure: Effectiveness
timeFrame: 4 months
Secondary outcomes:
measure: Resolution of dysphagia
timeFrame: 4 months
measure: Feeding ability
timeFrame: baseline, 2 months and 4 months from enrollment
measure: Oral feeding ability and need for tube feeding
timeFrame: baseline, 2 months, 4 months from enrollment
measure: Hospitalizations for lower respiratory tract illness
timeFrame: 4 months
measure: Safety and Adverse events
timeFrame: duration of subjects involvment in the study
measure: Caregiver acceptability and perception of feeding
timeFrame: at 4 months
measure: Data on treatment procedures
timeFrame: 4 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Sanjay Mahant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marcus S, Friedman JN, Lacombe-Duncan A, Mahant S. Neuromuscular electrical stimulation for treatment of dysphagia in infants and young children with neurological impairment: a prospective pilot study. BMJ Paediatr Open. 2019 Jan 23;3(1):e000382. doi: 10.1136/bmjpo-2018-000382. eCollection 2019.