Clinical trial NCT03227627: Outcomes of Using LNMES on Tracheostomized Children
Official title: Outcomes of Using LNMES on Tracheostomized Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trachea
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy. After the 24 sessions, participants will have a repeat MBSS and results will be scored using the Pen-Asp scale and FOIS scale. Both the control group and experimental group will answer the PSI-4 after the repeat MBSS.
Primary purpose: TREATMENT

Brief summary: Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics. There is no literature available for the efficacy of LNMES in the treatment of dysphagia on patients with tracheostomy tubes. The purpose of this study to determine the outcomes on dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the investigators aim to determine the relationship between parental stress and a child's modified diet.


Eligibility criteria: Inclusion Criteria:

PATIENT COHORT

* Children between 0-4 years 11 months
* Currently have tracheostomy tubes
* MBSS must indicate penetrations of more than 50% of swallows or aspiration of thin, ½ nectar-thick, nectar-thick or honey-thick liquids.
* The child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½ nectar-thick liquids, or no liquids by mouth.
* Able to tolerate a voice valve PARENT COHORT
* At least one primary caregiver of a qualifying child (see Child cohort).
* Parent/caregiver must be at least 18 years of age or older, provide primary care, and have medical decision making rights for the child.

Exclusion Criteria:

PATIENT COHORT

* Children who are not on modified diets or using a g-tube as an alternate means of nutrition
* Children with suspected or diagnosed heart problems
* Children with suspected or diagnosed epilepsy
* Children with a tendency to hemorrhage following acute trauma or fracture
* Children who have undergone recent surgical procedures when muscle contraction may disrupt the healing process
* Children for whom the LNMES would be: 1) over carotid sinus, 2) over neoplasm, 3) over active infection and 4) over areas of skin which lack normal sensation
* Children with difficulty tolerating tactile stimulation and tolerate the whole duration of the LNMES sessions.
* Children with difficulty tolerating tactile sensory stimulation such as tape and electrodes on the anterior aspect of the neck.

PARENT COHORT

* The caregiver that does not provide the primary care of the child and does not have medical decision making right
* Parents under 18

Primary outcomes:
measure: Assess Quality of Swallow during the MBSS (Modified Barium Swallow Study) using the Pen-Asp scale.
timeFrame: 3 months. LNMES intervention will be provided for 24 sessions during this time.
measure: Assess safety and adequate functional oral intake using the FOIS (Functional Oral Intake Scale)
timeFrame: 3 months. LNMES intervention will be provided for 24 sessions during this time.
Secondary outcomes:
measure: Assess Change in Parental Stress Level using the PSI-4 (Parent Stress Index-4)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Los Angeles
name: Aviril Sepulveda
role: PRINCIPAL_INVESTIGATOR
References: