Clinical trial NCT06118697: Feasibility of Aerodigestive Stimulation Therapy Trial
Official title: Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding Disorder Neonatal
Keywords: Chronic tube feeding
Gastrostomy
Deglutition
Esophageal manometry
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mechanistic study design
Primary purpose: TREATMENT

Brief summary: The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:

* To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.
* To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.

Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.

Detailed description: Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.

Eligibility criteria: Inclusion Criteria:

* NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
* Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
* Presence of peristaltic and sphincteric reflexes at initial manometry

Exclusion Criteria:

* Potentially lethal chromosomal anomalies
* Craniofacial malformations
* Foregut malformations

Primary outcomes:
measure: Oral feeding volumes prior to and at the completion of the study
timeFrame: Collected at 4 weeks or prior to discharge
measure: Parent surveys
timeFrame: 4 weeks or prior to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sudarshan Jadcherla
role: PRINCIPAL_INVESTIGATOR
References: