Feasibility of Aerodigestive Stimulation Therapy Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties

Conditions
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Feeding Disorder Neonatal

Intervention / Treatment
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* Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Mechanistic study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infants with Complex Feeding Difficulties<br>Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy | Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy<br>* Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral feeding volumes prior to and at the completion of the study | Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest | Collected at 4 weeks or prior to discharge | 
| Parent surveys | Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study. | 4 weeks or prior to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic tube feeding, Gastrostomy, Deglutition, Esophageal manometry