FAST: Feasibility of Aerodigestive Stimulation Therapy Trial
Study Details
Study Description
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:
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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.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Infants with Complex Feeding Difficulties 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
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.
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Outcome Measures
Primary Outcome Measures
- Oral feeding volumes prior to and at the completion of the study [Collected at 4 weeks or prior to discharge]
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
- Parent surveys [4 weeks or prior to discharge]
Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
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Consult to Neonatal & Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
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Presence of peristaltic and sphincteric reflexes at initial manometry
Exclusion Criteria:
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Potentially lethal chromosomal anomalies
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Craniofacial malformations
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Foregut malformations
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sudarshan Jadcherla
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00000804