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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with Complex Feeding Difficulties | Experimental | Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy | Procedure | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erika K Osborn | Contact | 6143556667 | erika.osborn@nationwidechildrens.org | |
| Patty Luzader | Contact | 6143556627 | patty.luzader@nationwidechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Sudarshan Jadcherla | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
will revisit at a later date
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Mechanistic study design
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