NCT06118697

Feasibility of Aerodigestive Stimulation Therapy Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sudarshan Jadcherla · Academic / Other
• Sex: All
• Age: 1 Day – 8 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Feeding Disorder Neonatal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2023-11-07
• Last updated: 2024-10-04

Locations

1 site across 1 country: United States