Feasibility of Aerodigestive Stimulation Therapy Trial (FAST)

Sudarshan Jadcherla

Status: Enrolling

Conditions: Feeding Disorder Neonatal

Treatments: Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06118697

STUDY00000804

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 day to 8 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Infants with Complex Feeding Difficulties

Experimental group

Description:

Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Treatment:

Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy