Feasibility of Aerodigestive Stimulation Therapy Trial (FAST)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Feeding Disorder Neonatal
• Intervention / Treatment: Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sudarshan Jadcherla

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Deglutition; Esophageal manometry; Gastrostomy; Chronic tube feeding
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: STUDY00000804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will revisit at a later date

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No