Feasibility of Aerodigestive Stimulation Therapy Trial

Not Applicable

Recruiting

• Conditions: Feeding Disorder Neonatal
• Interventions: Procedure: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

• Registration Number: NCT06118697
• Lead Sponsor: Sudarshan Jadcherla

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:

* 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.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Study Start: 2024-02-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infants with Complex Feeding Difficulties	Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy	Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States