Actively Recruiting

Phase Not Applicable
Age: 1Day - 8Months
All Genders
NCT06118697

Feasibility of Aerodigestive Stimulation Therapy Trial

Led by Sudarshan Jadcherla · Updated on 2026-05-05

40

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Feasibility of Aerodigestive Stimulation Therapy Trial

Who Can Participate

Age: 1Day - 8Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • NICU infant 63;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
Not Eligible

You will not qualify if you...

  • Potentially lethal chromosomal anomalies
  • Craniofacial malformations
  • Foregut malformations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

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Research Team

E

Erika K Osborn

CONTACT

P

Patty Luzader

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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