Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Potentially lethal chromosomal anomalies
- Craniofacial malformations
- Foregut malformations
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
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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