Status:
RECRUITING
Feasibility of Aerodigestive Stimulation Therapy Trial
Lead Sponsor:
Sudarshan Jadcherla
Conditions:
Feeding Disorder Neonatal
Eligibility:
All Genders
1-8 years
Phase:
NA
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...
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 enro...
Eligibility Criteria
Inclusion
- 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
- Potentially lethal chromosomal anomalies
- Craniofacial malformations
- Foregut malformations
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06118697
Start Date
February 5 2024
End Date
November 1 2027
Last Update
October 4 2024
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205