Actively Recruiting
Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
Led by Sudarshan Jadcherla · Updated on 2026-05-05
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new pharyngo-esophageal stimulation technique to improve swallowing and aerodigestive functions in infants at risk of needing long-term tube feeding. The study aims to show that this approach can consistently activate swallowing processes to reduce the need for home tube feeding. It also examines whether guided interventions and biofeedback improve feeding compliance, reduce parental stress, and enhance satisfaction and confidence with feeding. Infants will receive weekly esophageal stimulation using high resolution impedance manometry for up to 4 weeks or until discharge. Alongside this, they will undergo nutritive oral feeding therapy with a minimum of 5 mL of prescribed milk at each feed. Daily feeding evaluations and weekly bedside rounds will monitor progress, with feeding plans posted for clear communication with families and care teams. Participants will be involved in feeding assessments once daily during the 4-week trial period. Researchers will measure oral feeding volumes before and after the study and collect parent surveys about their experience. The study includes weekly parental education and feedback to support feeding progress. Overall participation may last up to 4 weeks or until discharge, with ongoing monitoring of feeding function and family support.
CONDITIONS
Brief Title
Feasibility of Aerodigestive Stimulation Therapy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- NICU infant at least 37 weeks postmenstrual age not taking full oral feeds
- Referred 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks or until discharge, whichever occurs first
Participants receive weekly esophageal stimulation guided by high resolution impedance manometry and nutritive oral feeding therapy with each care, starting with at least 5 mL of their prescribed feed.
Weekly visits for up to 4 weeks with daily feeding evaluations
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
E
Erika K Osborn
P
Patty Luzader
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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