Feasibility of Aerodigestive Stimulation Therapy Trial
Recruiting now · Not applicable
Conditions studied: Feeding Disorder Neonatal
In brief
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.
Key facts
- Study ID
- NCT06118697
- Run by
- Sudarshan Jadcherla
- People needed
- 40
- Starts
- 2024-02-05
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Potentially lethal chromosomal anomalies
- Craniofacial malformations
- Foregut malformations
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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