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NCT06118697 · ClinicalTrials.gov registry record · NA
Feasibility of Aerodigestive Stimulation Therapy Trial
A NA study of Feeding Disorder Neonatal, sponsored by Sudarshan Jadcherla.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06118697: Recruiting NA study of Feeding Disorder Neonatal, sponsored by Sudarshan Jadcherla.
NCT06118697 is a NA study of Feeding Disorder Neonatal that is actively recruiting participants, run by Sudarshan Jadcherla. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06118697, a NA study of Feeding Disorder Neonatal, is actively recruiting participants, sponsored by Sudarshan Jadcherla.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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-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.
Primary Outcome
Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest
Conditions Studied
Interventions
- PROCEDURE Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-02-05 |
| Est. Completion | 2027-11-01 |
| Phase | NA |
What NCT06118697 shows while recruiting
NCT06118697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Feeding Disorder Neonatal appearing as the primary indexed condition, and to 1 intervention - of which Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy is the first listed.
NCT06118697 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06118697 about?
NCT06118697 is a clinical study titled "Feasibility of Aerodigestive Stimulation Therapy Trial". 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 ac...
What is the current status of trial NCT06118697?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-02-05. Estimated completion is 2027-11-01.
What conditions does trial NCT06118697 study?
This clinical trial studies the following conditions: Feeding Disorder Neonatal.
What interventions are being tested in trial NCT06118697?
The interventions under investigation include: Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy (PROCEDURE).
Who is sponsoring clinical trial NCT06118697?
This trial is sponsored by Sudarshan Jadcherla, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06118697 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06118697's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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