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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 is a NA study of Feeding Disorder Neonatal that is actively recruiting participants, run by Sudarshan Jadcherla. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06118697
The ClinicalTrials.gov registry entry for NCT06118697 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sudarshan Jadcherla, which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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