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Feasibility of Aerodigestive Stimulation Therapy for Neonatal Feeding Disorders

This study is looking at a new way to help infants with feeding difficulties. It's called "Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy." This treatment involves gently stimulating the esophagus (the tube that carries food from the mouth to the stomach) using a special tool, along with giving small amounts of food by mouth. The goal is to see if this can help babies learn to swallow better and reduce the need for feeding tubes. We're looking for infants between 1 day and 8 months old who are in the NICU, are at least 37 weeks old, and have feeding difficulties. We want to see if this treatment helps them eat more by mouth and if parents feel less stressed and more confident about feeding their baby. This study plans to enroll 40 infants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 40 participants.
What's involved
Participants will receive esophageal stimulation weekly for 4 weeks or until discharge. They will also receive nutritive oral feeding therapy with each feeding, and a study team member will evaluate feeding once a day.
Compensation
Not stated in the trial record.
Follow-up
Oral feeding volumes and parent surveys will be collected at 4 weeks or prior to discharge.

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NCT06118697

Feasibility of Aerodigestive Stimulation Therapy Trial

Recruiting
NAAges 1–8InterventionalTreatment
Sudarshan Jadcherla
~40 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oral feeding volumes prior to and at the completion of the study
Measured over Collected at 4 weeks or prior to discharge
+1 more outcome measured

Conditions

Feeding Disorder Neonatal

Explore related trials

DysphagiaFeeding Disorders

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Sudarshan Jadcherla · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Erika K Osborn
[email protected]
6143556667
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Oral feeding volumes prior to and at the completion of the studyCollected at 4 weeks or prior to discharge

    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

  • Parent surveys4 weeks or prior to discharge

    Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.