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Ear stimulation helps babies avoid feeding tubes

NCT ID NCT04849507

Disease control Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that gently stimulates a nerve in the ear to help babies who have trouble feeding. The goal was to see if this stimulation, given during bottle feeds for 10 days, could help babies eat enough by mouth to avoid needing a feeding tube. The study included 17 infants who were at risk of getting a feeding tube. Some babies got the stimulation and some did not, and if no progress was made after 10 days, they could switch to the other group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

17 people

The number who actually took part.

Started

Aug 2022

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 weeks to 5 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm * safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and * clinical team is considering the need for a G-tube. Exclusion Criteria: * cardiomyopathy * unstable bradycardia * significant respiratory support * infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C\>5.6% or ketonuria.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant feeding problems, tavns

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States