Actively Recruiting

Phase Not Applicable
Age: 1Day - 8Months
All Genders
ID06118697

Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties

Led by Sudarshan Jadcherla · Updated on 2026-05-05

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new pharyngo-esophageal stimulation technique to improve swallowing and aerodigestive functions in infants at risk of needing long-term tube feeding. The study aims to show that this approach can consistently activate swallowing processes to reduce the need for home tube feeding. It also examines whether guided interventions and biofeedback improve feeding compliance, reduce parental stress, and enhance satisfaction and confidence with feeding. Infants will receive weekly esophageal stimulation using high resolution impedance manometry for up to 4 weeks or until discharge. Alongside this, they will undergo nutritive oral feeding therapy with a minimum of 5 mL of prescribed milk at each feed. Daily feeding evaluations and weekly bedside rounds will monitor progress, with feeding plans posted for clear communication with families and care teams. Participants will be involved in feeding assessments once daily during the 4-week trial period. Researchers will measure oral feeding volumes before and after the study and collect parent surveys about their experience. The study includes weekly parental education and feedback to support feeding progress. Overall participation may last up to 4 weeks or until discharge, with ongoing monitoring of feeding function and family support.

CONDITIONS

Brief Title

Feasibility of Aerodigestive Stimulation Therapy Trial

Who Can Participate

Age: 1Day - 8Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • NICU infant at least 37 weeks postmenstrual age not taking full oral feeds
  • Referred to Neonatal & Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
  • Presence of peristaltic and sphincteric reflexes at initial manometry
Not Eligible

You will not qualify if you...

  • Potentially lethal chromosomal anomalies
  • Craniofacial malformations
  • Foregut malformations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 weeks or until discharge, whichever occurs first

Participants receive weekly esophageal stimulation guided by high resolution impedance manometry and nutritive oral feeding therapy with each care, starting with at least 5 mL of their prescribed feed.

Weekly visits for up to 4 weeks with daily feeding evaluations

Trial Site Locations

Total: 1 location

1

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

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Research Team

E

Erika K Osborn

P

Patty Luzader

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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