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NCT Number: NCT06118697

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 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.

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Key information

Conditions

Feeding Disorder Neonatal

Age range

1 day–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

About this study

Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Potentially lethal chromosomal anomalies
  • Craniofacial malformations
  • Foregut malformations

Treatment and study plan

Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

Procedure

Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.

Primary outcomes

  1. Oral feeding volumes prior to and at the completion of the study

    Time frame: Collected 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

  2. Parent surveys

    Time frame: 4 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erika K Osborn

CONTACT

[email protected]

6143556667

Patty Luzader

CONTACT

[email protected]

6143556627

Sponsors and collaborators

Lead sponsor

Sudarshan Jadcherla

Other

Registry information

Official study title

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

Acronym: FAST

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 7, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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