Recruiting

Aerodigestive Stimulation

Sponsor:

Sudarshan Jadcherla

Code:

NCT06118697

Conditions

Feeding Disorder Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Feeding Disorder Neonatal

Study ID

NCT06118697

Start date

Feb 5, 2024

Status verified date

Apr, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Infants with Complex Feeding Difficulties

Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Interventions

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

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 outcome measure

  • Oral feeding volumes prior to and at the completion of the study [ Time Frame: Collected at 4 weeks or prior to discharge ]
  • Parent surveys [ Time Frame: 4 weeks or prior to discharge ]

Central Contacts and Locations

Central contacts

Erika K Osborn

6143556667erika.osborn@nationwidechildrens.org

Patty Luzader

6143556627patty.luzader@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

More Information

Sponsor

Sudarshan Jadcherla

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Chronic tube feeding
  • Gastrostomy
  • Deglutition
  • Esophageal manometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sudarshan Jadcherla on 2026-05-05.