Feasibility of Aerodigestive Stimulation Therapy Trial

Description

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 Overview

Study Details

Study overview

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.

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

Feasibility of Aerodigestive Stimulation Therapy Trial

Condition
Feeding Disorder Neonatal
Intervention / Treatment

-

Contacts and Locations

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Potentially lethal chromosomal anomalies
  • * Craniofacial malformations
  • * Foregut malformations

Ages Eligible for Study

1 Day to 8 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sudarshan Jadcherla,

Sudarshan Jadcherla, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

2027-11-01