RECRUITING

Feasibility of Aerodigestive Stimulation Therapy Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-05
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06118697

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.

Ages Eligible for Study:1 Day to 8 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
  2. * Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
  3. * Presence of peristaltic and sphincteric reflexes at initial manometry
  1. * Potentially lethal chromosomal anomalies
  2. * Craniofacial malformations
  3. * Foregut malformations

Contacts and Locations

Study Contact

Erika K Osborn
CONTACT
6143556667
erika.osborn@nationwidechildrens.org
Patty Luzader
CONTACT
6143556627
patty.luzader@nationwidechildrens.org

Principal Investigator

Sudarshan Jadcherla
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sudarshan Jadcherla

  • Sudarshan Jadcherla, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

  • Chronic tube feeding
  • Gastrostomy
  • Deglutition
  • Esophageal manometry

Additional Relevant MeSH Terms

  • Feeding Disorder Neonatal