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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Erika K Osborn
erika.osborn@nationwidechildrens.org
6143556667
Backup
Patty Luzader
patty.luzader@nationwidechildrens.org
6143556627
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 40
Treatments
Experimental: Infants with Complex Feeding Difficulties
Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy
Related Therapeutic Areas
Sponsors
Leads: Sudarshan Jadcherla

This content was sourced from clinicaltrials.gov