Condition: Feeding Disorder Neonatal · Sponsor: Sudarshan Jadcherla
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.
This description comes directly from the study's public registry record.
Erika K Osborn · 6143556667 · erika.osborn@nationwidechildrens.org
Patty Luzader · 6143556627 · patty.luzader@nationwidechildrens.org
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| Nationwide Children's Hospital | Columbus, Ohio, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06118697