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Feasibility of Aerodigestive Stimulation Therapy Trial

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

Who can join

1 Day – 8 Months · All sexes

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

About the study

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.

What is being tested

• Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy (procedure)

Sponsor: Sudarshan Jadcherla · Participants: 40 · Started: Feb 5, 2024

Contact the study team

• Erika K Osborn · Phone: 6143556667
• Patty Luzader · Phone: 6143556627

Official record on ClinicalTrials.gov — NCT06118697

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.