RecruitingNot ApplicableNCT06118697

Feasibility of Aerodigestive Stimulation Therapy Trial

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


Sponsor

Sudarshan Jadcherla

Enrollment

40 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 DayMax Age: 8 Months

Inclusion Criteria3

  • 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 Criteria3

  • Potentially lethal chromosomal anomalies
  • Craniofacial malformations
  • Foregut malformations

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Interventions

PROCEDUREEsophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy

Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.


Locations(1)

Nationwide Children's Hospital

Columbus, Ohio, United States

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NCT06118697


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