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โ† Trials
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Feasibility of Aerodigestive Stimulation Therapy Trial

RecruitingNAAges 1 Day - 8 MonthsAllSudarshan Jadcherla
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In plain words

What the trial is, and whether it could suit you

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, a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * NICU infant โ‰ฅ37 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
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What it tests

  • Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
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Where

1 site
Nationwide Children's Hospital
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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