Feasibility of Aerodigestive Stimulation Therapy Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2027-11-01

Brief Summary

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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.

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Detailed Description

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Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.

Conditions

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Feeding Disorder Neonatal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mechanistic study design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infants with Complex Feeding Difficulties

Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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Esophageal 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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