Feasibility of Aerodigestive Stimulation Therapy Trial

Conditions

• Feeding Disorder Neonatal

Eligibility Criteria

Sex

ALL

Age

1 Day - 8 Months

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 5, 2024

Status verified

Apr 2026

Primary completion

Nov 1, 2028

Completion

Nov 1, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Infants with Complex Feeding Difficulties
  Weekly manometric esophageal stimulation as well as consistent nutritive oral feeding therapy

Primary Outcome Measure

Oral feeding volumes prior to and at the completion of the study [ Time Frame: Collected at 4 weeks or prior to discharge ]

Central Contacts

• Erika K Osborn
  6143556667
  [email protected]
• Patty Luzader
  6143556627
  [email protected]

Locations (1)

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