Feasibility of Aerodigestive Stimulation Therapy Trial

Feeding Disorder Neonatal Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118697
• Other study ID #: STUDY00000804
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 8 Months

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder Neonatal

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sudarshan Jadcherla

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral feeding volumes prior to and at the completion of the study	Oral feeding volume will be compared prior to the initial manometry study and after the completion of the final manometry study after 4 weeks or prior to discharge, whichever is earliest	Collected at 4 weeks or prior to discharge
Primary	Parent surveys	Parental questionnaires will be compared from prior to initial esophageal manometry study and after completion of final esophageal manometry study.	4 weeks or prior to discharge