Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118697
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-26
Brief Title:
Feasibility of Aerodigestive Stimulation Therapy Trial
Sponsor:
Sudarshan Jadcherla
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST
Brief 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
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None