Feeding Disorder Neonatal Clinical Trial
— FASTOfficial title:
Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
Verified date | November 2023 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sudarshan Jadcherla |
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 |
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