Status:
ENROLLING_BY_INVITATION
Effect of Novel High Dissolving Transitional Foods
Lead Sponsor:
NYU Langone Health
Conditions:
Craniofacial Surgery
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
This is a prospective comparative study, where patients who meet inclusion criteria undergoing a craniofacial procedure will either be provided with novel high dissolving transitional foods for use in...
Eligibility Criteria
Inclusion
- Patients ages 0 years, 6 months to 18 years of age
- Patients with a diagnosed cleft/craniofacial condition undergoing one of the following cleft/craniofacial related surgeries in the upcoming calendar year (a-c):
- Cleft Palate Repair (Palatoplasty)
- Alveolar Bone Graft Surgery
- Velopharyngeal Insufficiency Surgery
- Patients who eat fully by mouth (PO)
- Patients who adhered to scheduling protocols and attended all necessary pre- and post-operative visits
Exclusion
- Patients under the age of 6 months or over the age of 18
- Patients who utilize an NG-tube or G-tube for primary means of nutrition/hydration
- Patients who have PO recommendations from a licensed Speech-Language Pathologist that prevents their ability to consume Level 4 IDDSI (pureed) foods, including patients who are NPO.
- Patients with any diagnosed allergies to the ingredients listed on the Savorease Therapeutic Foods ingredient labels
- Patients/caregivers who are not able to participate in pre- and post-operative protocoled visits for any reason
- Patients/caregivers who are not able to respond to written questions presented in English
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06522958
Start Date
August 9 2024
End Date
August 1 2027
Last Update
June 25 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10017