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NCT06522958

Effect of Novel High Dissolving Transitional Foods

Enrolling by Invitation
NAAges 6–18InterventionalSupportive care
NYU Langone Health
~160 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:High Dissolving Transitional Food

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Caregiver-Reported Rating of Feeding Experience
Measured over Week 1 Post-Operation (Post-Op)
+1 more outcome measured

Conditions

Craniofacial Surgery

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Roberto Flores, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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):
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

What this trial measures

  • Caregiver-Reported Rating of Feeding ExperienceWeek 1 Post-Operation (Post-Op)

    Caregivers of participants will complete short survey to assess patient's feeding-related quality of life (QOL) related to the post-operative period. The survey comprises 10 items; each item utilizes a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). The total score is the sum of responses and ranges from 0-40; lower scores indicate greater feeding-related QOL.

  • Caregiver-Reported Rating of Feeding ExperienceWeek 3 Post-Op

    Caregivers of participants will complete short survey to assess patient's feeding-related quality of life (QOL) related to the post-operative period. The survey comprises 10 items; each item utilizes a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). The total score is the sum of responses and ranges from 0-40; lower scores indicate greater feeding-related QOL.