Effect of Novel High Dissolving Transitional Foods

NCT ID: NCT06522958

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2027-08-31

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 the post-operative period (Intervention Group) or will not be provided the food and will proceed as per current standard of care (Standard of Care Group). Both groups will be followed pre-operatively at time of pre-operative visit, and will be followed in the post-operative period, with two visits at 1 and 3 weeks post-operatively, respectively.

Conditions

Craniofacial Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

Patients randomized to the intervention group will receive a high dissolving transitional food product.

Group Type: EXPERIMENTAL

High Dissolving Transitional Food

Intervention Type: DIETARY_SUPPLEMENT

Transitional foods are solid foods that rapidly change texture in the presence of moisture (e.g., water or saliva) or temperature change. Duration of consumption of the investigational agent will include the time of the surgery until the second post-operative evaluation. This is estimated to be approximately 1-2 months in total.

Standard of Care Group

Patients randomized to the standard of care group will not receive a high dissolving transitional food product.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High Dissolving Transitional Food

Transitional foods are solid foods that rapidly change texture in the presence of moisture (e.g., water or saliva) or temperature change. Duration of consumption of the investigational agent will include the time of the surgery until the second post-operative evaluation. This is estimated to be approximately 1-2 months in total.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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):

1. Cleft Palate Repair (Palatoplasty)

2. Alveolar Bone Graft Surgery

3. 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 Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Flores, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

24-00648

Identifier Type: -

Identifier Source: org_study_id