Effect of Novel High Dissolving Transitional Foods

Comparative Study of the Effects of Novel High Dissolving Transitional Foods on Post-Operative Outcomes for Patients Undergoing Craniofacial Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Craniofacial Surgery
• Intervention / Treatment: Dietary supplement: High Dissolving Transitional Food

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Patients randomized to the intervention group will receive a high dissolving transitional food product.	Dietary supplement: 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.
No Intervention: Standard of Care Group; Patients randomized to the standard of care group will not receive a high dissolving transitional food product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver-Reported Rating of Feeding Experience	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.	Week 1 Post-Operation (Post-Op)
Caregiver-Reported Rating of Feeding Experience	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.	Week 3 Post-Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Wound Issues at Pre-Op Visit	Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications.	Baseline (Pre-Op Visit)
Number of Participants with Wound Issues at Week 1 Post-Op	Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications.	Week 1 Post-Op
Number of Participants with Wound Issues at Week 3 Post-Op	Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications.	Week 3 Post-Op
30-Day Readmission Rate	Percentage of participants who are readmitted to the hospital within 30 days post-operation.	Day 30 Post-Op
Average Participant Weight at Pre-Op Visit	Participant weight is measured in pounds (lbs).	Baseline (Pre-Op Visit)
Average Participant Weight at Week 1 Post-Op	Participant weight is measured in pounds (lbs).	Week 1 Post-Op
Average Participant Weight at Week 3 Post-Op	Participant weight is measured in pounds (lbs).	Week 3 Post-Op
Number of Participants who Self-Report Use of Pain Medicine at Pre-Op Visit		Baseline (Pre-Op Visit)
Number of Participants who Self-Reported Use of Pain Medicine at Week 1 Post-Op		Week 1 Post-Op
Number of Participants who Self-Reported Use of Pain Medicine at Week 3 Post-Op		Week 3 Post-Op

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Roberto Flores, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-00648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Margaret.lico@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Margaret.lico@nyulangone.org . To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No