Effect of Novel High Dissolving Transitional Foods

NCT06522958 | Enrolling By Invitation

• 1 other identifier: 24-00648
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Number of Participants with Wound Issues at Pre-Op Visit

  Baseline (Pre-Op Visit)

• Number of Participants with Wound Issues at Week 1 Post-Op

  Week 1 Post-Op

• Number of Participants with Wound Issues at Week 3 Post-Op

  Week 3 Post-Op

• 30-Day Readmission Rate

  Day 30 Post-Op

• Average Participant Weight at Pre-Op Visit

  Baseline (Pre-Op Visit)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Dietary Supplement: High Dissolving Transitional Food

Standard of Care Group

NO INTERVENTION

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

Interventions

High Dissolving Transitional Food 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.

Intervention Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

Location

Study Officials

• Roberto Flores, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 26, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)