Effect of Novel High Dissolving Transitional Foods

Not Applicable

• Conditions: Craniofacial Surgery
• Interventions: Dietary Supplement: High Dissolving Transitional Food

• Registration Number: NCT06522958
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-26
• Study Start: 2024-08-09
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	High Dissolving Transitional Food	Patients randomized to the intervention group will receive a high dissolving transitional food product.

Primary Outcome Measures

Name	Time	Method
Caregiver-Reported Rating of Feeding Experience	Week 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States