Effect of Novel High Dissolving Transitional Foods

N/AEnrolling By InvitationNCT06522958

NYU Langone Health160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

160

Conditions

Craniofacial Surgery

Interventions

High Dissolving Transitional FoodDIETARY_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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 1 Post-Operation (Post-Op)

Caregiver-Reported Rating of Feeding Experience

Time frame: Week 3 Post-Op

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Week 3 Post-Op

30-Day Readmission Rate

Data from ClinicalTrials.gov

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