Effect of Novel High Dissolving Transitional Foods
NCT Number: NCT06522958
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Craniofacial Surgery
Interventions: DIETARY_SUPPLEMENT: High Dissolving Transitional Food
Sponsor: NYU Langone Health
Sex: ALL
Age: CHILD, ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-09
Completion Date: 2027-08
Locations: NYU Langone Health, New York, New York, 10017, United States

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.

Primary Outcome Measures: 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: 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