Clinical trial NCT06522958: Effect of Novel High Dissolving Transitional Foods
Official title: Comparative Study of the Effects of Novel High Dissolving Transitional Foods on Post-Operative Outcomes for Patients Undergoing Craniofacial Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Craniofacial Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Caregiver-Reported Rating of Feeding Experience
timeFrame: Week 1 Post-Operation (Post-Op)
measure: Caregiver-Reported Rating of Feeding Experience
timeFrame: Week 3 Post-Op
Secondary outcomes:
measure: Number of Participants with Wound Issues at Pre-Op Visit
timeFrame: Baseline (Pre-Op Visit)
measure: Number of Participants with Wound Issues at Week 1 Post-Op
timeFrame: Week 1 Post-Op
measure: Number of Participants with Wound Issues at Week 3 Post-Op
timeFrame: Week 3 Post-Op
measure: 30-Day Readmission Rate
timeFrame: Day 30 Post-Op
measure: Average Participant Weight at Pre-Op Visit
timeFrame: Baseline (Pre-Op Visit)
measure: Average Participant Weight at Week 1 Post-Op
timeFrame: Week 1 Post-Op
measure: Average Participant Weight at Week 3 Post-Op
timeFrame: Week 3 Post-Op
measure: Number of Participants who Self-Report Use of Pain Medicine at Pre-Op Visit
timeFrame: Baseline (Pre-Op Visit)
measure: Number of Participants who Self-Reported Use of Pain Medicine at Week 1 Post-Op
timeFrame: Week 1 Post-Op
measure: Number of Participants who Self-Reported Use of Pain Medicine at Week 3 Post-Op
timeFrame: Week 3 Post-Op
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Roberto Flores, MD
role: PRINCIPAL_INVESTIGATOR
References: