Effect of Novel High Dissolving Transitional Foods

Официальное название

Comparative Study of the Effects of Novel High Dissolving Transitional Foods on Post-Operative Outcomes for Patients Undergoing Craniofacial Surgery

Обзор

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.

Вмешательства

• Пищевая добавка High Dissolving Transitional Food
  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.

Первичные конечные точки

• Caregiver-Reported Rating of Feeding Experience [Срок оценки: Week 1 Post-Operation (Post-Op)]
• Caregiver-Reported Rating of Feeding Experience [Срок оценки: Week 3 Post-Op]

Вторичные конечные точки (10)

• Number of Participants with Wound Issues at Pre-Op Visit [Срок оценки: Baseline (Pre-Op Visit)]
• Number of Participants with Wound Issues at Week 1 Post-Op [Срок оценки: Week 1 Post-Op]
• Number of Participants with Wound Issues at Week 3 Post-Op [Срок оценки: Week 3 Post-Op]
• 30-Day Readmission Rate [Срок оценки: Day 30 Post-Op]
• Average Participant Weight at Pre-Op Visit [Срок оценки: Baseline (Pre-Op Visit)]
• Average Participant Weight at Week 1 Post-Op [Срок оценки: Week 1 Post-Op]
• Average Participant Weight at Week 3 Post-Op [Срок оценки: Week 3 Post-Op]
• Number of Participants who Self-Report Use of Pain Medicine at Pre-Op Visit [Срок оценки: Baseline (Pre-Op Visit)]
• Number of Participants who Self-Reported Use of Pain Medicine at Week 1 Post-Op [Срок оценки: Week 1 Post-Op]
• Number of Participants who Self-Reported Use of Pain Medicine at Week 3 Post-Op [Срок оценки: Week 3 Post-Op]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06522958 · 24-00648

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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