Comparative Study of the Effects of Novel High Dissolving Transitional Foods on Post-Operative Outcomes for Patients Undergoing Craniofacial Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Caregiver-Reported Rating of Feeding Experience
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group
Patients randomized to the intervention group will receive a high dissolving transitional food product.
干预措施: High Dissolving Transitional Food (Dietary Supplement)
Standard of Care Group
Patients randomized to the standard of care group will not receive a high dissolving transitional food product.
结局指标
主要结局
Caregiver-Reported Rating of Feeding Experience
时间窗: 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.
Caregiver-Reported Rating of Feeding Experience
时间窗: Week 1 Post-Operation (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.
次要结局
- Number of Participants with Wound Issues at Week 1 Post-Op(Week 1 Post-Op)
- Number of Participants with Wound Issues at Week 3 Post-Op(Week 3 Post-Op)
- Average Participant Weight at Week 3 Post-Op(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 3 Post-Op(Week 3 Post-Op)
- Average Participant Weight at Week 1 Post-Op(Week 1 Post-Op)
- 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 Pre-Op Visit(Baseline (Pre-Op Visit))
- 30-Day Readmission Rate(Day 30 Post-Op)
- Average Participant Weight at Pre-Op Visit(Baseline (Pre-Op Visit))