Craniofacial SurgeryNCT06522958
Effect of Novel High Dissolving Transitional Foods
A study testing High Dissolving Transitional Food in people with Craniofacial Surgery, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Craniofacial Surgery
- What is being tested?
- High Dissolving Transitional Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of the Effects of Novel High Dissolving Transitional Foods on Post-Operative Outcomes for Patients Undergoing Craniofacial Surgery
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.
- Conditions
- Craniofacial Surgery
- Being tested
- High Dissolving Transitional Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients randomized to the intervention group will receive a high dissolving transitional food product. Receives: Dietary Supplement: High Dissolving Transitional Food |
| Standard of Care Group | No intervention | Patients randomized to the standard of care group will not receive a high dissolving transitional food product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 3 Post-Op
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: Week 3 Post-Op
30-Day Readmission Rate
Percentage of participants who are readmitted to the hospital within 30 days post-operation.
Measured: Day 30 Post-Op
Average Participant Weight at Pre-Op Visit
Participant weight is measured in pounds (lbs).
Measured: Baseline (Pre-Op Visit)
Average Participant Weight at Week 1 Post-Op
Participant weight is measured in pounds (lbs).
Measured: Week 1 Post-Op
Average Participant Weight at Week 3 Post-Op
Participant weight is measured in pounds (lbs).
Measured: Week 3 Post-Op
Number of Participants who Self-Report Use of Pain Medicine at Pre-Op Visit
Measured: Baseline (Pre-Op Visit)
Number of Participants who Self-Reported Use of Pain Medicine at Week 1 Post-Op
Measured: Week 1 Post-Op
Number of Participants who Self-Reported Use of Pain Medicine at Week 3 Post-Op
Measured: Week 3 Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start9 Aug 2024
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial SurgeryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Flores, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522958
- Sponsor's protocol ID
- 24-00648
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Margaret.lico@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.