Effect of Novel High Dissolving Transitional Foods

NYU Langone Health

Status: Invitation-only

Conditions: Craniofacial Surgery

Treatments: Dietary Supplement: High Dissolving Transitional Food

Study type: Interventional

Funder types: Other

Identifiers

NCT06522958

24-00648

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Patients randomized to the intervention group will receive a high dissolving transitional food product.

Treatment:

Dietary Supplement: High Dissolving Transitional Food

Standard of Care Group

No Intervention group

Description:

Patients randomized to the standard of care group will not receive a high dissolving transitional food product.