NCT06522958

Effect of Novel High Dissolving Transitional Foods

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Craniofacial Surgery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2024-08-09
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2024-07-26
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States