Effect of Novel High Dissolving Transitional Foods

Conditions

• Craniofacial Surgery

Eligibility Criteria

Sex

ALL

Age

6 Months - 18 Years

Healthy Volunteers

Not accepted

Interventions

• High Dissolving Transitional Food — DIETARY_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 Details

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.

Key Dates

Start date

Aug 9, 2024

Status verified

Apr 2026

Primary completion

Feb 28, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Intervention Group
  Patients randomized to the intervention group will receive a high dissolving transitional food product.
• No Intervention: Standard of Care Group
  Patients randomized to the standard of care group will not receive a high dissolving transitional food product.

Primary Outcome Measure

Caregiver-Reported Rating of Feeding Experience [ Time Frame: Week 1 Post-Operation (Post-Op) ]

Locations (1)

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