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New dissolvable foods could ease Post-Surgery feeding for kids

NCT ID NCT06522958

Symptom relief Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether special high-dissolving foods can improve feeding quality of life for children aged 6 months to 18 years after craniofacial surgery. Half of the 160 participants will receive these foods after surgery, while the other half will follow standard care. Researchers will survey caregivers about feeding experiences and check for wound issues at 1 and 3 weeks after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cleft lip and alveolus cleft palate congenital velopharyngeal incompetence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Craniofacial surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10017, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.