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Tailored Pre-Surgery care may improve outcomes for babies with cleft lip and palate

NCT ID NCT07687537

Knowledge-focused Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study looks at different presurgical treatments for infants born with cleft lip and palate. These treatments help shape the mouth and nose before surgery. Researchers will compare how well each approach works, how many clinic visits are needed, and how much burden it places on families. The goal is to find the best individualized care plan for each baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors choose the best presurgical treatment for each infant, leading to better alignment and symmetry before surgery.
What could go wrong
This is an observational study, not a controlled trial, so it may not prove which treatment is best. Results depend on routine care and family circumstances.

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.

Participants

About 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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.

Who is studied

Infants diagnosed with cleft lip and palate who receive presurgical infant orthopedic (PSIO) treatment at the Pediatric Dentistry, University of Florida. Participants will be enrolled prospectively during routine clinical care. Treatment approaches are selected by the treating clinicians based on each infant's clinical presentation and family circumstances rather than by the study protocol. Clinical outcome data will be collected prospectively during routine clinical care and follow-up visits.

Ages

1 day to 12 months

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 1. Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment 2. Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair 3. Parent or guardian ability to provide consent 4. Willingness to comply with follow up visits to the extent feasible given family circumstances Exclusion Criteria 1. Other craniofacial syndromes requiring a substantially different management protocol 2. Anticipated inability to complete any follow up 3. Lack of parental consent

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip/palate

As listed by the trial registrant

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

Cleft lip and palate

How to take part

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

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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