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Cleft care network aims to boost outcomes by sharing data

NCT ID NCT02702869

Knowledge-focused Sponsor: Duke University 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 brings together medical teams that treat children with cleft lip and/or palate. They will collect information on speech, hearing, dental health, and quality of life from about 1,000 patients. The goal is to compare results across centers and find ways to improve care. No new treatments or medications are being tested.

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 1,000 people

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

Started

Oct 2016

Expected to finish

Dec 2031

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

All patients born with cleft lip and/or palate are eligible for inclusion in this study.

Ages

1 day to 22 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: * Typical orofacial clefts, of which subtypes are: * Unilateral or bilateral cleft lip * Unilateral or bilateral cleft lip and alveolus * Unilateral or bilateral cleft lip and alveolus and palate * Unilateral or bilateral cleft lip and palate * Overt cleft palate * Occult cleft palate Exclusion Criteria: * Atypical (Tessier) facial clefts

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip and alveolus cleft lip/palate cleft palate submucosal cleft palate

As listed by the trial registrant

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

Cleft lip Cleft lip and palate Cleft palate

How to take part

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

  1. The places running it

    11 sites in 2 countries. 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

  • Dalhousie University - IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Duke University - Duke Children's Hospital & Health Center

    Durham, North Carolina, 27710, United States

  • Harvard University - Boston Children's Hospital (BCH)

    Boston, Massachusetts, 02115, United States

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021, United States

  • Johns Hopkins - All Children's Hospital (JHACH)

    St. Petersburg, Florida, 33701, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • Orlando Health - Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • University of Florida - Shands Hospital

    Gainesville, Florida, 32608, United States

  • University of Texas at Houston - Children's Memorial Hermann Hospital

    Houston, Texas, 77030, United States

  • Wake Forest University - Brenner Children's Hospital

    Winston-Salem, North Carolina, 27157, United States

  • Washington University - St. Louis Children's Hospital (WUSTL)

    St Louis, Missouri, 63110, United States

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