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Timing of cleft palate repair may shape a child's speech

NCT ID NCT00993551

Disease control Sponsor: Kevin Munro 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether repairing an isolated cleft palate at 6 months of age leads to better speech than waiting until 12 months. About 650 infants across the UK, Scandinavia, and Brazil will be randomly assigned to one of the two surgery times. Doctors will measure how well the palate closes during speech at age 5, using a standard score. The goal is to find the best age for surgery to help children speak clearly.

What this could mean

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

Active substance
Primary surgery for cleft palate using the Sommerlad technique
What this could lead to
If earlier surgery works better, it could set a new standard for when to repair cleft palates, improving speech and quality of life for infants.
What could go wrong
The trial is large but still one study. Results may not apply to all cleft types, and surgery at any age carries risks like bleeding or infection.

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

558 people

The number who actually took part.

Start date

Jul 2010

Finished

Mar 2021

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

Up to 6 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: * Infants with isolated cleft palate * Medically fit for operation at 6 months, corrected for gestational age * Written informed proxy consent * One parent/carer a native language speaker in the country of residence Exclusion Criteria: * Consent not obtained * b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay * Congenital sensorineural hearing loss or middle ear anomalies; * Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate; * Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988). * Where the language spoken at home is not the majority language in the country of residence.

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Conditions

The condition(s) this trial relates to.

cleft palate isolated cleft palate Speech

As listed by the trial registrant

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

Cleft palate

Contacts and locations

Locations

  • Abertawe Bro Morgannwg University Health Board

    Swansea, United Kingdom

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, L12 2AP, United Kingdom

  • Belfast Health and Social Care Trust

    Belfast, United Kingdom

  • Birmingham Children's NHS Foundation Trust

    Birmingham, United Kingdom

  • Copenhagen Cleft Palate Centre

    Copenhagen, Denmark

  • Edinburgh Hospital for Sick Children

    Edinburgh, United Kingdom

  • Göteborg University

    Gothenburg, Sweden

  • Helse Bergen HF

    Bergen, Norway

  • Karolinska University Hospital

    Stockholm, Sweden

  • Leeds University Hospitals NHS foundation Trust

    Leeds, United Kingdom

  • Malmö University Hospital

    Malmö, Sweden

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL, United Kingdom

  • NHS Greater Glasgow and Clyde

    Glasgow, United Kingdom

  • Newcastle University Hospitals NHs Foundation Trust

    Newcastle, United Kingdom

  • North Bristol NHS Foundation Trust

    Bristol, United Kingdom

  • Oslo University Hospital

    Oslo, Norway

  • Oxford University Hospitals NHS Trust

    Oxford, United Kingdom

  • Salisbury District Hospital

    Salisbury, United Kingdom

  • Umeå University

    Umeå, Sweden

  • University of Linköping

    Linköping, Sweden

  • University of Sao Paulo

    Bauru, Brazil

  • Uppsala University

    Uppsala, Sweden

  • Århus Speech and Hearing Institute

    Aarhus, Denmark

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