Cleft PalateTOPSNCT00993551
Timing of Primary Surgery for Cleft Palate
A study testing primary surgery for cleft palate in people with Cleft Palate, run by Kevin Munro at 23 sites in 5 countries.
Trial summary
This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cleft Palate
- What is being tested?
- primary surgery for cleft palate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Jul 2010to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United Kingdom12 sites
Belfast Health and Social Care Trust
Belfast
Birmingham Children's NHS Foundation Trust
Birmingham
North Bristol NHS Foundation Trust
Bristol
Edinburgh Hospital for Sick Children
Edinburgh
NHS Greater Glasgow and Clyde
Glasgow
Leeds University Hospitals NHS foundation Trust
Leeds
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Newcastle University Hospitals NHs Foundation Trust
Newcastle
Oxford University Hospitals NHS Trust
Oxford
Salisbury District Hospital
Salisbury
Abertawe Bro Morgannwg University Health Board
Swansea
Sweden6 sites
Göteborg University
Gothenburg
University of Linköping
Linköping
Malmö University Hospital
Malmö
Karolinska University Hospital
Stockholm
Umeå University
Umeå
Uppsala University
Uppsala
Denmark2 sites
Århus Speech and Hearing Institute
Aarhus
Copenhagen Cleft Palate Centre
Copenhagen
About this study
This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil.
650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either:
Read more
- Surgery at age 6 months, OR
- Surgery at age 12 months.
The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.
Read the detailed description
Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed:
Age 12 months
- Speech development (canonical babbling)
- Audiological assessments
- Growth
Age 3 years
- Speech development
- Audiological assessments
Age 5 Years
- Speech development
- Audiological assessments
- Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)
- Conditions
- Cleft Palate
- Being tested
- primary surgery for cleft palate
- Keywords
- cleft palate, paediatric, pediatric, surgery, speech, velopharyngeal
- Medical subject headings
- Cleft Palate, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary surgery for cleft palateProcedure or surgery
Surgery completed using the Sommerlad technique
| Study group | Role | What they receive |
|---|---|---|
| 12 month surgery | Experimental | Infants will receive primary surgery at age 12 months using Sommerlad technique Receives: Procedure: primary surgery for cleft palate |
| 6 month surgery | Experimental | Infants will receive primary surgery at age 6 months using Sommerlad technique. Receives: Procedure: primary surgery for cleft palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insufficient Velopharyngeal Function
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Scores ≥ 4 on this scale are considered insufficient (higher scores indicate a worse outcome). This outcome is measured as a dichotomous variable (insufficient or not insufficient) with a cut-off threshold of ≥ 4 to indicate insufficient. We report this as a percentage of participants that are assessed as having insufficient velopharyngeal function.
Measured: 5 years of age
Secondary outcomes (26)
Velopharyngeal Composite Score Summary (VPC Sum)
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms.
Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Higher scores indicate increased severity.
Measured: 5 years of age
Insufficient Velopharyngeal Function
Velopharyngeal function (VPC rate) measured on a 3 point scale; insufficient, marginal or sufficient. Scale is dichotomised into insufficient or marginal/sufficient (with lower score indicating insufficient). Reported as percentage of participants with insufficient function.
Measured: 3 & 5 years of age
Velopharyngeal Insufficiency Symptoms
The percentage of times that a target consonant uttered has a VPI symptom
Measured: 3 years of age
Canonical Babbling Present
Presence of canonical babbling of syllables
Measured: 1 year of age
Canonical Babbling Ratio
The proportion of times that a syllable produced is "canonical"
Measured: 1 year of age
Canonical Babbling Consonant Inventory
The number of unique consonants produced
Measured: 1 year of age
Articulation: Percent Consonant Correct (PCC)
The percentage of times that a target consonant is uttered correct
Measured: 3 and 5 years of age
Articulation: Percent Correct Placement (PCP)
Percentage of times that a target consonant has the correct place of articulation
Measured: 3 and 5 years of age
Articulation: Percent Correct Manner (PCM)
Percentage of times that a target consonant has the correct manner of articulation
Measured: 3 and 5 years of age
Articulation: Non-oral Consonant Errors
Percentage of times that a target consonant is realised as a non-oral error
Measured: 3 and 5 years of age
Articulation: Oral Consonant Errors
Percentage of times that a target consonant is realised as an oral error
Measured: 3 and 5 years of age
Postoperative/Long Term Complications: Dehiscence
Assessment for presence (indicated as yes on a dichotomized scale of yes/no) of postoperative/long term complication of dehiscence reported as percentage.
Measured: Up to 30 days postoperatively
Postoperative/Long Term Complications: Infection
A dichotomous outcome of whether the child has a postoperative infection (indicated as yes on a dichotomized scale of yes/no) reported as a percentage
Measured: Up to 30 days postoperatively
Postoperative/Long Term Complications: Evidence of Fistula
Measured by assessment for presence (yes on a dichotomised scale of yes/no) for evidence of fistula, reported as percentage
Measured: Up to 5 years of age
Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)
A dichotomous outcome of whether the child has abnormal TEOAE, reported percentage of participants that were abnormal.
Measured: 1 year of age
Hearing Level: Abnormal Soundfield Audiometry
A dichotomous outcome of whether the child has abnormal sound field audiometry. Abnormal sound field audiometry is indicated by a measurement of >30 dB HL for at least one of four frequencies tested: 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz. Reported as percentage of participants with abnormal outcome.
Measured: 1 year of age
Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.
A dichotomous outcome of whether the child has abnormal pure tone audiometry. If testing by pure tone audiometry is not possible, sound field audiometry can be used in its place. Abnormal audiometry in at least one ear is indicated by a measurement of >20 dB HL using the pure tone method, >25 dB HL for sound field, for at least one of four frequencies tested: 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz.Reported as percentage of participants with abnormal outcome.
Measured: 3 and 5 years of age
Hearing Level: Abnormal Puretone Audiometry in Both Ears
A dichotomous outcome defined in the same way as Abnormal Puretone Audiometry in at least one ear. For participants who have both ears tested and both tested ears indicate abnormal audiometry. Reported as percentage of participants with abnormal outcome.
Measured: 3 and 5 years of age
Hearing Level: Severity of Better Ear
Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound. Reported as percentage of participants with hearing outcome below normal
Measured: 3 and 5 years of age
Middle Ear Function: Flat Line Tympanogram in at Least One Ear
Middle ear function is assessed by presence of flat line Tympanogram in at least one ear. Reported as percentage of particpants with abnormal finding consistent with middle ear effusion.
Measured: 1, 3 and 5 years of age
Middle Ear Function: Flat Line Tympanogram in Both Ears
Middle ear function is assessed by presence of flat line Tympanogram in both ears. Reported as percentage of participants with abnormal outcome.
Measured: 1, 3 and 5 years of age
Dentofacial Development: Soft Tissue ANB
The angle between soft tissue nasion, A point, and B point on a profile photograph. The unit of measure is angular degrees
Measured: 5 years of age
Dentofacial Development: Maxillary Arch Constriction Score
Maxillary arch constriction score: a bounded continuous outcome, measured using the Huddart/Bodenham scoring system, on a maxilliary and mandibular arches impression. A score can range from -24 to 8. A positive score is good, with negative scores indicating maxillary constriction.
Measured: 5 years of age
Growth: Nude Weight
Growth: Nude weight measured in kg
Measured: 1 year of age
Growth: Crown to Heel Length
Measured in centimetres and recorded to one decimal place.
Measured: 1 year of age
Growth: Occiptofrontal Circumference
Measured in centimetres and recorded to one decimal place.
Measured: 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startJul 2010
- Primary completionAug 2020
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Munro
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, National Institute of Dental and Craniofacial Research (NIDCR), University of Copenhagen, Göteborg University
- Responsible party
- Sponsor-investigator, Kevin Munro, University of Manchester
- Investigators
- Kevin J Munro, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993551
- Sponsor's protocol ID
- 09-017-E
- Other IDs
- 1U01DE018837-01A1, Sponsor Reference: 57201, NIHR Portfolio Reference 30200
- Acronym
- TOPS
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2009
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data anonymised (participants and Speech and Language Therapists)
Publications
Conroy EJ, Blazeby JM, Burnside G, Cook JA, Gamble C. Investigating the presence of surgical learning in the Timing of Primary Surgery for cleft palate randomised trial. Clin Trials. 2025 Apr;22(2):200-208. doi: 10.1177/17407745241302488. Epub 2025 Jan 10.
PubMed 39791255Gamble C, Persson C, Willadsen E, Albery L, Soegaard Andersen H, Zattoni Antoneli M, Appelqvist M, Aukner R, Bodling P, Bowden M, Brunnegard K, Cairns G, Calladine S, Campbell L, Clayton-Smith J, Cooper R, Conroy E, El-Angbawi A, Kildegaard Emborg B, Enfalt Wikman J, Fitzpatrick B, Fukushiro AP, Guedes de Azevedo Bento Goncalves C, Havstam C, Hvistendahl AK, Jorgensen LD, Klinto K, Berntsen Kvinnsland M, Larham C, Lemvik J, Leturgie L, Liljerehn E, Lodge N, Lohmander A, McMahon S, Mehendale F, Miguel HC, Moe M, Nielsen JB, Nyberg J, Pedersen NH, Phippen G, Alvarez Piazentin-Penna SH, Patrick K, Pliskin L, Rigby L, Semb G, Southby L, Sporre M, Bjorkman Taleman AS, Tangstad J, Trindade IEK, Underwood I, van Eeden S, Westberg LR, Williamson PR, Paciello Yamashita R, Munro K, Walsh T, Shaw W; TOPS Study Group. Timing of Primary Surgery for Cleft Palate. N Engl J Med. 2023 Aug 31;389(9):795-807. doi: 10.1056/NEJMoa2215162.
PubMed 37646677Willadsen E, Cooper R, Conroy E, Gamble C, Albery L, Andersen H, Appelqvist M, Bodling P, Bowden M, Brunnegard K, Enfalt J, van Eeden S, Goncalves C, Fukushiro A, Jorgensen L, Lemvik J, Leturgie L, Liljerehn E, Lodge N, McMahon S, Miguel H, Patrick K, Phippen G, Piazentin-Penna S, Southby L, Taleman AS, Tangstad J, Yamashita R, Shaw W, Munro K, Walsh T, Persson C. Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clin Linguist Phon. 2023 Jan 2;37(1):77-98. doi: 10.1080/02699206.2021.2012259. Epub 2022 Jan 31.
PubMed 35100923Conroy EJ, Cooper R, Shaw W, Persson C, Willadsen E, Munro KJ, Williamson PR, Semb G, Walsh T, Gamble C; TOPS trial management group. A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan. Trials. 2021 Jan 4;22(1):5. doi: 10.1186/s13063-020-04886-y.
PubMed 33397459Shaw W, Semb G, Lohmander A, Persson C, Willadsen E, Clayton-Smith J, Trindade IK, Munro KJ, Gamble C, Harman N, Conroy EJ, Weichart D, Williamson P. Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age. BMJ Open. 2019 Jul 11;9(7):e029780. doi: 10.1136/bmjopen-2019-029780.
PubMed 31300507
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Primary Surgery for Cleft Palate
- ClinicalTrials.gov ID
- NCT00993551
- Acronym / sponsor ID
- TOPS / 09-017-E
- Conditions
- Cleft Palate
- Keywords
- cleft palate, paediatric, pediatric, surgery, speech, velopharyngeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Kevin MunroUniversity, hospital or other
- Collaborators
- University of Liverpool, National Institute of Dental and Craniofacial Research (NIDCR), University of Copenhagen, Göteborg University
- Study start
- Jul 2010
- Primary completion
- Aug 2020 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil.
650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either:
- Surgery at age 6 months, OR
- Surgery at age 12 months.
The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.
Detailed description
Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed:
Age 12 months
- Speech development (canonical babbling)
- Audiological assessments
- Growth
Age 3 years
- Speech development
- Audiological assessments
Age 5 Years
- Speech development
- Audiological assessments
- Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 month surgery | Experimental | Procedure: primary surgery for cleft palateInfants will receive primary surgery at age 12 months using Sommerlad technique |
| 6 month surgery | Experimental | Procedure: primary surgery for cleft palateInfants will receive primary surgery at age 6 months using Sommerlad technique. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary surgery for cleft palateSurgery completed using the Sommerlad technique | Procedure or surgery | 12 month surgery, 6 month surgery |
Primary outcome
Insufficient Velopharyngeal Function
Time frame: 5 years of age
Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Scores ≥ 4 on this scale are considered insufficient (higher scores indicate a worse outcome). This outcome is measured as a dichotomous variable (insufficient or not insufficient) with a cut-off threshold of ≥ 4 to indicate insufficient. We report this as a percentage of participants that are assessed as having insufficient velopharyngeal function.
26 secondary outcomes
Velopharyngeal Composite Score Summary (VPC Sum)
Time frame: 5 years of age
Insufficient Velopharyngeal Function
Time frame: 3 & 5 years of age
Velopharyngeal Insufficiency Symptoms
Time frame: 3 years of age
Canonical Babbling Present
Time frame: 1 year of age
Canonical Babbling Ratio
Time frame: 1 year of age
Canonical Babbling Consonant Inventory
Time frame: 1 year of age
Articulation: Percent Consonant Correct (PCC)
Time frame: 3 and 5 years of age
Articulation: Percent Correct Placement (PCP)
Time frame: 3 and 5 years of age
Articulation: Percent Correct Manner (PCM)
Time frame: 3 and 5 years of age
Articulation: Non-oral Consonant Errors
Time frame: 3 and 5 years of age
Articulation: Oral Consonant Errors
Time frame: 3 and 5 years of age
Postoperative/Long Term Complications: Dehiscence
Time frame: Up to 30 days postoperatively
Postoperative/Long Term Complications: Infection
Time frame: Up to 30 days postoperatively
Postoperative/Long Term Complications: Evidence of Fistula
Time frame: Up to 5 years of age
Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)
Time frame: 1 year of age
Hearing Level: Abnormal Soundfield Audiometry
Time frame: 1 year of age
Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.
Time frame: 3 and 5 years of age
Hearing Level: Abnormal Puretone Audiometry in Both Ears
Time frame: 3 and 5 years of age
Hearing Level: Severity of Better Ear
Time frame: 3 and 5 years of age
Middle Ear Function: Flat Line Tympanogram in at Least One Ear
Time frame: 1, 3 and 5 years of age
Middle Ear Function: Flat Line Tympanogram in Both Ears
Time frame: 1, 3 and 5 years of age
Dentofacial Development: Soft Tissue ANB
Time frame: 5 years of age
Dentofacial Development: Maxillary Arch Constriction Score
Time frame: 5 years of age
Growth: Nude Weight
Time frame: 1 year of age
Growth: Crown to Heel Length
Time frame: 1 year of age
Growth: Occiptofrontal Circumference
Time frame: 1 year of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39791255Conroy EJ, Blazeby JM, Burnside G, Cook JA, Gamble C. Investigating the presence of surgical learning in the Timing of Primary Surgery for cleft palate randomised trial. Clin Trials. 2025 Apr;22(2):200-208. doi: 10.1177/17407745241302488. Epub 2025 Jan 10.
- Derived from this study: PubMed 37646677Gamble C, Persson C, Willadsen E, Albery L, Soegaard Andersen H, Zattoni Antoneli M, Appelqvist M, Aukner R, Bodling P, Bowden M, Brunnegard K, Cairns G, Calladine S, Campbell L, Clayton-Smith J, Cooper R, Conroy E, El-Angbawi A, Kildegaard Emborg B, Enfalt Wikman J, Fitzpatrick B, Fukushiro AP, Guedes de Azevedo Bento Goncalves C, Havstam C, Hvistendahl AK, Jorgensen LD, Klinto K, Berntsen Kvinnsland M, Larham C, Lemvik J, Leturgie L, Liljerehn E, Lodge N, Lohmander A, McMahon S, Mehendale F, Miguel HC, Moe M, Nielsen JB, Nyberg J, Pedersen NH, Phippen G, Alvarez Piazentin-Penna SH, Patrick K, Pliskin L, Rigby L, Semb G, Southby L, Sporre M, Bjorkman Taleman AS, Tangstad J, Trindade IEK, Underwood I, van Eeden S, Westberg LR, Williamson PR, Paciello Yamashita R, Munro K, Walsh T, Shaw W; TOPS Study Group. Timing of Primary Surgery for Cleft Palate. N Engl J Med. 2023 Aug 31;389(9):795-807. doi: 10.1056/NEJMoa2215162.
- Derived from this study: PubMed 35100923Willadsen E, Cooper R, Conroy E, Gamble C, Albery L, Andersen H, Appelqvist M, Bodling P, Bowden M, Brunnegard K, Enfalt J, van Eeden S, Goncalves C, Fukushiro A, Jorgensen L, Lemvik J, Leturgie L, Liljerehn E, Lodge N, McMahon S, Miguel H, Patrick K, Phippen G, Piazentin-Penna S, Southby L, Taleman AS, Tangstad J, Yamashita R, Shaw W, Munro K, Walsh T, Persson C. Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clin Linguist Phon. 2023 Jan 2;37(1):77-98. doi: 10.1080/02699206.2021.2012259. Epub 2022 Jan 31.
- Derived from this study: PubMed 33397459Conroy EJ, Cooper R, Shaw W, Persson C, Willadsen E, Munro KJ, Williamson PR, Semb G, Walsh T, Gamble C; TOPS trial management group. A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan. Trials. 2021 Jan 4;22(1):5. doi: 10.1186/s13063-020-04886-y.
- Derived from this study: PubMed 31300507Shaw W, Semb G, Lohmander A, Persson C, Willadsen E, Clayton-Smith J, Trindade IK, Munro KJ, Gamble C, Harman N, Conroy EJ, Weichart D, Williamson P. Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age. BMJ Open. 2019 Jul 11;9(7):e029780. doi: 10.1136/bmjopen-2019-029780.
- Individual participant dataSharing planned: Yes. Data anonymised (participants and Speech and Language Therapists)
Related trials for Cleft Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Furlow With Buccinator and Fistula Formation
Cleft Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J Munro principal investigator
University of Manchester
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary surgery for cleft palate in people with Cleft Palate, run by Kevin Munro at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Sweden, Denmark, Norway, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insufficient Velopharyngeal Function (time frame: 5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993551, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.