CompletedNCT00993551TOPSUpdated Sep 2, 2026Results posted

Timing of Primary Surgery for Cleft Palate

An interventional study of primary surgery for cleft palate in Cleft Palate, sponsored by Kevin Munro. Completed at 23 sites in 5 countries. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Kevin Munro · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 558
Allocation: Randomized
Ages: Up to 6 Months
Sex: All

Study 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 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.

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 studied

Cleft Palate

Browse trials for

Keywords

cleft palate
paediatric
pediatric
surgery
speech
velopharyngeal

In context

Cleft Palate

123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.

This study's enrollment of 558 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.

Browse Cleft Palate studies →

Lead sponsor

This is the only study on the registry with Kevin Munro as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 6 Months
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 558 participants (actual)

Study arms

Experimental
12 month surgery
Infants will receive primary surgery at age 12 months using Sommerlad technique
Procedure: primary surgery for cleft palate
Experimental
6 month surgery
Infants will receive primary surgery at age 6 months using Sommerlad technique.
Procedure: primary surgery for cleft palate

Interventions

Procedureprimary surgery for cleft palate
Surgery completed using the Sommerlad technique

What researchers measure

Primary outcomes

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.
Time frame: 5 years of age

Secondary outcomes

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.
Time frame: 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.
Time frame: 3 & 5 years of age
Velopharyngeal Insufficiency Symptoms
The percentage of times that a target consonant uttered has a VPI symptom
Time frame: 3 years of age
Canonical Babbling Present
Presence of canonical babbling of syllables
Time frame: 1 year of age
Canonical Babbling Ratio
The proportion of times that a syllable produced is "canonical"
Time frame: 1 year of age
Canonical Babbling Consonant Inventory
The number of unique consonants produced
Time frame: 1 year of age
Articulation: Percent Consonant Correct (PCC)
The percentage of times that a target consonant is uttered correct
Time frame: 3 and 5 years of age
Articulation: Percent Correct Placement (PCP)
Percentage of times that a target consonant has the correct place of articulation
Time frame: 3 and 5 years of age
Articulation: Percent Correct Manner (PCM)
Percentage of times that a target consonant has the correct manner of articulation
Time frame: 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
Time frame: 3 and 5 years of age
Articulation: Oral Consonant Errors
Percentage of times that a target consonant is realised as an oral error
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 5 years of age
Growth: Nude Weight
Growth: Nude weight measured in kg
Time frame: 1 year of age
Growth: Crown to Heel Length
Measured in centimetres and recorded to one decimal place.
Time frame: 1 year of age
Growth: Occiptofrontal Circumference
Measured in centimetres and recorded to one decimal place.
Time frame: 1 year of age

Results

Posted Sep 2, 2026

Participant flow

Participant flow — Overall Study
Milestone	6 Month Surgery	12 Month Surgery
Started	281	277
Completed	235	226
Not completed	46	51
Withdrew: Withdrawal by subject	19	21
Withdrew: No appointment due to covid	7	8
Withdrew: Recording not received	11	17
Withdrew: Recording od insufficient quality	7	1
Withdrew: No consent to use collected data	2	4

Outcome measures

PrimaryInsufficient 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.

Time frame:: 5 years of age
Reported as:: Count of participants · Participants

Insufficient Velopharyngeal Function
Participants	6 Month Surgery	12 Month Surgery
Insufficient Velopharyngeal Function	21	34

Statistical analysis

6 Month Surgery vs 12 Month Surgery · Chi-squared · p = 0.043 (5% level of statistical significance) · Risk ratio (rr): 0.59 · 95% CI 0.36 to 0.99surgery at 6 months compared to surgery at 12 months

SecondaryVelopharyngeal Composite Score Summary (VPC Sum)

Time frame:: 5 years of age
Reported as:: Mean · score on a scale

Velopharyngeal Composite Score Summary (VPC Sum)
score on a scale	6 Month Surgery	12 Month Surgery
Velopharyngeal Composite Score Summary (VPC Sum)	0.93 ± 1.47	1.17 ± 1.69

Statistical analysis

6 Month Surgery vs 12 Month Surgery · Mean difference (final values): -0.24 · 95% CI -0.53 to -0.05

SecondaryInsufficient 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.

Time frame:: 3 & 5 years of age
Reported as:: Count of participants · Participants

Insufficient Velopharyngeal Function
Participants	6 Month Surgery	12 Month Surgery
Outcome at 3 yrs	25	19
Outcome at 5yrs	21	20

SecondaryVelopharyngeal Insufficiency Symptoms

The percentage of times that a target consonant uttered has a VPI symptom

Time frame:: 3 years of age
Reported as:: Median · Percentage

Velopharyngeal Insufficiency Symptoms
Percentage	6 Month Surgery	12 Month Surgery
Velopharyngeal Insufficiency Symptoms	3.33 (0.0 to 12.5)	3.33 (0.0 to 13.3)

SecondaryCanonical Babbling Present

Presence of canonical babbling of syllables

Time frame:: 1 year of age
Reported as:: Count of participants · Participants

Canonical Babbling Present
Participants	6 Month Surgery	12 Month Surgery
Canonical Babbling Present	204	154

SecondaryCanonical Babbling Ratio

The proportion of times that a syllable produced is "canonical"

Time frame:: 1 year of age
Reported as:: Mean · Proportion of canonical syllables

Canonical Babbling Ratio
Proportion of canonical syllables	6 Month Surgery	12 Month Surgery
Canonical Babbling Ratio	0.41 ± 0.22	0.28 ± 0.21

SecondaryCanonical Babbling Consonant Inventory

The number of unique consonants produced

Time frame:: 1 year of age
Reported as:: Mean · number of unique consonants produced

Canonical Babbling Consonant Inventory
number of unique consonants produced	6 Month Surgery	12 Month Surgery
Canonical Babbling Consonant Inventory	4.54 ± 2.34	2.91 ± 1.68

SecondaryArticulation: Percent Consonant Correct (PCC)

The percentage of times that a target consonant is uttered correct

Time frame:: 3 and 5 years of age
Reported as:: Median · Percentage of target consonants correct

Articulation: Percent Consonant Correct (PCC)
Percentage of target consonants correct	6 Month Surgery	12 Month Surgery
3 years of age	73.7 (53.6 to 88.5)	70 (55.0 to 86.7)
5 years of age	88.9 (77.8 to 97.2)	88.9 (77.8 to 94.4)

SecondaryArticulation: Percent Correct Placement (PCP)

Percentage of times that a target consonant has the correct place of articulation

Time frame:: 3 and 5 years of age
Reported as:: Median · % of consonants correct placement

Articulation: Percent Correct Placement (PCP)
% of consonants correct placement	6 Month Surgery	12 Month Surgery
3 years	82.45 (64.0 to 92.3)	80.0 (63.3 to 90.0)
5 years	94.4 (83.3 to 97.2)	91.7 (83.3 to 97.2)

SecondaryArticulation: Percent Correct Manner (PCM)

Percentage of times that a target consonant has the correct manner of articulation

Time frame:: 3 and 5 years of age
Reported as:: Median · percentage of consonants correct

Articulation: Percent Correct Manner (PCM)
percentage of consonants correct	6 Month Surgery	12 Month Surgery
3 years	93.3 (80.8 to 100.0)	93.3 (80.0 to 96.7)
5 years	97.2 (94.4 to 100)	97.2 (94.4 to 100)

SecondaryArticulation: Non-oral Consonant Errors

Percentage of times that a target consonant is realised as a non-oral error

Time frame:: 3 and 5 years of age
Reported as:: Median · percentage of non oral errors

Articulation: Non-oral Consonant Errors
percentage of non oral errors	6 Month Surgery	12 Month Surgery
3 years	0.0 (0.0 to 6.7)	0.0 (0.0 to 5.3)
5 years	0 (0 to 0)	0 (0 to 0)

SecondaryArticulation: Oral Consonant Errors

Percentage of times that a target consonant is realised as an oral error

Time frame:: 3 and 5 years of age
Reported as:: Median · % of oral errors

Articulation: Oral Consonant Errors
% of oral errors	6 Month Surgery	12 Month Surgery
3 years	0.0 (0.0 to 3.5)	0.0 (0.0 to 3.6)
5 years	0 (0 to 0)	0 (0 to 2.8)

SecondaryPostoperative/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.

Time frame:: Up to 30 days postoperatively
Reported as:: Count of participants · Participants

Postoperative/Long Term Complications: Dehiscence
Participants	6 Month Surgery	12 Month Surgery
Postoperative/Long Term Complications: Dehiscence	24	23

SecondaryPostoperative/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

Time frame:: Up to 30 days postoperatively
Reported as:: Count of participants · Participants

Postoperative/Long Term Complications: Infection
Participants	6 Month Surgery	12 Month Surgery
Postoperative/Long Term Complications: Infection	12	13

SecondaryPostoperative/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

Time frame:: Up to 5 years of age
Reported as:: Count of participants · Participants

Postoperative/Long Term Complications: Evidence of Fistula
Participants	6 Month Surgery	12 Month Surgery
Postoperative/Long Term Complications: Evidence of Fistula	40	33

SecondaryHearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)

A dichotomous outcome of whether the child has abnormal TEOAE, reported percentage of participants that were abnormal.

Time frame:: 1 year of age
Reported as:: Count of participants · Participants

Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)
Participants	6 Month Surgery	12 Month Surgery
Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)	20	50

SecondaryHearing 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.

Time frame:: 1 year of age
Reported as:: Count of participants · Participants

Hearing Level: Abnormal Soundfield Audiometry
Participants	6 Month Surgery	12 Month Surgery
Hearing Level: Abnormal Soundfield Audiometry	51	87

SecondaryHearing 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.

Time frame:: 3 and 5 years of age
Reported as:: Count of participants · Participants

Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.
Participants	6 Month Surgery	12 Month Surgery
3 years	94	101
5 years	78	70

SecondaryHearing 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.

Time frame:: 3 and 5 years of age
Reported as:: Count of participants · Participants

Hearing Level: Abnormal Puretone Audiometry in Both Ears
Participants	6 Month Surgery	12 Month Surgery
3 years	30	32
5 years	46	31

SecondaryHearing 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

Time frame:: 3 and 5 years of age
Reported as:: Count of participants · Participants

Hearing Level: Severity of Better Ear
Participants	6 Month Surgery	12 Month Surgery
3 years	67	72
5 years	36	21

SecondaryMiddle 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.

Time frame:: 1, 3 and 5 years of age
Reported as:: Count of participants · Participants

Middle Ear Function: Flat Line Tympanogram in at Least One Ear
Participants	6 Month Surgery	12 Month Surgery
1 year	122	177
3 years	109	95
5 years	82	72

SecondaryMiddle 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.

Time frame:: 1, 3 and 5 years of age
Reported as:: Count of participants · Participants

Middle Ear Function: Flat Line Tympanogram in Both Ears
Participants	6 Month Surgery	12 Month Surgery
1 year	96	158
3 years	80	61
5 years	41	39

SecondaryDentofacial 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

Time frame:: 5 years of age
Reported as:: Mean · Units in degrees

Dentofacial Development: Soft Tissue ANB
Units in degrees	6 Month Surgery	12 Month Surgery
Dentofacial Development: Soft Tissue ANB	8.6 ± 2.6	8.6 ± 2.4

SecondaryDentofacial 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.

Time frame:: 5 years of age
Reported as:: Mean · score on a scale

Dentofacial Development: Maxillary Arch Constriction Score
score on a scale	6 Month Surgery	12 Month Surgery
Dentofacial Development: Maxillary Arch Constriction Score	-2.6 ± 4.0	-1.6 ± 3.7

SecondaryGrowth: Nude Weight

Growth: Nude weight measured in kg

Time frame:: 1 year of age
Reported as:: Mean · kg

Growth: Nude Weight
kg	6 Month Surgery	12 Month Surgery
Growth: Nude Weight	9.5 ± 1.15	9.5 ± 1.1

SecondaryGrowth: Crown to Heel Length

Measured in centimetres and recorded to one decimal place.

Time frame:: 1 year of age
Reported as:: Mean · cm

Growth: Crown to Heel Length
cm	6 Month Surgery	12 Month Surgery
Growth: Crown to Heel Length	75.1 ± 3.6	75.1 ± 3.1

SecondaryGrowth: Occiptofrontal Circumference

Measured in centimetres and recorded to one decimal place.

Time frame:: 1 year of age
Reported as:: Mean · cm

Growth: Occiptofrontal Circumference
cm	6 Month Surgery	12 Month Surgery
Growth: Occiptofrontal Circumference	46.4 ± 1.8	46.3 ± 1.7

Adverse events

Collected over 48 hours and 30 days postoperatively, 3 and 5 years of age. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
6 Month Surgery	0/259 (0%)	3/259 (1.2%)	0/259 (0%)
12 Month Surgery	0/262 (0%)	1/262 (0.4%)	0/262 (0%)

Most frequent serious events

Most frequent serious events
Event	6 Month Surgery	12 Month Surgery
Poor feedingGeneral disorders	1/259	0/262
Upper airway obstructive featuresRespiratory, thoracic and mediastinal disorders	1/259	0/262
Upper airway infectionRespiratory, thoracic and mediastinal disorders	1/259	0/262
anaphylactic shockGeneral disorders	0/259	1/262

Baseline characteristics

In the 6 month surgery trial arm, two participants consented and subsequently withdrew consent for data to be used, reducing the number in this trial arm from 281 to 279; In the 12 month surgery trial arm, four participants consented and subsequently withdrew consent for data to be used, reducing the number in this trial arm from 277 to 273.

Age, Customized
Age, Customized(Participants)	6 Month Surgery	12 Month Surgery	Total
below 6 months at randomisation	279	273	552

Sex: Female, Male
Sex: Female, Male(Participants)	6 Month Surgery	12 Month Surgery	Total
Female	165	162	327
Male	114	111	225

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	6 Month Surgery	12 Month Surgery	Total
Race — Asian	4	7	11
Race — Black	2	8	10
Race — Chinese	0	0	0
Race — Mixed	13	16	29
Race — White	256	238	494
Race — Other	3	1	4
Race — Not stated	1	3	4

Region of Enrollment
Region of Enrollment(participants)	6 Month Surgery	12 Month Surgery	Total
Sweden	33	36	69
Norway	25	24	49
Brazil	83	82	165
Denmark	23	22	45
United Kingdom	117	124	241

Study locations

23 sites

University of Sao Paulo
Bauru, Brazil
Århus Speech and Hearing Institute
Aarhus, Denmark
Copenhagen Cleft Palate Centre
Copenhagen, Denmark
Helse Bergen HF
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Göteborg University
Gothenburg, Sweden
University of Linköping
Linköping, Sweden
Malmö University Hospital
Malmö, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umeå University
Umeå, Sweden
Uppsala University
Uppsala, Sweden
Belfast Health and Social Care Trust
Belfast, United Kingdom
Birmingham Children's NHS Foundation Trust
Birmingham, United Kingdom
North Bristol NHS Foundation Trust
Bristol, United Kingdom
Edinburgh Hospital for Sick Children
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds University Hospitals NHS foundation Trust
Leeds, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Newcastle University Hospitals NHs Foundation Trust
Newcastle, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Abertawe Bro Morgannwg University Health Board
Swansea, United Kingdom

References and documents

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 39791255 ↗
Gamble 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 37646677 ↗
Willadsen 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 35100923 ↗
Conroy 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 33397459 ↗
Shaw 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 documents

Study protocol ↗ · Mar 31, 2020
Statistical analysis plan ↗ · Mar 12, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Data anonymised (participants and Speech and Language Therapists)

Supporting information: Study protocol, Statistical analysis plan

Time frame: Immediately and up to 5 years after publication of the main paper

Access criteria: Researchers who provide a methodologically sound proposal and ethical approval as appropriate

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2010, a primary completion of Aug 2020 and a completion of Mar 2021. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2026, 6 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 9, 2009
First posted: Oct 12, 2009
Start: Jul 2010
Primary completionActual: Aug 2020
CompletionActual: Mar 26, 2021
Results first posted: Sep 2, 2026
Last update: Sep 2, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00993551
Lead sponsor: Kevin Munro
Collaborators: University of Liverpool, National Institute of Dental and Craniofacial Research (NIDCR), University of Copenhagen, Göteborg University
Responsible party: Kevin Munro (Professor of Audiology, University of Manchester) — Sponsor-investigator
First posted: Oct 12, 2009
Start date: Jul 2010
Primary completion: Aug 2020
Completion: Mar 26, 2021
Results posted: Sep 2, 2026
Last update: Sep 2, 2026

Study contacts

Kevin J Munro

principal investigator · University of Manchester

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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