Timing of Primary Surgery for Cleft Palate (TOPS)
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ClinicalTrials.gov Identifier: NCT00993551 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 12, 2009
Last Update Posted
: November 20, 2017
|
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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 specified technique, at age 6 months, when compared to surgery using the same technique age 12 months, improves speech development. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes(age 5) and secondary outcomes.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cleft Palate | Procedure: primary surgery for cleft palate | Not Applicable |
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 (dental impressions and photographs)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 558 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Timing of Primary Surgery for Cleft Palate |
Study Start Date : | July 2010 |
Estimated Primary Completion Date : | August 2020 |
Estimated Study Completion Date : | September 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 12 month surgery
Infants will receive primary surgery at age 12 months using a standardized technique
|
Procedure: primary surgery for cleft palate
Surgery completed using the Sommerlad technique
|
Experimental: 6 month surgery
Infants will receive primary surgery at age 6 months using a standardized technique.
|
Procedure: primary surgery for cleft palate
Surgery completed using the Sommerlad technique
|
- The primary outcome measure for the TOPS trial is insufficient velopharyngeal function. [ Time Frame: 5 years ]Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6.
- Insufficient velopharyngeal function [ Time Frame: 3 years ]unit of measure to be confirmed. It will be measured by either "yes" or "no" or a 3 point scale; insufficient, marginal or sufficient
- Canonical babbling measured by canonical babbling present [ Time Frame: 12 months ]unit of measure: Yes or No c. Oral consonant errors
- Canonical babbling measured by canonical babbling ratio [ Time Frame: 12 months ]unit of measure: % of canonical babbling
- Canonical babbling measured by consonant inventory [ Time Frame: 12 months ]unit of measure: number of correct sounds produced
- Articulation [ Time Frame: 3 years ]unit of measure: % consonant correct (PCC)
- Articulation [ Time Frame: 3 years ]unit of measure: % correct placement (PCP)
- Articulation [ Time Frame: 3 years ]unit of measure: % correct manner (PCM)
- Articulation [ Time Frame: 3 years ]unit of measure: % of children with non-oral consonant errors
- Articulation [ Time Frame: 5 years ]unit of measure: % consonants correct (PCC)
- Articulation [ Time Frame: 5 years ]unit of measure: % of children with non-oral consonant errors
- Articulation [ Time Frame: 5 years ]unit of measure: % of children with oral consonant errors
- Postoperative/long term complications measured by dehiscence [ Time Frame: up to 48 hours post operation ]unit of measure: yes or no for dehiscence present
- Postoperative/long term complications measured by dehiscence [ Time Frame: up to 30 days post operation ]unit of measure: yes or no for dehiscence present
- Postoperative/long term complications measured by infection [ Time Frame: up to 48 hours post operation ]unit of measure: yes or no for infection present
- Postoperative/long term complications measured by infection [ Time Frame: up to 30 days post operation ]unit of measure: yes or no for infection present
- Postoperative/long term complications measured by evidence of fistula [ Time Frame: up to 30 days post operation ]unit of measure: yes or no for fistula present
- Postoperative/long term complications measured by evidence of fistula [ Time Frame: 3 years ]unit of measure: yes or no for fistula present
- Postoperative/long term complications measured by evidence of fistula [ Time Frame: 5 years ]unit of measure: yes or no for fistula present
- Hearing level [ Time Frame: 12 months ]unit of measure: yes or no by Abnormal Transient Otoacoustic Emission (TEOAE)
- Hearing level [ Time Frame: 12 months ]unit of measure: yes or no by Abnormal Soundfield audiometry
- Hearing level [ Time Frame: 3 years ]unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear
- Hearing level [ Time Frame: 3 years ]unit of measure: yes or no by Abnormal Puretone audiometry in both ears
- Hearing level [ Time Frame: 3 years ]unit of measure: Severity of better ear categorised as normal, mild, moderate or severe
- Hearing level [ Time Frame: 5 years ]unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear
- Hearing level [ Time Frame: 5 years ]unit of measure: yes or no by Abnormal Puretone audiometry in both ears
- Hearing level [ Time Frame: 5 years ]unit of measure: Severity of better ear categorised as normal, mild, moderate, severe or profound
- Middle ear function [ Time Frame: 12 months ]unit of measure: yes or no by flat line Tympanogram in at least one ear
- Middle ear function [ Time Frame: 3 years ]unit of measure: yes or no by flat line Tympanogram in at least one ear
- Middle ear function [ Time Frame: 5 years ]unit of measure: yes or no by flat line Tympanogram in at least one ear
- Middle ear function [ Time Frame: 12 months ]unit of measure: yes or no by flat line Tympanogram in both ears
- Middle ear function [ Time Frame: 3 years ]unit of measure: yes or no by flat line Tympanogram in both ears
- Middle ear function [ Time Frame: 5 years ]unit of measure: yes or no by flat line Tympanogram in both ears
- Dentofacial development [ Time Frame: 5 years ]unit of measure: Degrees (0-360) soft tissue ANB (the angle between soft tissue nasion, A point and B point on a profile photograph)
- Dentofacial development [ Time Frame: 5 years ]unit of measure: Maxillary arch constriction score using Modified Huddart/Bodenham 25 point scoring system (-22 to +2)
- Growth [ Time Frame: 12 months ]unit of measure: nude weight in grams (g)
- Growth [ Time Frame: 12 months ]unit of measure: crown to heel length measure in centimetres (cm)
- Growth [ Time Frame: 12 months ]unit of measure: occipitofrontal circumference in centimetres (cm)

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Ages Eligible for Study: | up to 6 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants with isolated cleft palate
- Medically fit for operation at 6 months
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993551
Brazil | |
University of Sao Paulo | |
Bauru, Brazil | |
Denmark | |
Copenhagen Cleft Palate Centre | |
Copenhagen, Denmark | |
Århus Speech and Hearing Institute | |
Århus, Denmark | |
Norway | |
Helse Bergen HF | |
Bergen, Norway | |
Oslo University Hospital | |
Oslo, Norway | |
Sweden | |
Göteborg University | |
Göteborg, Sweden | |
University of Linköping | |
Linköping, Sweden | |
Malmö University Hospital | |
Malmö, Sweden | |
Karolinska University Hospital | |
Stockholm, Sweden | |
Umeå University | |
Umeå, Sweden | |
Uppsala University | |
Uppsala, Sweden | |
United Kingdom | |
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, United Kingdom, L12 2AP | |
Central Manchester University Hospitals NHS Foundation Trust | |
Manchester, 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 |
Principal Investigator: | William C Shaw | University of Manchester |
Responsible Party: | William Shaw, Professor of Orthodontics Dentofacial Development, University of Manchester |
ClinicalTrials.gov Identifier: | NCT00993551 History of Changes |
Other Study ID Numbers: |
09-017-E 1U01DE018837-01A1 ( U.S. NIH Grant/Contract ) Sponsor Reference: 57201 ( Other Identifier: The University of Manchester (UK) ) NIHR Portfolio Reference 30200 ( Other Identifier: NIHR ) |
First Posted: | October 12, 2009 Key Record Dates |
Last Update Posted: | November 20, 2017 |
Last Verified: | November 2017 |
Keywords provided by William Shaw, University of Manchester:
cleft palate paediatric pediatric |
surgery speech velopharyngeal |
Additional relevant MeSH terms:
Cleft Palate Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases Maxillofacial Abnormalities Craniofacial Abnormalities |
Musculoskeletal Abnormalities Stomatognathic Diseases Mouth Abnormalities Mouth Diseases Stomatognathic System Abnormalities Congenital Abnormalities |