Timing of Primary Surgery for Cleft Palate (TOPS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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 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

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 (dental impressions and photographs)

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. Canonical babbling measured by canonical babbling present [ Time Frame: 12 months ]
   unit of measure: Yes or No c. Oral consonant errors
3. Canonical babbling measured by canonical babbling ratio [ Time Frame: 12 months ]
   unit of measure: % of canonical babbling
4. Canonical babbling measured by consonant inventory [ Time Frame: 12 months ]
   unit of measure: number of correct sounds produced
5. Articulation [ Time Frame: 3 years ]
   unit of measure: % consonant correct (PCC)
6. Articulation [ Time Frame: 3 years ]
   unit of measure: % correct placement (PCP)
7. Articulation [ Time Frame: 3 years ]
   unit of measure: % correct manner (PCM)
8. Articulation [ Time Frame: 3 years ]
   unit of measure: % of children with non-oral consonant errors
9. Articulation [ Time Frame: 5 years ]
   unit of measure: % consonants correct (PCC)
10. Articulation [ Time Frame: 5 years ]
    unit of measure: % of children with non-oral consonant errors
11. Articulation [ Time Frame: 5 years ]
    unit of measure: % of children with oral consonant errors
12. Postoperative/long term complications measured by dehiscence [ Time Frame: up to 48 hours post operation ]
    unit of measure: yes or no for dehiscence present
13. Postoperative/long term complications measured by dehiscence [ Time Frame: up to 30 days post operation ]
    unit of measure: yes or no for dehiscence present
14. Postoperative/long term complications measured by infection [ Time Frame: up to 48 hours post operation ]
    unit of measure: yes or no for infection present
15. Postoperative/long term complications measured by infection [ Time Frame: up to 30 days post operation ]
    unit of measure: yes or no for infection present
16. 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
17. Postoperative/long term complications measured by evidence of fistula [ Time Frame: 3 years ]
    unit of measure: yes or no for fistula present
18. Postoperative/long term complications measured by evidence of fistula [ Time Frame: 5 years ]
    unit of measure: yes or no for fistula present
19. Hearing level [ Time Frame: 12 months ]
    unit of measure: yes or no by Abnormal Transient Otoacoustic Emission (TEOAE)
20. Hearing level [ Time Frame: 12 months ]
    unit of measure: yes or no by Abnormal Soundfield audiometry
21. Hearing level [ Time Frame: 3 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear
22. Hearing level [ Time Frame: 3 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in both ears
23. Hearing level [ Time Frame: 3 years ]
    unit of measure: Severity of better ear categorised as normal, mild, moderate or severe
24. Hearing level [ Time Frame: 5 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear
25. Hearing level [ Time Frame: 5 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in both ears
26. Hearing level [ Time Frame: 5 years ]
    unit of measure: Severity of better ear categorised as normal, mild, moderate, severe or profound
27. Middle ear function [ Time Frame: 12 months ]
    unit of measure: yes or no by flat line Tympanogram in at least one ear
28. Middle ear function [ Time Frame: 3 years ]
    unit of measure: yes or no by flat line Tympanogram in at least one ear
29. Middle ear function [ Time Frame: 5 years ]
    unit of measure: yes or no by flat line Tympanogram in at least one ear
30. Middle ear function [ Time Frame: 12 months ]
    unit of measure: yes or no by flat line Tympanogram in both ears
31. Middle ear function [ Time Frame: 3 years ]
    unit of measure: yes or no by flat line Tympanogram in both ears
32. Middle ear function [ Time Frame: 5 years ]
    unit of measure: yes or no by flat line Tympanogram in both ears
33. 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)
34. Dentofacial development [ Time Frame: 5 years ]
    unit of measure: Maxillary arch constriction score using Modified Huddart/Bodenham 25 point scoring system (-22 to +2)
35. Growth [ Time Frame: 12 months ]
    unit of measure: nude weight in grams (g)
36. Growth [ Time Frame: 12 months ]
    unit of measure: crown to heel length measure in centimetres (cm)
37. Growth [ Time Frame: 12 months ]
    unit of measure: occipitofrontal circumference in centimetres (cm)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 6 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

William Shaw

University of Liverpool

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:	William C Shaw	University of Manchester

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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