Study Results
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Basic Information
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COMPLETED
NA
558 participants
INTERVENTIONAL
2010-07-31
2021-03-26
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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12 month surgery
Infants will receive primary surgery at age 12 months using Sommerlad technique
primary surgery for cleft palate
Surgery completed using the Sommerlad technique
6 month surgery
Infants will receive primary surgery at age 6 months using Sommerlad technique.
primary surgery for cleft palate
Surgery completed using the Sommerlad technique
Interventions
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primary surgery for cleft palate
Surgery completed using the Sommerlad technique
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
ALL
No
Sponsors
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University of Liverpool
OTHER
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
University of Copenhagen
OTHER
Göteborg University
OTHER
Kevin Munro
OTHER
Responsible Party
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Kevin Munro
Professor of Audiology
Principal Investigators
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Kevin J Munro
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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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
Malmo, , 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, , United Kingdom
Manchester University 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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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Sponsor Reference: 57201
Identifier Type: OTHER
Identifier Source: secondary_id
NIHR Portfolio Reference 30200
Identifier Type: OTHER
Identifier Source: secondary_id
09-017-E
Identifier Type: -
Identifier Source: org_study_id
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