Clinical trial NCT00993551: Timing of Primary Surgery for Cleft Palate
Official title: Timing of Primary Surgery for Cleft Palate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Keywords: cleft palate
paediatric
pediatric
surgery
speech
velopharyngeal
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: University of Copenhagen
name: Göteborg University
First posted: 2009-10-12
Enrollment: 558
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.
timeFrame: 5 years
Secondary outcomes:
measure: Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)
timeFrame: 3 and 5 years
measure: Velopharyngeal function: Velopharyngeal insufficiency symptoms
timeFrame: 3 years
measure: Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio
timeFrame: 12 months
measure: Canonical babbling; 3.Consonant inventory
timeFrame: 12 months
measure: Articulation: 1. Percent consonant correct (PCC)
timeFrame: 3 and 5 years
measure: Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors
timeFrame: 3 and 5 years
measure: Postoperative/long term complications
timeFrame: 48 hours and 30 days postoperatively
measure: Postoperative/long term complications
timeFrame: at 3 and 5 year follow up
measure: Hearing: hearing level assessment
timeFrame: 12 months
measure: Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.
timeFrame: 3 and 5 years
measure: Hearing level assessment
timeFrame: 3 and 5 years
measure: Middle ear function
timeFrame: 12 months, 3 and 5 years
measure: Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,
timeFrame: 5 years
measure: Dentofacial development; Maxillary arch constriction score
timeFrame: 5 years
measure: Growth assessment for nude weight
timeFrame: 12 months
measure: Growth Assessment for crown to heel length and occipitofrontal circumference
timeFrame: 12 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: University of Sao Paulo
city: Copenhagen
country: Denmark
facility: Copenhagen Cleft Palate Centre
city: Århus
country: Denmark
facility: Århus Speech and Hearing Institute
city: Bergen
country: Norway
facility: Helse Bergen HF
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Göteborg
country: Sweden
facility: Göteborg University
city: Linköping
country: Sweden
facility: University of Linköping
city: Malmö
country: Sweden
facility: Malmö University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Umeå University
city: Uppsala
country: Sweden
facility: Uppsala University
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Children's NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Edinburgh Hospital for Sick Children
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Leeds
country: United Kingdom
facility: Leeds University Hospitals NHS foundation Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Newcastle University Hospitals NHs Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University Health Board
Study officials:
affiliation: University of Manchester
name: Kevin J Munro
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.