Timing of Primary Surgery for Cleft Palate

Study Overview
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Brief Summary
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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 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
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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)

Official Title
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Timing of Primary Surgery for Cleft Palate

Conditions
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Cleft Palate

Intervention / Treatment
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* Procedure: primary surgery for cleft palate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 month surgery<br>Infants will receive primary surgery at age 12 months using Sommerlad technique | Procedure: primary surgery for cleft palate<br>* Surgery completed using the Sommerlad technique<br>|
| Experimental: 6 month surgery<br>Infants will receive primary surgery at age 6 months using Sommerlad technique. | Procedure: primary surgery for cleft palate<br>* Surgery completed using the Sommerlad technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure for the TOPS trial is insufficient velopharyngeal function. | Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate) | Velopharyngeal function measured by combination of VPC sum and VPC rate. VPC sum is measured as for primary outcome measure and VPC rate on a 3 point scale; insufficient, marginal or sufficient | 3 and 5 years | 
| Velopharyngeal function: Velopharyngeal insufficiency symptoms | It will be measured either by presence of resonance yes within normal limit or no if not within normal limit | 3 years | 
| Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio | Canonical babbling is measured by presence of vocalised syllables and percentage ( ratio) of children vocalising canonical or non canonical babbling of syllables | 12 months | 
| Canonical babbling; 3.Consonant inventory | Consonant inventory is measured by the number of correct sounds produced | 12 months | 
| Articulation: 1. Percent consonant correct (PCC) | Articulation is measured by the percentage of children vocalising the correct consonants | 3 and 5 years | 
| Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors | Articulation is measured by the percentage of children vocalising correct consonants ( oral and non-oral) in the correct placement and manner | 3 and 5 years | 
| Postoperative/long term complications | Complications are measured by assessment for presence (yes or no) of the following:1.Dehiscence 2.Infection 3.Evidence of fistula | 48 hours and 30 days postoperatively | 
| Postoperative/long term complications | measured by assessment for presence (yes or no) or evidence of fistula | at 3 and 5 year follow up | 
| Hearing: hearing level assessment | Assessment of hearing level by Tympanometry and abnormal transient otoacoustic emission (TEOAE) | 12 months | 
| Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears. | Hearing level is assessed by Puretone audiometry | 3 and 5 years | 
| Hearing level assessment | Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound. | 3 and 5 years | 
| Middle ear function | Middle ear function is assessed by presence of flat line Tympanogram in at least one ear and or both ears | 12 months, 3 and 5 years | 
| Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion, | Soft tissue development is measured by measuring the angle between two points (SSs-ns-sms) on a profile photograph. The unit of measure is angular degrees | 5 years | 
| Dentofacial development; Maxillary arch constriction score | This outcome is assesed using modified Huddart/Bodenham scoring system which is a range from -24 to +8 | 5 years | 
| Growth assessment for nude weight | Growth is measured in Kg body weight in nude | 12 months | 
| Growth Assessment for crown to heel length and occipitofrontal circumference | Assessment for crown to heel length and Occipitofrontal circumference are in centimetres. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft palate, paediatric, pediatric, surgery, speech, velopharyngeal