Cleft Palate
Conditions
Keywords
cleft palate, paediatric, pediatric, surgery, speech, velopharyngeal
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)
Interventions
PROCEDUREprimary surgery for cleft palate
Surgery completed using the Sommerlad technique
Sponsors
Kevin Munro
University of Liverpool
National Institute of Dental and Craniofacial Research (NIDCR)
University of Copenhagen
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insufficient Velopharyngeal Function | 5 years of age | Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Scores ≥ 4 on this scale are considered insufficient (higher scores indicate a worse outcome). This outcome is measured as a dichotomous variable (insufficient or not insufficient) with a cut-off threshold of ≥ 4 to indicate insufficient. We report this as a percentage of participants that are assessed as having insufficient velopharyngeal function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative/Long Term Complications: Infection | Up to 30 days postoperatively | A dichotomous outcome of whether the child has a postoperative infection (indicated as yes on a dichotomized scale of yes/no) reported as a percentage |
| Postoperative/Long Term Complications: Evidence of Fistula | Up to 5 years of age | Measured by assessment for presence (yes on a dichotomised scale of yes/no) for evidence of fistula, reported as percentage |
| Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE) | 1 year of age | A dichotomous outcome of whether the child has abnormal TEOAE, reported percentage of participants that were abnormal. |
| Hearing Level: Abnormal Soundfield Audiometry | 1 year of age | A dichotomous outcome of whether the child has abnormal sound field audiometry. Abnormal sound field audiometry is indicated by a measurement of \>30 dB HL for at least one of four frequencies tested: 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz. Reported as percentage of participants with abnormal outcome. |
| Hearing Level: Abnormal Puretone Audiometry in at Least One Ear. | 3 and 5 years of age | A dichotomous outcome of whether the child has abnormal pure tone audiometry. If testing by pure tone audiometry is not possible, sound field audiometry can be used in its place. Abnormal audiometry in at least one ear is indicated by a measurement of \>20 dB HL using the pure tone method, \>25 dB HL for sound field, for at least one of four frequencies tested: 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz.Reported as percentage of participants with abnormal outcome. |
| Hearing Level: Abnormal Puretone Audiometry in Both Ears | 3 and 5 years of age | A dichotomous outcome defined in the same way as Abnormal Puretone Audiometry in at least one ear. For participants who have both ears tested and both tested ears indicate abnormal audiometry. Reported as percentage of participants with abnormal outcome. |
| Hearing Level: Severity of Better Ear | 3 and 5 years of age | Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound. Reported as percentage of participants with hearing outcome below normal |
| Middle Ear Function: Flat Line Tympanogram in at Least One Ear | 1, 3 and 5 years of age | Middle ear function is assessed by presence of flat line Tympanogram in at least one ear. Reported as percentage of particpants with abnormal finding consistent with middle ear effusion. |
| Middle Ear Function: Flat Line Tympanogram in Both Ears | 1, 3 and 5 years of age | Middle ear function is assessed by presence of flat line Tympanogram in both ears. Reported as percentage of participants with abnormal outcome. |
| Dentofacial Development: Soft Tissue ANB | 5 years of age | The angle between soft tissue nasion, A point, and B point on a profile photograph. The unit of measure is angular degrees |
| Dentofacial Development: Maxillary Arch Constriction Score | 5 years of age | Maxillary arch constriction score: a bounded continuous outcome, measured using the Huddart/Bodenham scoring system, on a maxilliary and mandibular arches impression. A score can range from -24 to 8. A positive score is good, with negative scores indicating maxillary constriction. |
| Growth: Nude Weight | 1 year of age | Growth: Nude weight measured in kg |
| Growth: Crown to Heel Length | 1 year of age | Measured in centimetres and recorded to one decimal place. |
| Growth: Occiptofrontal Circumference | 1 year of age | Measured in centimetres and recorded to one decimal place. |
| Articulation: Percent Correct Placement (PCP) | 3 and 5 years of age | Percentage of times that a target consonant has the correct place of articulation |
| Articulation: Percent Correct Manner (PCM) | 3 and 5 years of age | Percentage of times that a target consonant has the correct manner of articulation |
| Articulation: Non-oral Consonant Errors | 3 and 5 years of age | Percentage of times that a target consonant is realised as a non-oral error |
| Articulation: Oral Consonant Errors | 3 and 5 years of age | Percentage of times that a target consonant is realised as an oral error |
| Articulation: Percent Consonant Correct (PCC) | 3 and 5 years of age | The percentage of times that a target consonant is uttered correct |
| Velopharyngeal Composite Score Summary (VPC Sum) | 5 years of age | Measured by the Velopharyngeal Composite Score (VPC sum), which is a sum of scores, based on three components: hypernasality, non-oral errors, and VPI symptoms. Each component is scored between 0 and 2. The sum of the three scores gives the VPC sum (0-6). Higher scores indicate increased severity. |
| Insufficient Velopharyngeal Function | 3 & 5 years of age | Velopharyngeal function (VPC rate) measured on a 3 point scale; insufficient, marginal or sufficient. Scale is dichotomised into insufficient or marginal/sufficient (with lower score indicating insufficient). Reported as percentage of participants with insufficient function. |
| Velopharyngeal Insufficiency Symptoms | 3 years of age | The percentage of times that a target consonant uttered has a VPI symptom |
| Canonical Babbling Present | 1 year of age | Presence of canonical babbling of syllables |
| Canonical Babbling Ratio | 1 year of age | The proportion of times that a syllable produced is "canonical" |
| Postoperative/Long Term Complications: Dehiscence | Up to 30 days postoperatively | Assessment for presence (indicated as yes on a dichotomized scale of yes/no) of postoperative/long term complication of dehiscence reported as percentage. |
| Canonical Babbling Consonant Inventory | 1 year of age | The number of unique consonants produced |
Countries
Brazil, Denmark, Norway, Sweden, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORKevin J Munro
University of Manchester
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized below 6 months at randomisation | 273 Participants |
| Race/Ethnicity, Customized Race Asian | 11 Participants |
| Race/Ethnicity, Customized Race Black | 10 Participants |
| Race/Ethnicity, Customized Race Chinese | 0 Participants |
| Race/Ethnicity, Customized Race Mixed | 29 Participants |
| Race/Ethnicity, Customized Race Not stated | 4 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 494 Participants |
| Region of Enrollment Brazil | 165 participants |
| Region of Enrollment Denmark | 45 participants |
| Region of Enrollment Norway | 49 participants |
| Region of Enrollment Sweden | 69 participants |
| Region of Enrollment United Kingdom | 124 participants |
| Sex: Female, Male Female | 327 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 259 | 0 / 262 |
| other Total, other adverse events | 0 / 259 | 0 / 262 |
| serious Total, serious adverse events | 3 / 259 | 1 / 262 |
Outcome results
None listed