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Completed

NCT Number: NCT00993551

Timing of Primary Surgery for Cleft Palate

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.

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Key information

Conditions

Cleft Palate Behavior Communication Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Speech Stomatognathic Diseases Stomatognathic System Abnormalities Verbal Behavior

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo, Bauru, Brazil

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

primary surgery for cleft palate

Procedure

Surgery completed using the Sommerlad technique

Primary outcomes

  1. Insufficient Velopharyngeal Function

    Time frame: 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 outcomes

  1. Velopharyngeal Composite Score Summary (VPC Sum)

    Time frame: 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.

  2. Insufficient Velopharyngeal Function

    Time frame: 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.

  3. Velopharyngeal Insufficiency Symptoms

    Time frame: 3 years of age

    The percentage of times that a target consonant uttered has a VPI symptom

  4. Canonical Babbling Present

    Time frame: 1 year of age

    Presence of canonical babbling of syllables

  5. Canonical Babbling Ratio

    Time frame: 1 year of age

    The proportion of times that a syllable produced is "canonical"

  6. Canonical Babbling Consonant Inventory

    Time frame: 1 year of age

    The number of unique consonants produced

  7. Articulation: Percent Consonant Correct (PCC)

    Time frame: 3 and 5 years of age

    The percentage of times that a target consonant is uttered correct

  8. Articulation: Percent Correct Placement (PCP)

    Time frame: 3 and 5 years of age

    Percentage of times that a target consonant has the correct place of articulation

  9. Articulation: Percent Correct Manner (PCM)

    Time frame: 3 and 5 years of age

    Percentage of times that a target consonant has the correct manner of articulation

  10. Articulation: Non-oral Consonant Errors

    Time frame: 3 and 5 years of age

    Percentage of times that a target consonant is realised as a non-oral error

  11. Articulation: Oral Consonant Errors

    Time frame: 3 and 5 years of age

    Percentage of times that a target consonant is realised as an oral error

  12. Postoperative/Long Term Complications: Dehiscence

    Time frame: 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.

  13. Postoperative/Long Term Complications: Infection

    Time frame: 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

  14. Postoperative/Long Term Complications: Evidence of Fistula

    Time frame: 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

  15. Hearing Level: Abnormal Transient Otoacoustic Emission (TEOAE)

    Time frame: 1 year of age

    A dichotomous outcome of whether the child has abnormal TEOAE, reported percentage of participants that were abnormal.

  16. Hearing Level: Abnormal Soundfield Audiometry

    Time frame: 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.

  17. Hearing Level: Abnormal Puretone Audiometry in at Least One Ear.

    Time frame: 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.

  18. Hearing Level: Abnormal Puretone Audiometry in Both Ears

    Time frame: 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.

  19. Hearing Level: Severity of Better Ear

    Time frame: 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

  20. Middle Ear Function: Flat Line Tympanogram in at Least One Ear

    Time frame: 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.

  21. Middle Ear Function: Flat Line Tympanogram in Both Ears

    Time frame: 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.

  22. Dentofacial Development: Soft Tissue ANB

    Time frame: 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

  23. Dentofacial Development: Maxillary Arch Constriction Score

    Time frame: 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.

  24. Growth: Nude Weight

    Time frame: 1 year of age

    Growth: Nude weight measured in kg

  25. Growth: Crown to Heel Length

    Time frame: 1 year of age

    Measured in centimetres and recorded to one decimal place.

  26. Growth: Occiptofrontal Circumference

    Time frame: 1 year of age

    Measured in centimetres and recorded to one decimal place.

Sponsors and collaborators

Lead sponsor

Kevin Munro

Other

Collaborators

  • Göteborg University
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of Copenhagen
  • University of Liverpool

Registry information

Acronym: TOPS

Important dates

Study start
2010
Primary completion
2020
Study completion
2021
First posted
Oct 12, 2009
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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