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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

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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. The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.

    Time frame: 5 years

    Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6.

Secondary outcomes

  1. Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)

    Time frame: 3 and 5 years

    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

  2. Velopharyngeal function: Velopharyngeal insufficiency symptoms

    Time frame: 3 years

    It will be measured either by presence of resonance "yes" within normal limit or "no" if not within normal limit

  3. Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio

    Time frame: 12 months

    Canonical babbling is measured by presence of vocalised syllables and percentage ( ratio) of children vocalising canonical or non canonical babbling of syllables

  4. Canonical babbling; 3.Consonant inventory

    Time frame: 12 months

    Consonant inventory is measured by the number of correct sounds produced

  5. Articulation: 1. Percent consonant correct (PCC)

    Time frame: 3 and 5 years

    Articulation is measured by the percentage of children vocalising the correct consonants

  6. Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors

    Time frame: 3 and 5 years

    Articulation is measured by the percentage of children vocalising correct consonants ( oral and non-oral) in the correct placement and manner

  7. Postoperative/long term complications

    Time frame: 48 hours and 30 days postoperatively

    Complications are measured by assessment for presence (yes or no) of the following:1.Dehiscence 2.Infection 3.Evidence of fistula

  8. Postoperative/long term complications

    Time frame: at 3 and 5 year follow up

    measured by assessment for presence (yes or no) or evidence of fistula

  9. Hearing: hearing level assessment

    Time frame: 12 months

    Assessment of hearing level by Tympanometry and abnormal transient otoacoustic emission (TEOAE)

  10. Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.

    Time frame: 3 and 5 years

    Hearing level is assessed by Puretone audiometry

  11. Hearing level assessment

    Time frame: 3 and 5 years

    Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound.

  12. Middle ear function

    Time frame: 12 months, 3 and 5 years

    Middle ear function is assessed by presence of flat line Tympanogram in at least one ear and or both ears

  13. Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,

    Time frame: 5 years

    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

  14. Dentofacial development; Maxillary arch constriction score

    Time frame: 5 years

    This outcome is assesed using modified Huddart/Bodenham scoring system which is a range from -24 to +8

  15. Growth assessment for nude weight

    Time frame: 12 months

    Growth is measured in Kg body weight in nude

  16. Growth Assessment for crown to heel length and occipitofrontal circumference

    Time frame: 12 months

    Assessment for crown to heel length and Occipitofrontal circumference are in centimetres.

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
Aug 13, 2021

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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