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Timing of Primary Surgery for Cleft Palate (TOPS)

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ClinicalTrials.gov Identifier: NCT00993551
Recruitment Status : Active, not recruiting
First Posted : October 12, 2009
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
University of Liverpool
National Institute of Dental and Craniofacial Research (NIDCR)
University of Copenhagen
Göteborg University
Information provided by (Responsible Party):
William Shaw, University of Manchester

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.


Condition or disease Intervention/treatment Phase
Cleft Palate Procedure: primary surgery for cleft palate Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Timing of Primary Surgery for Cleft Palate
Study Start Date : July 2010
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 12 month surgery
Infants will receive primary surgery at age 12 months using Sommerlad technique
Procedure: primary surgery for cleft palate
Surgery completed using the Sommerlad technique

Experimental: 6 month surgery
Infants will receive primary surgery at age 6 months using Sommerlad technique.
Procedure: primary surgery for cleft palate
Surgery completed using the Sommerlad technique




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993551


Locations
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Brazil
University of Sao Paulo
Bauru, Brazil
Denmark
Copenhagen Cleft Palate Centre
Copenhagen, Denmark
Århus Speech and Hearing Institute
Århus, Denmark
Norway
Helse Bergen HF
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Sweden
Göteborg University
Göteborg, Sweden
University of Linköping
Linköping, Sweden
Malmö University Hospital
Malmö, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umeå University
Umeå, Sweden
Uppsala University
Uppsala, Sweden
United Kingdom
Belfast Health and Social Care Trust
Belfast, United Kingdom
Birmingham Children's NHS Foundation Trust
Birmingham, United Kingdom
North Bristol NHS Foundation Trust
Bristol, United Kingdom
Edinburgh Hospital for Sick Children
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds University Hospitals NHS foundation Trust
Leeds, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Newcastle University Hospitals NHs Foundation Trust
Newcastle, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Abertawe Bro Morgannwg University Health Board
Swansea, United Kingdom
Sponsors and Collaborators
William Shaw
University of Liverpool
National Institute of Dental and Craniofacial Research (NIDCR)
University of Copenhagen
Göteborg University
Investigators
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Principal Investigator: William C Shaw, PhD/FDSRCS University of Manchester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William Shaw, Professor of Orthodontics Dentofacial Development, University of Manchester
ClinicalTrials.gov Identifier: NCT00993551     History of Changes
Other Study ID Numbers: 09-017-E
1U01DE018837-01A1 ( U.S. NIH Grant/Contract )
Sponsor Reference: 57201 ( Other Identifier: The University of Manchester (UK) )
NIHR Portfolio Reference 30200 ( Other Identifier: NIHR )
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by William Shaw, University of Manchester:
cleft palate
paediatric
pediatric
surgery
speech
velopharyngeal
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities