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Timing of Primary Surgery for Cleft Palate (TOPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Liverpool
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
William Shaw, University of Manchester
ClinicalTrials.gov Identifier:
NCT00993551
First received: October 9, 2009
Last updated: March 29, 2017
Last verified: March 2017
  Purpose

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 specified technique, at age 6 months, when compared to surgery using the same technique age 12 months, improves speech development. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes(age 5) and secondary outcomes.


Condition Intervention
Cleft Palate
Procedure: primary surgery for cleft palate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Timing of Primary Surgery for Cleft Palate

Resource links provided by NLM:


Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • 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:
  • Insufficient velopharyngeal function [ Time Frame: 3 years ]
    unit of measure to be confirmed. It will be measured by either "yes" or "no" or a 3 point scale; insufficient, marginal or sufficient

  • Canonical babbling measured by canonical babbling present [ Time Frame: 12 months ]
    unit of measure: Yes or No c. Oral consonant errors

  • Canonical babbling measured by canonical babbling ratio [ Time Frame: 12 months ]
    unit of measure: % of canonical babbling

  • Canonical babbling measured by consonant inventory [ Time Frame: 12 months ]
    unit of measure: number of correct sounds produced

  • Articulation [ Time Frame: 3 years ]
    unit of measure: % consonant correct (PCC)

  • Articulation [ Time Frame: 3 years ]
    unit of measure: % correct placement (PCP)

  • Articulation [ Time Frame: 3 years ]
    unit of measure: % correct manner (PCM)

  • Articulation [ Time Frame: 3 years ]
    unit of measure: % of children with non-oral consonant errors

  • Articulation [ Time Frame: 5 years ]
    unit of measure: % consonants correct (PCC)

  • Articulation [ Time Frame: 5 years ]
    unit of measure: % of children with non-oral consonant errors

  • Articulation [ Time Frame: 5 years ]
    unit of measure: % of children with oral consonant errors

  • Postoperative/long term complications measured by dehiscence [ Time Frame: up to 48 hours post operation ]
    unit of measure: yes or no for dehiscence present

  • Postoperative/long term complications measured by dehiscence [ Time Frame: up to 30 days post operation ]
    unit of measure: yes or no for dehiscence present

  • Postoperative/long term complications measured by infection [ Time Frame: up to 48 hours post operation ]
    unit of measure: yes or no for infection present

  • Postoperative/long term complications measured by infection [ Time Frame: up to 30 days post operation ]
    unit of measure: yes or no for infection present

  • Postoperative/long term complications measured by evidence of fistula [ Time Frame: up to 30 days post operation ]
    unit of measure: yes or no for fistula present

  • Postoperative/long term complications measured by evidence of fistula [ Time Frame: 3 years ]
    unit of measure: yes or no for fistula present

  • Postoperative/long term complications measured by evidence of fistula [ Time Frame: 5 years ]
    unit of measure: yes or no for fistula present

  • Hearing level [ Time Frame: 12 months ]
    unit of measure: yes or no by Abnormal Transient Otoacoustic Emission (TEOAE)

  • Hearing level [ Time Frame: 12 months ]
    unit of measure: yes or no by Abnormal Soundfield audiometry

  • Hearing level [ Time Frame: 3 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear

  • Hearing level [ Time Frame: 3 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in both ears

  • Hearing level [ Time Frame: 3 years ]
    unit of measure: Severity of better ear categorised as normal, mild, moderate or severe

  • Hearing level [ Time Frame: 5 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear

  • Hearing level [ Time Frame: 5 years ]
    unit of measure: yes or no by Abnormal Puretone audiometry in both ears

  • Hearing level [ Time Frame: 5 years ]
    unit of measure: Severity of better ear categorised as normal, mild, moderate, severe or profound

  • Middle ear function [ Time Frame: 12 months ]
    unit of measure: yes or no by flat line Tympanogram in at least one ear

  • Middle ear function [ Time Frame: 3 years ]
    unit of measure: yes or no by flat line Tympanogram in at least one ear

  • Middle ear function [ Time Frame: 5 years ]
    unit of measure: yes or no by flat line Tympanogram in at least one ear

  • Middle ear function [ Time Frame: 12 months ]
    unit of measure: yes or no by flat line Tympanogram in both ears

  • Middle ear function [ Time Frame: 3 years ]
    unit of measure: yes or no by flat line Tympanogram in both ears

  • Middle ear function [ Time Frame: 5 years ]
    unit of measure: yes or no by flat line Tympanogram in both ears

  • Dentofacial development [ Time Frame: 5 years ]
    unit of measure: Degrees (0-360) soft tissue ANB (the angle between soft tissue nasion, A point and B point on a profile photograph)

  • Dentofacial development [ Time Frame: 5 years ]
    unit of measure: Maxillary arch constriction score using Modified Huddart/Bodenham 25 point scoring system (-22 to +2)

  • Growth [ Time Frame: 12 months ]
    unit of measure: nude weight in grams (g)

  • Growth [ Time Frame: 12 months ]
    unit of measure: crown to heel length measure in centimetres (cm)

  • Growth [ Time Frame: 12 months ]
    unit of measure: occipitofrontal circumference in centimetres (cm)


Enrollment: 558
Study Start Date: July 2010
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 month surgery
Infants will receive primary surgery at age 12 months using a standardized 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 a standardized technique.
Procedure: primary surgery for cleft palate
Surgery completed using the Sommerlad technique

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 (dental impressions and photographs)
  Eligibility

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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993551

Locations
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
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
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)
Investigators
Principal Investigator: William C Shaw University of Manchester
  More Information

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 ( US NIH Grant/Contract Award Number )
Sponsor Reference: 57201
NIHR Portfolio Reference 30200 ( Other Identifier: NIHR )
Study First Received: October 9, 2009
Last Updated: March 29, 2017

Keywords provided by University of Manchester:
cleft palate
paediatric
pediatric
surgery
speech
velopharyngeal

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2017