Clinical Trial: Timing of Primary Surgery for Cleft Palate

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Timing of Primary Surgery for Cleft Palate

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 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.


Detailed Summary:

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)

Sponsor: William Shaw

Current Primary Outcome: 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.


Original Primary Outcome: The primary outcome measure for the TOPS trial is insufficient velopharyngeal function age 5 years. [ Time Frame: 5 years ]

Current Secondary Outcome:

  • 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 e

    Original Secondary Outcome:

    • Insufficient velopharyngeal function at age 3 years; [ Time Frame: 3 years ]
    • Velopharyngeal composite score summary at age 3 years and 5 [ Time Frame: 5 years ]
    • Canonical babbling at age 12 months [ Time Frame: 12 months ]
    • Articulation at age 3 years and 5 years [ Time Frame: 5 years ]
    • Perioperative complications including fistulisation; [ Time Frame: peri operative ]
    • Audiological assessment at 12 months, 3 years and 5 years [ Time Frame: 5 years ]
    • Dentofacial development at 5 years. [ Time Frame: 5 years ]


    Information By: University of Manchester

    Dates:
    Date Received: October 9, 2009
    Date Started: July 2010
    Date Completion: September 2020
    Last Updated: March 29, 2017
    Last Verified: March 2017