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 ]
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