Timing of Primary Surgery for Cleft Palate (TOPS)

• 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.
  
  

• 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)
  
  

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)