Outcome measures | Assessment schedule (age is corrected for gestational age) | |||||
Assessments | Postsurgery | 12 months | 3 years | 5 years | ||
48 hours | 30 days | |||||
Surgical complications | Dehiscence | √ | √ | |||
Infection | √ | √ | ||||
Evidence of fistula | √ | √ | √ | |||
Growth | Nude weight | √ | ||||
Crown to heel length | √ | |||||
Occipitofrontal circumference | √ | |||||
Canonical babbling | Canonical babbling present* | √ | ||||
Canonical babbling ratio* | √ | |||||
Consonant inventory* | √ | |||||
Velopharyngeal function | Velopharyngeal Composite Score summary (VPC sum) | √†‡ | ||||
Insufficient velopharyngeal function (VPC rate) | ä | æ | ||||
Velopharyngeal insufficiency symptoms | à | |||||
Articulation | Per cent consonant correct (PCC)† | √ | √ | |||
Per cent correct placement (PCP)† | √ | √ | ||||
Per cent correct manner (PCM)† | √ | √ | ||||
Non-oral consonant errors† | √ | √ | ||||
Oral consonant errors† | √ | √ | ||||
Hearing level | Abnormal Transient Otoacoustic Emission (TEOAE) | √ | ||||
Abnormal soundfield audiometry | √ | |||||
Abnormal pure tone audiometry in at least one ear** | √ | √ | ||||
Abnormal pure tone audiometry in both ears** | √ | √ | ||||
Severity of better ear** | √ | √ | ||||
Soundfield audiometry** | √ | √ | ||||
Middle ear function | Flat line Tympanogram in at least one ear | √ | √ | √ | ||
Flat line Tympanogram in both ear | √ | √ | √ | |||
Dentofacial development | Soft tissue ANB†† | √ | ||||
Maxillary Arch Constriction score‡‡ | √ | |||||
Others | DENVER II Developmental Assessment§§ | √ | ||||
Intelligibility in Context Scale Questionnaire for parents (ICS) | √ | |||||
Local Site questionnaire¶¶ | √ | √ |
Sources of speech assessments:
* Video of play interaction.
†TOPS picture naming test.
‡Nine-word string.
§Spontaneous speech.
¶:Spontaneous speech(retelling of bus story).
**If pure tone audiometry could not be performed, then soundfield audiometry will be performed.
††The angle between soft tissue nasion A point and B point on a profile photograph.
‡‡Maxillary Arch Constriction score is determined using modified Huddart/Bodenham scoring system.
§§DENVER II Developmental Assessment is carried out at the time of surgery.
¶¶ Local site questionnaire sent to local speech and language therapists outside TOPS research team to collect data on direct and indirect therapy given to the child in the intervals between assessment visits.