Abstract
Background and aim Normal articulation before school start is a main objective in cleft palate treatment. The aim was to investigate if differences exist in consonant proficiency at age 5 years between children with unilateral cleft lip and palate (UCLP) randomized to different surgical protocols for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy.
Design Three parallel group, randomised clinical trials were undertaken as an international multicenter study by 10 cleft teams in five countries: Denmark, Finland, , Norway, Sweden and UK.
Methods Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with nonsyndromic UCLP. Speech audio and video recordings of 391 children (136 girls and 255 boys) were available and transcribed phonetically. The main outcome measure was Percent Consonants Correct (PCC) from blinded assessments.
Results In Trial 1, arm A showed statistically significant higher PCC scores (82%) than arm B (78%) (P=.045). No significant differences were found between prevalences in Trial 2, A: 79%, C: 82%; or Trial 3, A: 80%, D: 85%.
Across all trials, girls achieved better PCC scores, excluding s-errors, than boys (91.0% and 87.5%, respectively) (P=.01).
Conclusions PCC scores were higher in arm A than B in Trial 1, whereas no differences were found between arms in Trial 2 or 3. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae and speech therapy visits differed.
Design Three parallel group, randomised clinical trials were undertaken as an international multicenter study by 10 cleft teams in five countries: Denmark, Finland, , Norway, Sweden and UK.
Methods Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with nonsyndromic UCLP. Speech audio and video recordings of 391 children (136 girls and 255 boys) were available and transcribed phonetically. The main outcome measure was Percent Consonants Correct (PCC) from blinded assessments.
Results In Trial 1, arm A showed statistically significant higher PCC scores (82%) than arm B (78%) (P=.045). No significant differences were found between prevalences in Trial 2, A: 79%, C: 82%; or Trial 3, A: 80%, D: 85%.
Across all trials, girls achieved better PCC scores, excluding s-errors, than boys (91.0% and 87.5%, respectively) (P=.01).
Conclusions PCC scores were higher in arm A than B in Trial 1, whereas no differences were found between arms in Trial 2 or 3. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae and speech therapy visits differed.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of Plastic Surgery and Hand Surgery |
| Vol/bind | 1 |
| Udgave nummer | 51 |
| Sider (fra-til) | 38-51 |
| Antal sider | 13 |
| ISSN | 2000-656X |
| Status | Udgivet - 20 feb. 2017 |