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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 5. Speech outcomes in 5-year-olds - consonant proficiency and errors

posted on 20.02.2017 by Elisabeth Willadsen, Anette Lohmander, Christina Persson, Inger Lundeborg, Suvi Alaluusua, Ragnhild Aukner, Anja Bau, Maria Boers, Melanie Bowden, Julie Davies, Berit Emborg, Christina Havstam, Christine Hayden, Gunilla Henningsson, Anders Holmefjord, Elina Hölttä, Mia Kisling-Møller, Lillian Kjøll, Maria Lundberg, Eilish McAleer, Jill Nyberg, Marjukka Paaso, Nina Helen Pedersen, Therese Rasmussen, Sigvor Reisæter, Helene Søgaard Andersen, Antje Schöps, Inger-Beate Tørdal, Gunvor Semb

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) randomised 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 multicentre study by 10 cleft teams in five countries: Denmark, Finland, Norway, Sweden, and the 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 non-syndromic 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 Trials 2 or 3. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed.

Trial registration: ISRCTN29932826.