Speech Symptoms of Velopharyngeal Insufficiency and the Incidence of Secondary Speech Surgery in 10-Year-Old Children With Unilateral Cleft Lip and Palate: Comparison of 2 Randomized Surgical Methods for Primary Palatal Surgery.

OBJECTIVE: To compare speech symptoms of velopharyngeal insufficiency (VPI) and incidence of secondary speech surgery in 10-year-old Finnish children with unilateral cleft lip and palate (UCLP) following primary palatal surgery using 2 surgical methods. DESIGN: Single center analysis within the Scandcleft multicenter randomized controlled trial of primary surgery for UCLP. MATERIALS AND METHODS: Patients comprised 79 nonsyndromic 10-year-old children with UCLP. Two randomized surgical methods were used in the primary palatal surgery: soft palate closure at 4 months and hard palate closure at 12 months (Arm A) and closure of both the soft and hard palate at 12 months (Arm C). Speech symptoms of VPI were analyzed from standardized video recordings by 2 experienced speech pathologists. The incidences of surgery for correcting VPI, fistula closure, and speech therapy were evaluated retrospectively from patient records. RESULTS: No differences in speech symptoms of VPI, need for VPI surgery or speech therapy were found between the surgical methods. Of all 79 children, 33% had had VPI surgery and 61% had speech therapy. The number of fistulas was significantly higher in Arm A (25%) than in Arm C (2%). Moderate to severe speech symptoms of VPI (hypernasality, continuous nasal air leakage, weak pressure consonants, and/or compensatory articulation) were found in 11% of the children. CONCLUSION: No differences were present between groups in speech symptoms of VPI or need for VPI surgery or speech therapy between the 2 surgical methods. One third of the children had undergone VPI surgery. Most of the children (89%) had good or relatively good speech.

[Treatment of cleft lip and palate in Finland]. / Huuli- ja suulakihalkioiden hoidon suuntaviivoja.

In Finland about 120 babies are born with cleft lip and palate per year. The largest group is those with isolated cleft palate (60%) and only one fourth have complete cleft lip and palate. The clefts are closed under one year of age. Clefts affect appearance, occlusion and speech and the final outcome can only be assessed at the end of the growth. Centralisation of services and a multidisciplinary team approach has a bigger influence on the final outcome than different treatment protocols, the comparative advantages of which remain unproven. Good documentation is important to assess the level of treatment outcomes.

Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 4. Speech outcomes in 5-year-olds - velopharyngeal competency and hypernasality.

BACKGROUND AND AIM: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP) operated on with different surgical methods 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, Sweden, Norway, 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 a non-syndromic UCLP. Speech audio and video recordings of 391 children (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments. RESULTS: There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%. CONCLUSIONS: No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed. TRIAL REGISTRATION: ISRCTN29932826.

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

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.

A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.

BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. METHOD: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. RESULTS: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years. CONCLUSION: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series. TRIAL REGISTRATION: ISRCTN29932826.