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.

Outcomes of Primary Furlow Double-Opposing Z-plasty for the Treatment of Symptomatic Submucous Cleft Palate.

BACKGROUND: Submucous cleft palate (SMCP) requires surgical repair if symptomatic. The Furlow double-opposing Z-plasty is the preferred method in Helsinki cleft center. AIMS: To assess the efficacy and complications of Furlow Z-plasty in the treatment of symptomatic SMCP. METHODS: This retrospective study reviewed documentation of 40 consecutive patients with symptomatic SMCP who underwent primary Furlow Z-plasty by 2 high-volume cleft surgeons at a single center between 2008 and 2017. Patients underwent perceptual and instrumental evaluation of velopharyngeal function (VPF) by speech pathologists preoperatively and postoperatively. RESULTS: The median age at Furlow Z-plasty was 4.8 years (SD 2.6, range 3.1-13.6). The overall success rate, including postoperative competent or borderline competent VPF, was 83%, and 10% required secondary surgery for residual velopharyngeal insufficiency. The success rate was 85% in nonsyndromic, and 67% in syndromic patients with no significant difference ( P =0.279). Complications arose in only 2 (5%) patients. No children were found to have obstructive sleep apnea postoperatively. CONCLUSION: Furlow primary Z-plasty is a safe and effective operation for symptomatic SMCP with a success rate of 83% with only 5% rate of complications.

Diagnosing and Managing Velopharyngeal Insufficiency in Patients With Cleft Palate After Primary Palatoplasty.

Velopharyngeal insufficiency (VPI) after palatoplasty is caused by improper anatomy preventing velopharyngeal closure and manifests as a hypernasal resonance, audible nasal emissions, weak pressure consonants, compensatory articulation, reduced speech loudness, and nostril or facial grimacing. A multidisciplinary team using multimodal instruments (speech analysis, nasoendoscopy, videofluoroscopy, nasometry, and magnetic resonance imaging) to evaluate velopharyngeal function should manage these patients. Careful monitoring of velopharyngeal function by a speech pathologist remains paramount for early identification of VPI and the perceptual assessment should follow a standardized protocol. The greatest methodology problem in CLP studies has been the use of highly variable speech samples making comparison of published results impossible. It is hoped that ongoing international collaborative efforts to standardize procedures for collection and analysis of perceptual data will help this issue. Speech therapy is the mainstay treatment for velopharyngeal mislearning and compensatory articulation, but it cannot improve hypernasality, nasal emissions, or weak pressure consonants, and surgery is the definitive treatment for VPI. Although many surgical methods are available, there is no conclusive data to guide procedure choice. The goal of this review article is to present a review of established diagnostic and management techniques of VPI.

Le Fort I Osteotomy in Cleft Patients: Maxillary Advancement and Articulation.

BACKGROUND: Maxillary advancement may affect speech in cleft patients. AIMS: To examine whether the amount of maxillary advancement and preoperativecephalometric skeletal and dentoalveolar relationships are associated with articulation errors of the Finnish alveolar consonants /s/, /l/, and /r/ in cleft patients. MATERIALS AND METHODS: Fifty-seven nonsyndromic cleft patients who underwent Le Fort I or bimaxillary osteotomies were evaluated retrospectively. Pre- and post-operative lateral cephalometric radiographs and standardized speech video recordings were analyzed. The Aspin-Welch unequal variance t test, Student t test sign test, intraclass correlation and Kappa statistics were used in the statistical analyses. RESULTS: The mean advancement of the maxilla (point A) was 4.65 mm horizontally (range -2.80 to 11.30) and -3.82 mm vertically (range -14.20 to 3.90). The overall articulation (especially the sounds /s/ and /l/) improved significantly postoperatively, but the amount of maxillary advancement did not affect the articulation. The preoperative mean percentages of /s/, /l/, and /r/ errors were 32%, 33%, 46% and the postoperative percentages 23%, 19%, 40%, respectively. Preoperative articulation errors of /s/ were related to palatal inclination of the upper incisors. CONCLUSIONS: Orthognathic surgery may improve articulation errors. The amount of maxillary advancement is not related to the improvement.

Palatal Re-Repair With Z-Plasty in Treatment of Velopharyngeal Insufficiency of Syndromic and Nonsyndromic Patients With Cleft Palate.

BACKGROUND: Velopharyngeal insufficiency (VPI) often results from palatal shortening or insufficient levator function after cleft palate repair. AIMS: To assess the efficacy of palatal re-repair with Z-plasty in treatment of VPI for patients with isolated cleft palate (ICP). METHODS: This retrospective analysis comprised 130 consecutive patients who had ICP with VPI that required Z-plasty as secondary surgery between 2008 and 2017. Pre- and post-operative evaluation of velopharyngeal function was done perceptually and instrumentally by Nasometer. RESULTS: Median patient age at Z-plasty was 6.8 years (range 3.0-20.1). Of the 130 patients, preoperatively VPI was severe in 73 (56%), mild-to-moderate in 55 (42%), and borderline in 2 (2%). Postoperatively, 105 (81%) of patients achieved adequate (normal or borderline) velopharyngeal competence and 16 (12%) required second operation for residual VPI. The success rate was 84% in nonsyndromic patients, 79% in nonsyndromic Pierre Robin sequence patients, and 58% in syndromic patients. In syndromic children, the speech outcome was significantly worse than in nonsyndromic children (P = 0.014). Complications included wound healing problems in 3 patients (2%), mild infection in 1 patient (1%), postoperative bleeding in 1 (1%), and postoperative fistula in 2 (2%). CONCLUSION: Palatal re-repair with Z-plasty is a safe operation for VPI correction in patients with ICP with a success rate of 81%. In syndromic patients, the procedure did not seem to work as well as in nonsyndromic patients.

Palatal Re-Repair With Double-Opposing Z-Plasty in Treatment of Velopharyngeal Insufficiency of Patients With Unilateral Cleft Lip and Palate.

BACKGROUND: Velopharyngeal insufficiency (VPI) is a common problem after cleft palate repair that is often related to palatal shortening and insufficient levator reconstruction. For VPI correction in our cleft center, palatal re-repair with double-opposing Z-plasty is the standard operation. AIMS: To assess the efficacy of double-opposing Z-plasty in treatment of VPI after primary surgery for unilateral cleft lip and palate (UCLP). METHODS: This retrospective analysis comprised 109 consecutive UCLP patients born between 1997 and 2014 with VPI that required re-operation, and were operated on by 2 highvolume cleft surgeons, followed by perceptual and instrumental (Nasometer) evaluation of velopharyngeal competence (VPC). RESULTS: Preoperatively, VPI was severe in 96% (105 of 109) and mild-to-moderate in 4% (4 of 109). Median age at surgery was 5.6 years (range 2.8-21.9). Postoperatively, 84% of patients achieved adequate VPC: 65% (71 of 109) were competent and 19% (21 of 109) borderline competent. Postoperative adequate VPC was 89% (70 of 79) in nonsyndromic Finnish patients, 50% (4 of 8) in syndromic patients, and 82% (18 of 22) in adoption children. Compared to Finnish nonsyndromic patients, patients with syndrome had more residual VPI (P = 0.003), but no statistically significant difference existed for adoption patients (P = 0.251). Complications of the double-opposing Z-plasty included hemorrhage, postoperative mild airway obstruction, and wound-healing problems, each arising in 2 (1.8%) patients. Fourteen (13%) patients needed a second VPI operation. CONCLUSION: Double-opposing Z-plasty seems to be a good and safe treatment option for VPI in patients with previously repaired UCLP with a success rate of 84%.

Speech of Patients With Unilateral Complete Cleft Lip and Palate: Comparison of Three Different Surgical Protocols for Primary Repair.

BACKGROUND AND AIMS: Between 1997 and 2014, 3 protocols have been used in out cleft unit for primary repair of unilateral cleft lip and palate. During the Scandcleft randomized controlled trial closing the soft palate and lip at 4 months and the hard palate at 12 months (Protocol 1) was compared with closing the entire palate at 12 months (Protocol 2). Protocol 3 comprises closure of the lip and hard palate with a vomer flap at 4 months and the soft palate at 10 months. The purpose of this study was to compare subsequent velopharyngeal competence at age of 3 and 5 years. PATIENTS AND METHODS: The study consisted of 160 non-syndromatic patients with a unilateral cleft lip and palate. Protocol 3 was retrospectively compared with Protocols 1 and 2 within the previously published Scandcleft study. RESULTS: At 3 years of age, normal or borderline competent velopharyngeal function was found in 68% of patients in Protocol 1, 74% of patients in Protocol 2, and 72% of patients in Protocol 3. At 5 years of age, the corresponding figures were 84%, 82%, and 92%. 21% of patients in Protocol 1, 4% in Protocol 2, and 23% in Protocol 3 had palatal reoperations before the age of 5 years. CONCLUSION: No significant differences emerged in velopharyngeal competence at age 3 years between the 3 protocols. Palatal reoperations were performed earlier in patient groups 1 and 3, explaining the difference in the velopharyngeal competence rate at the 5-year time-point.

Scandcleft Project Trial 2-Comparison of Speech Outcome in 1- and 2-Stage Palatal Closure in 5-Year-Olds With UCLP.

OBJECTIVE: To investigate in-depth speech results in the Scandcleft Trial 2 with comparisons between surgical protocols and centers and with benchmarks from peers without cleft palate. DESIGN: A prospective randomized clinical trial. SETTING: Two Swedish and one Finnish Cleft Palate center. PARTICIPANTS: One hundred twelve participants were 5-years-old born with unilateral cleft lip and palate randomized to either lip repair and soft palate closure at 4 months and hard palate closure at 12 months or lip repair at 3 to 4 months (Arm A), or a closure of both the soft and hard palate at 12 months (Arm C). MAIN OUTCOME MEASURES: A composite measure dichotomized into velopharyngeal competency (VPC) or velopharyngeal incompetency (VPI), overall assessment of velopharyngeal function (VPC-Rate), percentage of consonants correct (PCC score), and consonant errors. In addition, number of speech therapy visits, average hearing thresholds, and secondary surgeries were documented to assess burden of treatment. RESULTS: Across the trial, 53.5% demonstrated VPC and 46.5% VPI with no significant differences between arms or centers. In total, 27% reached age-appropriate PCC scores with no statistically significant difference between the arms. The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors. Number of speech therapy visits was significantly higher in the Finnish center. CONCLUSION: At age 5, poor speech outcomes with some differences between participating centers were seen but could not be attributed to surgical protocol. As one center had very few participants, the results from that center should be interpreted with caution.

Validity of auditory perceptual assessment of velopharyngeal function and dysfunction - the VPC-Sum and the VPC-Rate.

Overall weighted or composite variables for perceptual auditory estimation of velopharyngeal closure or competence have been used in several studies for evaluation of velopharyngeal function during speech. The aim of the present study was to investigate the validity of a composite score (VPC-Sum) and of auditory perceptual ratings of velopharyngeal competence (VPC-Rate). Available VPC-Sum scores and judgments of associated variables (hypernasality, audible nasal air leakage, weak pressure consonants, and non-oral articulation) from 391 5-year olds with repaired cleft palate (the Scandcleft project) were used to investigate content validity, and 339 of these were compared with an overall judgment of velopharyngeal competence (VPC-Rate) on the same patients by the same listeners. Significant positive correlations were found between the VPC-Sum and each of the associated variables (Cronbachs alpha 0.55-0.87, P < 0.001), and a moderately significant positive correlation between VPC-Sum and VPC-Rate (Rho 0.698, P < 0.01). The latter classified cases well when VPC-Sum was dichotomized with 67% predicted velopharyngeal competence and 90% velopharyngeal incompetence. The validity of the VPC-Sum was good and the VPC-Rate a good predictor, suggesting possible use of both measures depending on the objective.

How Early Can We Predict the Need for VPI Surgery?

Velopharyngeal dimensions change as a child with cleft palate (CP) grows. The aim of this study was to assess if the decision for velopharyngeal insufficiency (VPI) surgery can be made by the age of 3 years among CP children with moderate-to-severe VPI. In addition, we sought to clarify if speech therapy before VPI surgery is beneficial for VPI speech characteristics. Methods: This retrospective study reviewed documentation of children with moderate-to-severe VPI at age 3 years who did not undergo VPI surgery until age 5 years. Based on the national cleft register, 959 patients with syndromic and nonsyndromic CP were treated by the craniofacial team at Helsinki University Hospital, Finland between 2000 and 2014. Eighty-six patients fulfilled the study inclusion criteria. The speech pathologist evaluated velopharyngeal function at age 3, 5, and 8 years. Results: Of the 86 children presenting with moderate-to-severe VPI at age 3 years, 94% still had moderate-to-severe VPI at age 5 years, even though speech therapy was offered to 77%. Of those whose velopharyngeal function improved by age 5 years, function regressed to incompetent over time. Overall, 93% underwent VPI surgery and 82% underwent VPI surgery between ages 5 and 8 years. Only 23% at age 8 years still had moderate-to-severe VPI. Speech therapy alone did not improve VPI speech characteristics. Conclusions: Moderate-to-severe VPI did not improve from 3 to 5 years or improved but subsequently relapsed. This suggests that the decision for VPI surgery can be made for children aged 3 years with moderate-to-severe VPI.

Speech Characteristics and Oromyofunctional Outcomes in Two Bimaxillary Face Transplantation Patients in Helsinki.

OBJECTIVES/HYPOTHESIS: Facial functional restoration is one of the main goals in face transplantation. We report the oromyofacial function outcomes of two bimaxillary face transplantation (FT) patients in Helsinki. STUDY DESIGN: Outcome Study. METHODS: Two male patients, aged 34 and 59, had severe functional facial disabilities following self-inflicted gunshot injuries sustained to their mid and lower faces several years earlier. Both underwent tooth-bearing maxillomandibular face transplantation in 2016 and 2018. We collected data regarding speech, swallowing, sensory recovery, motor recovery, and olfaction prior to transplantation. Patient charts were reviewed from the follow-up period of 4 and 2 years, respectively. RESULTS: Speech intelligibility, acceptability, and articulation continued to improve during follow-up for both patients. Voice quality and resonance were mainly normal at last follow-up. Swallowing improved once lip occlusion was regained, with only minor aspiration evident on videofluorography. Both patients had significant improvement in facial mimic muscle function after FT. The first patient who only had buccal sensory nerves connected has only recovered protective facial sensation, whereas our second patient with buccal, infraorbital, and alveolar nerves connected has almost complete facial two-point discrimination. CONCLUSION: Both patients have regained satisfactory facial sensory and motor function. Sensory recovery seems to be faster and more precise if multiple sensory nerve coaptations are performed. Swallowing and speech have continued to improve over time although not reaching the level of the normal population. We demonstrate how speech-corrective surgery can safely be performed in a FT patient and can improve speech recovery. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2643-E2649, 2021.

The effect of maxillary advancement on articulation of alveolar consonants in cleft patients.

INTRODUCTION: Maxillary advancement may affect speech in cleft patients. The aim of this study was to evaluate the effect of maxillary advancement on Finnish alveolar consonants /s/, /l/, and /r/ in cleft patients. MATERIALS AND METHODS: Fifty-nine Finnish-speaking nonsyndromic cleft patients, who had undergone Le Fort I or bimaxillary osteotomies, were evaluated retrospectively Production of the Finnish alveolar consonants /s/, /l/, and /r/ was assessed from pre- and postoperative standardized video recordings by two experienced speech pathologists. McNemar's test was used in the statistical analyses. Kappa statistics were calculated to assess reliability. RESULTS: The patients included 35 females and 24 males with CP (n = 12), UCLP (n = 31), and BCLP (n = 16). There was a significant improvement in /s/ and /l/ sounds after maxillary advancement (p = 0.039 and p = 0.002, respectively). The preoperative mean percentage of /s/ errors was 34%; postoperatively it was 20%. /L/ was misarticulated preoperatively by 34% of the patients and postoperatively by 19%. /R/ was misarticulated preoperatively by 47% of the patients and postoperatively by 42%. The level of mild articulation errors rose from 25% to 31%, while severe articulation errors decreased from 37% to 25%. The reliabilities were good. CONCLUSION: When planning orthognathic surgery in cleft patients with maxillary retrusion and articulation errors, advancement of the maxilla might be a means for improving articulation of /s/ and /l/.

Le Fort I osteotomy in cleft patients: Maxillary advancement and velopharyngeal function.

BACKGROUND: Maxillary advancement may affect speech in cleft patients. AIMS: To evaluate whether the amount of maxillary advancement in Le Fort I osteotomy affects velopharyngeal function (VPF) in cleft patients. METHODS: Ninety-three non-syndromic cleft patients (51 females, 42 males) were evaluated retrospectively. All patients had undergone a Le Fort I or bimaxillary (n = 24) osteotomy at Helsinki Cleft Palate and Craniofacial Center. Preoperative and postoperative lateral cephalometric radiographs were digitized to measure the amount of maxillary advancement. Pre- and postoperative speech was assessed perceptually and instrumentally by experienced speech therapists. Student's t-test and Mann-Whitney's U-test were used in the statistical analyses. Kappa statistics were calculated to assess reliability. RESULTS: The mean advancement of A point was 4.0 mm horizontally (range: -2.8-11.3) and 3.9 mm vertically (range -14.2-3.9). Although there was a negative change in VPF, the amount of maxillary horizontal or vertical movement did not significantly influence the VPF. There was no difference between the patients with maxillary and bimaxillary osteotomy. CONCLUSIONS: The amount of maxillary advancement does not affect the velopharyngeal function in cleft patients.

The effects of Le Fort I osteotomy on velopharyngeal function in cleft patients.

INTRODUCTION: Maxillary advancement may affect speech in cleft patients. The aim of this study was to evaluate whether preoperative velopharyngeal (VP) function and cleft type can predict VP function after a Le Fort I maxillary osteotomy. MATERIALS AND METHODS: One hundred consecutive nonsyndromic cleft patients (54 females, 64 males) who underwent Le Fort I osteotomies were retrospectively evaluated. Pre- and postoperative VP function was assessed perceptually and instrumentally by a Nasometer. A five-point scale was used to rate velopharyngeal insufficiency symptoms (VPI 0-4). To assess reliability, 30 video recordings were re-evaluated. RESULTS: Preoperatively, 89% of patients had normal or insignificant VPI (0-1), and only 3% had moderate VPI (3). Postoperatively, 77% of patients had VPI values of 0-1 and 14% had moderate to severe VPI values (VPI 3-4). A positive correlation was found between pre- and postoperative VPI scores, whereas the cleft type did not affect speech results. Patients with a preoperatively normal VPI (0) were not at risk for postoperative velopharyngeal incompetence. CONCLUSIONS: There was an overall significant negative change in speech after a Le Fort I osteotomy. At-risk patients presented with borderline (1) or more severe VPI (2 and 3) preoperatively.

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.