Timing of Primary Surgery for Cleft Palate.

BACKGROUND: Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown. METHODS: We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth. RESULTS: We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up. CONCLUSIONS: Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).

An Ultrasound Investigation of Tongue Dorsum Raising in Children with Cleft Palate +/- Cleft Lip.

OBJECTIVE: This study aimed to determine whether increased raising of the back of the tongue is evident in children with repaired cleft palate with or without cleft lip (CP+/-CL). We hypothesized that children with CP+/-CL would show increased raising of the tongue dorsum, a compensatory pattern. METHOD: Secondary data analysis of mid-sagittal ultrasound tongue imaging data from 31 children with CP+/-CL and 29 typically developing children were used. We annotated the consonants /ʃ, t, s, k/ at the point of maximum constriction in an /aCa/ environment. Children with CP+/-CL said the tokens 10 times, typically developing children said them once. We automatically fitted splines to the tongue contour and extracted the Dorsum Excursion Index (DEI) for each consonant. This metric measures the relative use of the tongue dorsum, with more posterior consonants having higher values. We compared DEI values across groups and consonants using a linear mixed effects model. DEI was predicted by the interaction of consonant (baseline: /ʃ/) and speaker type (baseline: TD), including by-speaker random slopes for consonant and random intercepts for speaker. RESULTS: Overall DEI was not higher in children with CP+/-CL compared to typically developing children. Between groups the only significant difference was the position of /k/ relative to /ʃ/, where the difference between these two consonants was smaller in the children with CP+/-CL. CONCLUSIONS: There was no support for the hypothesis that increased raising of the tongue dorsum is a common characteristic in children with repaired CP+/-CL. However, individual children may present with this pattern.

Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate.

BACKGROUND: Children with cleft lip and palate can continue to have problems producing clear speech after surgery. This can lead to social, emotional, and educational challenges. Typical treatment involves teaching children the correct tongue movements to produce speech sounds. This is known as articulation intervention. However, this intervention is challenging because the tongue is hidden from view and movements are difficult to see and describe. This pilot randomized control trial will try a new treatment, ultrasound visual biofeedback (U-VBF) versus standard articulatory intervention for children with cleft lip and palate, as comparison. Feasibility outcomes will be determined. METHODS/DESIGN: The Sonospeech project will enroll up to 40 children with cleft lip and palate aged 4;6 to 16 in a mixed-methods randomized controlled trial with blinded assessors. Children will receive either six sessions of U-VBF or articulation intervention. The primary goals of this pilot are to assess the feasibility and inform the design of a full-scale RCT of U-VBF for children with cleft speech characteristics. This will be achieved by determining the following outcome measures: recruitment/attrition rates; measures of pre-post follow-up completion; and acceptability of the randomization and interventions to families. DISCUSSION: Larger trials of speech interventions for children with cleft lip and palate are needed. This pilot/feasibility study will determine whether a larger randomized control trial comparing ultrasound and articulation interventions is feasible. TRIAL REGISTRATION: ISRCTN, ISRCTN17441953 . Registered 22 March 2021. See Table 2 in Appendix 1 for all items.

The Impact of Real-Time Articulatory Information on Phonetic Transcription: Ultrasound-Aided Transcription in Cleft Lip and Palate Speech.

OBJECTIVE: This study investigated whether adding an additional modality, namely ultrasound tongue imaging (UTI), to perception-based phonetic transcription impacted on the identification of compensatory articulations and on interrater reliability. PATIENTS AND METHODS: Thirty-nine English-speaking children aged 3-12 years with cleft lip and palate (CLP) were recorded producing repetitions of /aCa/ for all places of articulation with simultaneous audio recording and probe-stabilized ultrasound (US). Three types of transcriptions were performed: (1) descriptive observations from the live US by the clinician recording the data, (2) US-aided transcription (UA) by two US-trained clinicians, and (3) traditional phonetic transcription by two CLP specialists from audio recording. We compared the number of consonants identified as in error by each transcriber and then classified errors into eight different subcategories. RESULTS: Both UA and traditional transcription yielded similar error detection rates; however, these were significantly higher than the observations recorded live in the clinic. Interrater reliability for the US transcribers was substantial (κ = 0.65) compared to moderate (κ = 0.47) for the traditional transcribers. US transcribers were more likely to identify covert errors such as double articulations and retroflexion than the audio-only transcribers. CONCLUSION: UTI is a useful complement to traditional phonetic transcription for CLP speech.