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.).

The impact of hearing loss on speech outcomes in 5-year-old children with cleft palate ± lip: A longitudinal cohort study.

OBJECTIVES: To investigate the impact of hearing loss (using longitudinal measurements of hearing) on speech outcomes at age 5 (5 years 0 months-5 years 11 months) in children born with cleft palate ± lip. Other variables which may impact upon the speech outcomes at age 5 in this population were also investigated. METHODS: A retrospective longitudinal cohort study of children, without a named syndrome, born with cleft palate ± lip, and treated at a Cleft Centre in the United Kingdom. Data collected from infancy to 5 years 11 months, included hearing test results from three specific time points (7 months-1 year 2 months [age A]; 2 years 0 months-2 years 11 months [age B]; 5 years 0 months-5 years 11 months [age C]) and speech outcome data at age 5 years (5 years 0 months-5 years 11 months). Hearing test results at each age were compared to identify how hearing changes with age. Correlations between hearing test results and speech outcomes at age 5 were analysed. RESULTS: Hearing loss was frequent but predominantly mild. There were no significant correlations between speech outcomes and hearing results at any age. Mild hearing loss remained prevalent at age 5, although a significant age-related hearing improvement was found. A significant relationship between cleft type and cleft speech characteristics was found (P < .001); children with Bilateral Cleft Lip and Palate achieved the poorest articulation outcomes. CONCLUSION: Although mild hearing loss was common in the cohort, there was no association between hearing loss and the speech outcomes investigated. In contrast, the type of cleft was significantly associated with the presence of cleft speech characteristics. Further longitudinal measurement of hearing is required to substantiate the findings of this study.

Assessing speech at three years of age in the cleft palate population: a scoping review of assessment practices.

BACKGROUND: There is no consensus in the UK regarding the types of speech samples or parameters of speech that should be assessed at 3 years of age in children with cleft palate ± cleft lip (CP±L), despite cleft units routinely assessing speech at this age. The standardization of assessment practices would facilitate comparisons of outcomes across UK cleft units; earlier identification of speech impairments-which could support more timely treatments; and more reliable recording of therapy impacts and surgical interventions. AIMS: To explore assessment practices used to assess speech in 3-year-old children with CP±L, including speech parameters, methods of assessment and the nature of the speech sample used. METHODS & PROCEDURES: A broad examination of the literature was undertaken through the use of a scoping review conducted in accordance with Joanna Briggs Institute guidelines. Search terms were generated from a preliminary search and then used in the main search (Medline, CINAHL, Embase, AMED and PsycINFO). MAIN CONTRIBUTION: A combination of approaches (medical, linguistic, developmental and functional) is required to assess CP±L speech at age 3. A developmental approach is recommended at this age, considering the complexity of speech profiles at age 3, in which typically developing speech processes may occur alongside cleft speech characteristics. A combined measure for both nasal emission and turbulence, and an overall measure for velopharyngeal function for speech, show potential for assessment at this age. Categorical ordinal scales are frequently used; the use of continuous scales has yet to be fully explored at age 3. Although single-word assessments, including a subset of words developed for cross-linguistic comparisons, are frequently used, more than one type of speech sample may be needed to assess speech at this age validly. The lack of consensus regarding speech samples highlights a need for further research into the types of speech samples 3-year-olds can complete; the impact of incomplete speech samples on outcome measures (particularly relevant at this age when children may be less able to complete a full sample); the impact of different speech samples on the validity of assessments; and the reliability of listener judgements. CONCLUSIONS & IMPLICATIONS: Whilst a medical model and linguistic approaches are often central in assessments of age-3 cleft speech, this review highlights the importance of developmental and functional approaches to assessment. Cross-linguistic single-word assessments show potential, and would facilitate the comparison of UK speech outcomes with other countries. Further research should explore the impact of different speech samples and rating scales on assessment validity and listener reliability.

Feed and Swaddle: An Alternative to Infant Sedation for Craniofacial Imaging.

OBJECTIVE: The gold standard for diagnosis of craniosynostosis is a clinical examination and motionless head computed tomography (CT). Computed tomography sedation is associated with increased cost, resource utilization, medical, and possible developmental risks. This study investigates whether a "feed and swaddle" protocol can be used to achieve diagnostic quality craniofacial imaging without the use of infant sedation. DESIGN: Prospective cohort study. SETTING: Tertiary academic medical center. PATIENTS: Ninety patients <18 months of age undergoing evaluation for craniosynostosis from 2012 to 2018. INTERVENTIONS: A feed and swaddle protocol. MAIN OUTCOME MEASURES: Diagnostic level imaging without the use of infant sedation. RESULTS: Eighty-five (94%) achieved a diagnostic quality craniofacial CT scan using the "feed and swaddle" method. Mean patient age was 24.0 ± 10.0 weeks. Craniosynostosis was diagnosed in 74% of patients. Mean age of patients with successful completion of a CT scan was 23.7 ± 9.6 weeks, compared to 27.2 ± 17.1 weeks for unsuccessful completion. Mean weight for the successful group was 15.6 ± 2.9 pounds and 15.9 ± 2.5 pounds for the unsuccessful group. Mean travel distance was 59.2 ± 66.5 miles for successful patients and 66.5 ± 61.5 miles for unsuccessful patients. For the unsuccessful patients, there were no delays in surgical planning or scheduling. CONCLUSION: The "feed and swaddle" protocol described here is an effective alternative to infant sedation for motionless craniofacial CT imaging.