Babbling in extremely premature infants at 12 months corrected age.

Babbling is an important precursor to speech in infancy, and deviations from the typical babbling development can predict later difficulties in speech, language, and communication. This cross-sectional study aimed to investigate babbling and early speech in Swedish extremely premature infants. Samples of babbling were collected from 20 extremely premature infants (EPT group) at the corrected age of 12 months. Data collection was home-based and consisted of an audio-video recording of each infant playing with a parent. Presence of canonical babbling (CB), and three oral stop variables distinctive of typical babbling, and consonant inventory were assessed. The assessment was performed during a standardised observation of babbling. Data from the EPT group were compared to previously collected data of a reference group of 20 10-month-old infants without known medical diagnoses. The results showed that the EPT group had a lower proportion of infants producing CB, and that they used a significantly smaller consonant inventory compared to the reference group. Although not statistically significant, oral stops were less frequently found in the EPT group. The findings of a restricted consonant inventory and low proportion of CB in the EPT group are not surprising considering that the group has been found to be at risk of speech and language delay in toddlerhood. Still, further research is needed to explore whether babbling at 12 months can predict speech and language skills at an older age in extremely premature infants.

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.).

Models for Predicting Velopharyngeal Competence Based on Speech and Resonance Errors and Velopharyngeal Area Estimation.

OBJECTIVE: To develop tools for predicting velopharyngeal competence (VPC) based on auditory-perceptual assessment and its correlation with objective measures of velopharyngeal orifice area. DESIGN: Methodological study. PARTICIPANTS AND METHODS: Sixty-two patients with repaired cleft palate, aged 6 to 45 years, underwent aerodynamic evaluation by means of the pressure-flow technique and audiovisual recording of speech samples. Three experienced speech-language pathologists analysed the speech samples by rating the following resonance, visual, and speech variables: hypernasality, audible nasal air emission, nasal turbulence, weak pressure consonants, facial grimacing, active nonoral errors, and overall velopharyngeal competence. The correlation between the perceptual speech variables and velopharyngeal orifice area estimates was analysed with Spearman's correlation coefficient. Two statistical models (discriminant and exploratory) were used to predict VPC based on the orifice area estimates. Sensitivity and specificity analyses were performed to verify the clinical applicability of the models. RESULTS: There was a strong correlation between VPC (based on the orifice area estimates) and each speech variable. Both models showed 88.7% accuracy in predicting VPC. The sensitivity and specificity for the discriminant model were 92.3% and 97.2%, respectively, and 96.2% and 94.4% for the exploratory model. CONCLUSION: Two predictor models based on ratings of resonance, visual, and speech variables and a simple calculation of a composite variable, SOMA (Eng. "sum"), were developed and found to be efficient in predicting VPC defined by orifice estimates categories based on aerodynamic measurements. Both tools may contribute to the diagnosis of velopharyngeal dysfunction in clinical practice.

Asking parents about babbling at 10 months produced valid answers but did not predict language screening result 2 years later.

AIM: We evaluated the concurrent and predictive validity of questions to parents of 10-month-old children about babbling. METHODS: Children with at least one native Swedish-speaking parent were eligible for inclusion in this prospective longitudinal study. The parents were asked three questions about babbling at a routine healthcare visit. If parents reported a lack of canonical babbling (CB), children were assessed by a speech and language pathologist to evaluate the questions' concurrent validity. We then examined whether the babbling questions predicted which children would fail the routine language screening at 2.5/3 years. RESULTS: Fifteen of the 1126 children lacked CB according to the parent responses and the expert assessment confirmed 12 of these cases, providing a concurrent validity of 80%. The sensitivity to predict routine language screening was 8% (95% confidence interval 3-17), and the positive predictive value was 40% (95% confidence interval 20%-65%). However, only six of the children lacking CB at 10 months were among the 71 children who failed later language screening. CONCLUSION: This study suggests that the babbling questions could be included in the 10-month surveillance at the child health services as valid measures of babbling development, but they cannot predict language screening result at 2.5/3 years.

On the Benefits of Speech-Language Therapy for Individuals Born With Cleft Palate: A Systematic Review and Meta-Analysis of Individual Participant Data.

PURPOSE: Cleft lip and/or palate (CLP) is a common birth defect, and after reconstructive surgery, about 50% of children at 5 years of age have speech deviations and are referred to speech-language therapy (SLT). The peer-reviewed evidence for the benefit of SLT has been uncertain. Our objective was to systematically review and meta-analytically summarize the benefit of SLT for individuals born with CLP. METHOD: A systematic search was conducted (last search on February 19, 2021) on studies evaluating SLT with pre and post measures on speech production, language ability, intelligibility, and/or patient-reported outcomes. We sought individual participant data (IPD) and evaluated on an individual level if the outcome measure had improved to a clinically relevant degree during SLT and if the outcome measure was on a level with peers or not after SLT. Meta-analyses and meta-regressions were applied to synthesize IPD across studies. RESULTS: Thirty-four eligible studies were found. Nineteen studies provided IPD (n = 343) for the main analysis on speech production. The synthesized information suggests that, during SLT, speech production improved to a clinically relevant degree for many individuals (95% CI [61%, 87%]) and that speech production was on a level with peers for some individuals after SLT (95% CI [10%, 34%]). CONCLUSIONS: The main strength of this meta-analysis is that we evaluated on an individual level pre- and post-intervention data based on considerations of clinical relevance. This approach allowed us to conclude that many individuals benefit from SLT and that further work on evaluating SLT in this patient group is meaningful. Supplemental Material https://doi.org/10.23641/asha.17700992.

Expressive vocabulary development in children with moderate hearing loss - the impact of auditory variables and early consonant production.

In this study, the early expressive vocabulary development was investigated in a group of children with moderate hearing loss (HL). Size and development of expressive vocabulary from 18 30 months were analyzed and compared to a group of children with normal hearing (NH). For the children with HL, the impact of auditory variables on number of words were examined. The relationship of early consonant production to number of words produced of both groups were examined and the phonological complexity of reported words was compared between the groups. The results showed that children with HL (n = 8) produced a similar number of words as the NH (n = 8) at 18 months, but fewer at 24 and 30 months. Hours of HA use showed significant correlations to number of words. The number of different true consonants at 18 months for the whole group showed a significant relationship to number of words produced at 24 months. No significant differences were found between children with HL and NH children regarding phonological complexity of reported words. The findings indicate that the children born with moderate HL who were fitted with hearing aids (HAs) before 6 months of age are at risk in their development of expressive vocabulary. Full-time use of HAs and monitoring of early consonant use should be encouraged in the early intervention of this target group.

Speech Outcome and Self-Reported Communicative Ability in Young Adults Born With Unilateral Cleft Lip and Palate: Comparing Long-Term Results After 2 Different Surgical Methods for Palatal Repair.

OBJECTIVE: To compare speech outcome and self-reported speech and communicative ability (SOK) in young adults treated with one-stage (OS) or two-stage (TS) palatal repair. Furthermore, to compare with normative data on individuals without cleft lip and palate and to study the relationship between patients' and experts' judgments. DESIGN: A cross-sectional group comparison study with long-term follow-up. Participants: Patients born with unilateral cleft lip and palate treated at 2 cleft centers; 17 with OS at 14 months and 25 with TS, soft palate repair at 7 months and hard palate repair at 6.2 years. Pharyngeal flap surgery was performed in 53% (OS) and 24% (TS) of patients. MAIN OUTCOME MEASURE(S): Speech characteristics were blindly assessed by speech and language pathologist from audio recordings, SOK at 19 years of age. RESULTS: No group differences were found. Although the occurrence of nasality symptoms was low in both groups, only 60% (OS)/65% (TS) were assessed with competent velopharyngeal function (VPC). Articulation proficiency (percentage of consonants correct [PCC]) was 91%/97%, the /s/-sound specifically 87%/91%. Good intelligibility was found in 91%/87%. Patient opinion was in agreement with norms and significantly associated with intelligibility (rs = 0.436, P < .01), PCC (rs = -0.534, P < .01), and correct /s/ (rs = -0.354, P < .05). CONCLUSIONS: No differences in speech outcome were related to operation method. The low prevalence of VPC was not clearly reflected in nasality symptoms. Patient opinion was related to articulation and intelligibility. A higher burden of care in terms of pharyngeal flap surgery was seen after the OS technique.

Impact of auditory variables on consonant production in babbling and early speech in children with moderate hearing loss - a longitudinal study.

This longitudinal study aimed to investigate early consonant production and the impact of hearing aid (HA) use, and aided audibility in Swedish children with moderate hearing loss (CHL) who received amplification before 6 months of age. CHL (n = 11) and children with normal hearing (CNH) (n = 11) were followed-up at 10, 18, and 36 months of age. At 10 months of age, the CHL used significantly fewer oral stops (p < 0.01), dental/alveolar stops (p < 0.05) and had a significantly fewer number of different true consonants (p < 0.01). At 18 months, there were no significant differences between the groups regarding presence of oral stops, and dental/alveolar stops, but the significant difference in the number of different true consonants remained (p < 0.00). At 36 months of age, consonant proficiency did not differ between the groups. A higher number of hours of HA use was associated with the presence of consonant variables at 10 months. Aided audibility showed weak to moderate correlations with number of consonants produced and proficiency. This group of children presented with initial delays in their early consonant production but seemed to catch up as they aged. Consistency of HA use from initial fitting is an important factor that may decrease the possible delays in the development of early consonant production and proficiency in CHL by 36 months of age.

Speech feature profiles in Swedish 5-year-olds with speech sound disorder related to suspected childhood apraxia of speech or cleft palate.

Purpose: To study the occurrence of speech features commonly associated with Childhood Apraxia of Speech (CAS) in Swedish children with suspected CAS (sCAS) or Speech Sound Disorder (SSD) related to Cleft Palate and/or Lip (CP ± L).Method: Thirty-four children (4.10-5.11) with SSD related to sCAS (n = 15) or repaired CP ± L (n = 19) participated. Consensus judgement of presence/absence of CAS features in single words were based on a checklist with operationalised definitions. Speech sound production measures were based on semi-narrow phonetic transcription. Intra- and inter-transcriber agreement was determined.Result: Twelve participants (ten with sCAS (67%) and two with CP ± L (11%)) shared a CAS profile of phonemic speech inconsistency for consonants and vowels and a set of four features: vowel error, voicing error, difficulty achieving initial articulatory configurations or transitionary movement gestures and stress errors. The most frequent speech difficulties in children with non-CAS CP ± L (n = 17) were consonant distortion (88%) and hypernasal resonance (76%). Prosodic impairment was rare.Conclusion: A distinct CAS speech feature profile was found for children with CAS, differing in number and distribution compared to children with CP ± L and SSD. CAS was found more frequently in CP ± L and SSD compared to reported estimates of clinical prevalence.

Canonical babbling ratio - Concurrent and predictive evaluation of the 0.15 criterion.

INTRODUCTION: Canonical babbling ratio (CBR) is a commonly used measure to quantify canonical babbling (CB), and 0.15 is the commonly accepted criterion for the canonical babbling stage. However, this has not been thoroughly investigated. The aim of this study was to evaluate the validity of this criterion using concurrent and predictive comparisons. METHODS: Longitudinal data from 50 children recruited in different clinical projects were used. At 10 months of age, CBR was calculated based on counted utterances from audio-video recorded parent-child interactions. The videos were also assessed by CB observation, where an observer made an overall judgement on whether the child was in the canonical babbling stage or not. For the concurrent evaluation, CBR was compared to CB observation as a reference test, using area under the curve (AUC). The criterion resulting in the best combination of sensitivity and specificity was identified using positive likelihood ratios. In the predictive comparisons CBR was analyzed as a predictor of speech/language difficulties at 30-36 months. Participants presenting with difficulties in consonant production and/or parent-reported vocabulary were considered to have speech/language difficulties. Sensitivity and specificity were compared for CBR using the 0.15 criterion and the new criterion identified in this study. RESULTS: An AUC of 0.87 indicated that CBR is a valid measure of canonical babbling in 10-month-old children. The best combination of sensitivity and specificity was found at a criterion of 0.14 (sensitivity 0.96, specificity 0.70). In the predictive comparison, CBR with a 0.14 or 0.15 criterion revealed the same sensitivity (0.71) but 0.14 showed a slightly better specificity (0.52 versus 0.42). CONCLUSIONS: CBR is a valid measure of CB (at 10 months). However, when using CBR to classify children's babbling as canonical or non-canonical, researchers need to carefully consider the implications of the chosen criterion.

Speech and Language in 5-year-olds with Different Neurological Disabilities and the Association between Early and Later Consonant Production.

The primary aim was to describe speech and language abilities in a clinical group of verbal 5-year-old children diagnosed with neurological disability (ND) in infancy, and the secondary aim was to trace precursors to consonant production at age 5 years (T2) in data from 12 to 22 months (T1). The participants (n = 11, with Down syndrome (DS), cerebral palsy, and chromosomal deletion syndromes) were tested with a battery of speech and language tests. Consonant production at T2 was compared to data on consonant use at T1. At T2, two participants had age appropriate speech and language and another three had age-appropriate speech, but low results on language tests. The remaining six participants had severe speech and language difficulties. Participants with DS had significantly lower results on consonant production measures. An association between consonant production at T1 and T2 for participants with DS indicates that number of different true consonants might be a predictive measure when evaluating young children with DS.

Treatment of active nasal fricatives substituting /s/ in young children with normal palatal function using motor-based intervention.

Purpose: The aim was to evaluate the effect of a motor-based, hierarchically structured intervention directed at active nasal fricatives substituting /s/ in young children with normal palatal function.Method: An experimental single-subject design was replicated across three children, aged 4-6 years, with normal palatal function, who substituted oral /s/ with active nasal fricatives. Treatment was performed weekly by a speech-language pathologist and included home training conducted by parents. Audio documented probes were registered regularly and /s/-production evaluated as oral or nasal.Result: All children achieved 98-100% oral production of /s/ in six probed linguistic contexts at treatment end and exhibited good maintenance at follow-up. The four-year-olds showed gradual or inconsistent response and slower progress, the six-year-old direct response and faster progress.Conclusion: The study provides preliminary evidence suggesting positive intervention effects for treating active nasal fricatives in children with normal palatal function. However, possible confounding effects such as maturation or repeated testing could not be ruled out; thus, results need to be replicated with increased experimental control. Nevertheless, the study adds to the currently meagre empirical evidence-base for the population. Individual treatment response and progress patterns were found and data suggests that the intervention may be beneficial from age 4.

Canonical Babbling and Early Consonant Development Related to Hearing in Children With Otitis Media With Effusion With or Without Cleft Palate.

OBJECTIVE: To investigate and compare babbling, early consonant production and proficiency from 10 to 36 months of age and its relationship with hearing in children with otitis media with effusion (OME) with or without cleft palate. DESIGN: Prospective, longitudinal group comparison study. SETTING: University hospital. PARTICIPANTS: Fifteen children born with nonsyndromic cleft palate with or without cleft lip (CP±L) and 15 age-matched children with hearing loss (HL) associated with OME but without cleft palate (noncleft group). MAIN OUTCOME MEASURES: Canonical babbling (CB) and early consonant variables (presence of oral stops, anterior stops, dental/alveolar stops, number of different true consonants) at 10 and 18 months, and percentage of consonants correct proficiency (PCC) at 36 months. RESULTS: A total of 54% of the CP±L group and 77% of the noncleft group had CB. The noncleft group had a significantly higher prevalence of all consonant variables. Percentage of consonants correct was 61.9% in the CP±L group and 81.6% in the noncleft group. All early consonant variables except CB were significantly related to PCC. Hearing sensitivity at 18 and 30 months correlated with PCC and explained 40% of the variation. CONCLUSIONS: Mild HL impacted presence of CB at 10 months and was related to consonant proficiency at 36 months in children with HL associated with OME and children with cleft palate. The noncleft group showed results at 36 months similar to children with normal hearing; however, the CP±L group did not. Although the cleft palate may have a bigger impact on the speech development, management of hearing sensitivity would also be beneficial.

Scandcleft Project Trial 3: Comparison of Speech Outcomes in Relation to Sequence in 2-Stage Palatal Repair Procedures in 5-Year-Olds With Unilateral Cleft Lip and Palate.

OBJECTIVE: To compare speech outcome following different sequencing of hard and soft palate closure between arms and centers within trial 3 and compare results to peers without cleft palate. DESIGN: A prospective randomized clinical trial. SETTING: Two Norwegian and 2 British centers. PARTICIPANTS: One hundred thirty-six 5-year-olds with unilateral cleft lip and palate were randomized to either lip and soft palate closure at 3 to 4 months and hard palate closure at 12 months (arm A) or lip and hard palate closure at 3 to 4 months and soft palate closure at 12 months (arm D). MAIN OUTCOME MEASURES: A composite measure of velopharyngeal competence (VPC), overall assessment of VPC from connected speech (VPC-Rate). Percentage of consonants correct (PCC), active cleft speech characteristics (CSCs), subdivided by oral retracted and nonoral errors, and developmental speech characteristics (DSCs). RESULTS: Across the trial, 47% had VPC, with no statistically significant difference between arms within or across centers. Thirty-eight percent achieved a PCC score of >90%, with no difference between arms or centers. In one center, significantly more children in arm A produced ≥3 active CSCs (P < .05). Across centers, there was a statistically significant difference in active CSCs (arm D), oral retracted CSCs (arm D), and DSCs (arms A and D). CONCLUSIONS: Less than half of the 5-year-olds achieved VPC and around one-third achieved age-appropriate PCC scores. Cleft speech characteristics were more common in arm A, but outcomes varied within and across centers. Thus, outcome of the same surgical method can vary substantially across centers.

Assessment of prelinguistic vocalizations in real time: a comparison with phonetic transcription and assessment of inter-coder-reliability.

This study investigated reliability of naturalistic listening in real time (NLRT) compared to phonetic transcription. Speech pathology students with brief training in NLRT assessed prelinguistic syllable inventory size and specific syllable types in typically developing infants. A second study also examined inter-coder reliability for canonical babbling, canonical babbling ratio and presence of oral stops in syllable inventory of infants with cleft palate, by means of NLRT. In study 1, ten students independently assessed prelinguistic samples of five 12-month-old typically developing infants using NLRT and phonetic transcription. Coders assessed syllable inventory size as more than twice as large using phonetic transcription as NLRT. Results showed a strong correlation between NLRT and phonetic transcription (syllables with more than five occurrences) for syllable inventory size (r = .60; p < .001). The methods showed similar results for inter-coder reliability of specific syllable types. In study 2, three other students assessed prelinguistic samples of twenty-eight 12-month-old infants with cleft palate by means of NLRT. Results revealed perfect inter-coder agreement for presence/absence of canonical babbling, strong correlations between the three coders' assessment of syllable inventory size (average r = .83; p < .001), but more inter-coder variability for agreement of specific syllable types. In conclusion, NLRT is a reliable method for assessing prelinguistic measures in infants with and without cleft palate with inter-coder agreement levels comparable to phonetic transcription for specific syllable types.

Towards an Integrated Curriculum in a Speech and Language Pathology Education Programme: Development and Constituents' Initial Responses.

BACKGROUND: A traditional curricular structure may challenge integration between foundational and clinical sciences in speech and language pathology (SLP) education. This project aimed to increase curriculum integration at a Swedish SLP education programme. METHODS: Learning outcomes in the existent curriculum were copied from their original courses and re-structured with reference to vertical tracks, in order to address them within and across years of study. A content analysis of interviews with teachers and students was conducted for the evaluation of curricular change. RESULTS: Among the changes were earlier introduction to clinical science and revisiting of foundational sciences later in the education. Theme concepts were defined to scaffold horizontal integration, whereas revisited use of documented material was formalized to ensure vertical integration. In evaluation interviews, multiple examples were provided of how the new curriculum was perceived as being more integrated, with horizontal themes and vertical tracks providing structure. Concerns raised highlight the importance of appointing clear responsibilities. CONCLUSIONS: The concepts "gaps" and "overlaps" may guide remediation of areas where increased curricular integration is warranted. Serial child observations running through the curriculum may provide a platform for both horizontal and vertical integration. For maintenance of curricular integration, clear responsibilities are needed, stretching across course and semester boundaries.

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.

Babbling and consonant production in children with hearing impairment who use hearing aids or cochlear implants - a pilot study.

Objective: To investigate early auditory prerequisites in relation to the use of canonical babbling (CB) and early consonant production in a heterogeneous group of children with hearing impairment (HI) and in comparison to controls with normal hearing (NH).Methods: Five children with unilateral or bilateral HI who used hearing aids (HA) (0;9-1;7 years) and six children with cochlear implants (CI) (0;10-2;0 years) were compared to data from 22 children with NH (0;10-1;6 years). Hearing age, type of HI and daily use of hearing technology (hours) was investigated in relation to CB ratio and consonant production. Analysis of babbling from video recordings during verbal interaction between a parent and child was independently performed by two observers. Intra- and inter-agreement were calculated.Results: Children with HI used less CB compared to children with NH. Less CB utterances and occurrences of dental/alveolar stops were found in children with HA who had a hearing age of 5 months and who used their hearing technology 5 h per day. The children with CI reached an expected CB ratio and consonant production after 8.5 months with daily fulltime use of CI.Conclusions: Even a mild hearing loss in early childhood may affect and delay the onset of important linguistic milestones like canonical babbling and consonant production. It was indicated that children with CI or HA might receive different attention and intervention services. Longer hearing age and full-time use of hearing technology may influence positively on CB ratio and consonant production in children with HI.

Hearing Thresholds in Young Children With Otitis Media With Effusion With and Without Cleft Palate.

OBJECTIVE: To investigate hearing thresholds in children born with cleft palate and in children with otitis media with effusion but no cleft palate. DESIGN: Prospective longitudinal group comparison study. SETTING: University hospital. PARTICIPANTS: Sixteen children born with nonsyndromic cleft palate with or without cleft lip (CP±L) and 15 age-matched children with otitis media with effusion (OME) but without cleft. MAIN OUTCOME MEASURES: Hearing was tested at repeated occasions beginning with neonatal auditory brainstem response (ABR) at 1-4 months of age, and age-appropriate hearing tests from 9 to 36 months of age. RESULTS: The median ABR thresholds in both groups were elevated but did not differ significantly. At 12 months of age, the median 4 frequency averages at 500-1000-2000-4000 Hz (4FA) were indicative of mild hearing loss but significantly better in the CP±L-group than in the group without cleft (P < .01). There were no significant group-wise differences regarding the median 4FA at 24 and 36 months of age, and at 36 months, the median 4FA were normal in both groups. Both groups exhibited a significant improvement over time from the neonatal ABR thresholds to the 4FA at 36 months (CP±L-group P < .05; without CP±L-group P < .01). CONCLUSION: The hearing loss in children with CP±L was not more severe than among children with OME but without cleft palate; rather, at 12 months of age, the thresholds were significantly better in the CP±L-group than those in the group without cleft. The air conduction thresholds improved with age in both groups.

Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age.

INTRODUCTION: Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes. METHODS AND ANALYSIS: Infants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan. ETHICS AND DISSEMINATION: Ethical approval has been sought in each participating country according to country-specific procedures. Trial results will be presented at conferences, published in peer-reviewed journals and disseminated through relevant patient support groups. TRIAL REGISTRATION NUMBER: NCT00993551; Pre-results.