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Background Children with Down Syndrome (DS) are more likely to have multi-system comorbidities leading to more frequent hospitalizations than the general population. We aim to evaluate whether racial differences contribute to hospitalization outcomes and mortality among children with DS. Methods Hospital discharge records were obtained for children (< 21 y) with DS hospitalized between 2006 and 2019 from the Kid’s Inpatient Database. The primary exposure was the Black race. Primary outcomes were invasive mechanical ventilation (IMV) and mortality. Secondary outcomes were non-invasive mechanical ventilation (NIMV), length of hospital stay (LOS), and inflation-adjusted cost of hospitalization (IACH). Multivariable logistic regression models were used to ascertain associations between Black race and outcomes. Results Among 163,870 hospitalizations in children with DS, 16,208 (9.89%) were Black children. Compared with non-Black children, Black children were younger, of lower household incomes, more likely to have public insurance, more likely to have asthma, OSA, obesity, prematurity, congenital heart disease, pulmonary hypertension, congenital airway anomalies, neuromuscular weakness, and dysphagia. Descriptive analyses indicated that Black race was associated with higher risks of mortality, IMV, NIMV, longer LOS, and greater IACH. After multivariable adjustment, Black race remained independently associated with mortality (OR:1.35, 95%-CI:1.15–1.59, p  < 0.0001), IMV (OR:1.34, 95%-CI:1.23–1.45, p  < 0.0001), NIMV (OR:1.41, 95%-CI:1.26–1.59, p  < 0.0001) and increased LOS (IRR:1.08, 95%-CI:1.04–1.13, p  < 0.0001), but not IACH. Conclusions Hospitalized Black children with DS are more likely to be younger, of lower household incomes, with public insurance, and with other underlying comorbidities. Black children had increased risks of mortality and IMV and increased LOS.

Abstract Study Objectives Obstructive sleep apnea is associated with neurobehavioral dysfunction, but the relationship between disease severity as measured by the apnea-hypopnea index and neurobehavioral morbidity is unclear. The objective of our study is to compare the neurobehavioral morbidity of mild sleep-disordered breathing versus obstructive sleep apnea. Methods Children 3–12 years old recruited for mild sleep-disordered breathing (snoring with obstructive apnea-hypopnea index < 3) into the Pediatric Adenotonsillectomy Trial for Snoring were compared to children 5–9 years old recruited for obstructive sleep apnea (obstructive apnea-hypopnea 2–30) into the Childhood Adenotonsillectomy Trial. Baseline demographic, polysomnographic, and neurobehavioral outcomes were compared using univariable and multivariable analysis. Results The sample included 453 participants with obstructive sleep apnea (median obstructive apnea-hypopnea index 5.7) and 459 participants with mild sleep-disordered breathing (median obstructive apnea-hypopnea index 0.5). By polysomnography, participants with obstructive sleep apnea had poorer sleep efficiency and more arousals. Children with mild sleep-disordered breathing had more abnormal executive function scores (adjusted odds ratio 1.96, 95% CI 1.30–2.94) compared to children with obstructive sleep apnea. There were also elevated Conners scores for inattention (adjusted odds ratio 3.16, CI 1.98–5.02) and hyperactivity (adjusted odds ratio 2.82, CI 1.83–4.34) in children recruited for mild sleep-disordered breathing. Conclusions Abnormal executive function, inattention, and hyperactivity were more common in symptomatic children recruited into a trial for mild sleep-disordered breathing compared to children recruited into a trial for obstructive sleep apnea. Young, snoring children with only minimally elevated apnea-hypopnea levels may still be at risk for deficits in executive function and attention. Trial Registration Pediatric Adenotonsillectomy for Snoring (PATS), NCT02562040; Childhood Adenotonsillectomy Trial (CHAT), NCT00560859

Structural risk factors for obstructive sleep apnea syndrome (OSAS) in adolescents have not been well characterized. Because many adolescents with OSAS are obese, we hypothesized that the anatomic OSAS risk factors would be more similar to those in adults than those in children. To investigate the anatomic risk factors in adolescents with OSAS compared with obese and lean control subjects using magnetic resonance imaging (MRI). Three groups of adolescents (age range: 12-16 yr) underwent MRI: obese individuals with OSAS (n = 49), obese control subjects (n = 38), and lean control subjects (n = 50). We studied 137 subjects and found that (1) obese adolescents with OSAS had increased adenotonsillar tissue compared with obese and lean control subjects; (2) obese OSAS adolescents had a smaller nasopharyngeal airway than control subjects; (3) the size of other upper airway soft tissue structures (volume of the tongue, parapharyngeal fat pads, lateral walls, and soft palate) was similar between subjects with OSAS and obese control subjects; (4) although there were no major craniofacial abnormalities in most of the adolescents with OSAS, the ratio of soft tissue to craniofacial space surrounding the airway was increased; and (5) there were sex differences in the pattern of lymphoid proliferation. Increased size of the pharyngeal lymphoid tissue, rather than enlargement of the upper airway soft tissue structures, is the primary anatomic risk factor for OSAS in obese adolescents. These results are important for clinical decision making and suggest that adenotonsillectomy should be considered as the initial treatment for OSAS in obese adolescents, a group that has poor continuous positive airway pressure adherence and difficulty in achieving weight loss.

IntroductionObstructive sleep apnoea (OSA) affects 1–5% of the paediatric population, including 55–90% of children with Down syndrome (DS), and has been associated with negative effects on neurocognitive development, cardiovascular health, immune development and quality of life. In-lab attended polysomnography (PSG) is currently the gold standard for the diagnosis of OSA in children, but it poses challenges due to the burden on families and limited testing facilities. Home sleep apnoea testing (HSAT), an unattended sleep test done at home, is an accepted alternative for adults but lacks sufficient evidence to be used clinically for the evaluation of OSA in children. HSAT may be especially beneficial for children with DS or others with sensory issues or those who struggle with sleeping in a laboratory setting overnight.Methods and analysisThis single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS. The trial will enrol 317 children 5–12 years old, including approximately 100 with DS. The primary outcome is the diagnostic accuracy of HSAT compared with PSG for OSA evaluated through ROC. Secondary outcomes include the agreement between HSAT and PSG for therapeutic decision-making and comparison of preference and acceptability of HSAT versus PSG. This trial seeks to evaluate HSAT as an alternative diagnostic tool for paediatric OSA, potentially expanding testing options for clinicians and families.Ethics and disseminationThis study has been approved by the Institutional Review Board at Children’s Hospital of Philadelphia (#21–0 19 533). Informed consent will be obtained from all participants, and no identifiable data will be reported.Trial registration numberNCT05382754.

IntroductionIndividuals with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA) due to craniofacial features (eg, midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSA in this population is markedly increased compared with that of typically developing children. Adenotonsillectomy is considered the first-line treatment for childhood OSA. However, persistent OSA is common, thus many children with DS are referred for positive airway pressure (PAP) therapy initiation; PAP appears to be an important aspect of living with DS. PAP has been shown to be highly effective in the general population for treating OSA and improving OSA-associated neurobehavioural symptoms, such as quality of life, behaviour, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSA has not been well-studied in children with DS. Therefore, we designed a multicentre randomised controlled trial recruiting children with DS and OSA at three academic institutions, aged 6–18 years, referred for PAP initiation to treat OSA.Methods and analysis86 participants will be randomised to a 6-month intensive behavioural intervention (INT) to improve PAP adherence versus standard clinical care and underwent standardised evaluations of quality of life, behaviour, attention, PAP adherence and healthcare utilisation at baseline, 6 months and 12 months.Ethics and disseminationThis study has been approved by the institutional review board at Children’s Hospital of Philadelphia (IRB of record, IRB # 20–0 17 512). Cincinnati Children’s Medical Center and University of Miami delegated IRB review and approval responsibility to Children’s Hospital of Philadelphia through reliance agreements as mandated by National Institutes of Health (NIH). All participants will be minors; consent will be obtained from parents and assent from participants will be obtained when possible. The intervention tested in this trial is considered not greater than minimal risk, and no identifiable data will be reported. As required by the NIH, a data safety monitoring board (DSMB) has been formed, who will review and approve the protocol and any protocol changes prior to implementation. The study team will send biannual reports and hold a biannual meeting with the DSMB to review any safety and protocol concerns. Findings will be presented at national conferences pertinent to this topic and published in peer-reviewed medical journals. In addition, findings will be shared in the lay format with DS associations around the world and used for training of healthcare providers and trainees (R25HD118212). Further, data collected will be deposited in a repository (National Sleep Research Resource; sleepdata.org) after completion of the study to maximise use by scientific community.Trial registration numberNCT04132999.

The recent National Institute of Health (NIH) INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) initiative has bolstered capacity for the current increase in clinical trials involving individuals with Down syndrome (DS). This new NIH funding mechanism offers new opportunities to expand and develop novel approaches in engaging and effectively enrolling a broader representation of clinical trials participants addressing current medical issues faced by individuals with DS. To address this opportunity, the NIH assembled leading clinicians, scientists, and representatives of advocacy groups to review existing methods and to identify those areas where new approaches are needed to engage and prepare DS populations for participation in clinical trial research. This paper summarizes the results of the Clinical Trial Readiness Working Group that was part of the INCLUDE Project Workshop: Planning a Virtual Down Syndrome Cohort Across the Lifespan Workshop held virtually September 23 and 24, 2019.

IntroductionSleep deficiencies, such as sleep disordered breathing (SDB) and insufficient sleep, are linked to adverse health outcomes. These sleep deficiencies are more common in racial and ethnic minoritised children and have significant negative impacts on neurobehavioural and social-emotional development. Non-Latine Black/African American children are 4–6 times more likely than non-Latine White children to experience both SDB and short sleep duration. Although SDB and insufficient sleep often co-occur in young children, there is a paucity of research considering the potential unique and additive impacts of SDB and insufficient sleep on child outcomes, as well as racial disparities in these outcomes, thus hindering comprehensive interventions. Our study objectives are to (1) examine racial disparities in the neurobehavioural and social-emotional impacts of early childhood SDB and/or insufficient sleep and (2) identify proximal and distal socioecological factors linked to these sleep disparities and outcomes.Methods and analysisA cross-sectional observational study comparing neurobehavioural (executive functioning, attention, vigilance) and social-emotional functioning (social skills, emotion regulation) in 400 dyads consisting of caregivers and their otherwise healthy Black and White 3–5 year-old children and divided into four groups: (A) preschoolers with SDB; (B) preschoolers with insufficient sleep; (C) preschoolers with both SDB and insufficient sleep and (D) matched controls. Child SDB, insufficient sleep, neurobehavioural skills and social-emotional functioning are measured using validated objective and subjective assessment tools, with a subset of caregivers completing qualitative interviews. Primary outcomes include individual differences in neurobehavioural and social-emotional functioning in these groups of Black and White preschoolers, and multilevel socioecological factors associated with variation in outcomes. Quantitative data will be analysed using descriptive analyses, linear regression and comparison of model coefficients. Qualitative data will be coded using thematic analysis and a joint display to stratify qualitative themes by child race and sleep deficiencies.Ethics and disseminationThe study protocol has been approved by the institutional review board of the Children’s Hospital of Philadelphia and the University of Oregon. Results will be disseminated through peer-reviewed publications and conferences.

IntroductionMild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.Methods and analysisThe Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.Ethics and disseminationThe study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.Trial registration numberNCT02562040; Pre-results.

Climate change and wildfire smoke significantly compromise sleep health, particularly in healthcare environments where vulnerable populations such as children face heightened risk. This study proposes wildfire-resilient, sleep health-driven mechanical ventilation control strategies for children's hospitals aimed at mitigating the adverse effects of wildfire smoke on sleep health. A sleep health model linking sleep environment factors to the probability of severe obstructive sleep apnea (OSA) was developed and integrated into a hospital's ventilation control system. Our proposed strategy employs dynamic PM2.5 thresholds to adaptively control the outdoor air changes per hour, optimizing both children's sleep health outcomes and energy efficiency. Through EnergyPlus simulations, our strategy outperformed traditional ventilation methods, reducing the probability of severe OSA by 5.3% to 21.6% and simultaneously achieving notable energy savings. The incorporation of advanced filtration systems, such as MERV 16 and HEPA, was particularly effective in maintaining indoor air quality (IAQ) and sleep health during high pollution episodes. Our findings emphasize the value of incorporating sleep health considerations into mechanical ventilation designs in children's hospitals. Our results indicate that ventilation strategies integrated with a sleep health model and enhanced filtration can improve sleep health and energy efficiency, offering a robust response to wildfire smoke challenges in healthcare environments.

Abstract Study Objectives Increased neck circumference, a surrogate for the neck fat that can narrow the upper airway in obese individuals, is a risk factor for obstructive sleep apnea syndrome (OSAS) in adults, but the association between neck fat and OSAS in adolescent males and females is unknown. We hypothesized that obese adolescents with OSAS have more neck fat than controls, females more neck fat than males, and that neck fat correlates with obesity and OSAS severity. Methods Obese adolescents with OSAS and obese and normal-weight controls underwent upper airway magnetic resonance imaging, polysomnography, and anthropometrics, including neck circumference measurement. Intra-neck and subcutaneous neck fat measurements were manually segmented and compared among the three groups using ANOVA and between males and females using t-tests. The relationship between polysomnographic parameters and neck fat measurements was assessed in adolescents with OSAS using Pearson correlations. Results One-hundred nineteen adolescents (38 females) were studied: 39 obese with OSAS, 34 obese controls, and 46 normal-weight controls. Neck fat was not greater in adolescents with OSAS compared to obese controls (p=0.35), and neck fat volume was not related to OSAS severity (p = 0.36). However, obese adolescents had more neck fat than normal-weight controls (p < 0.001), and neck fat volume correlated with neck circumference (r = 0.53, p < 0.001). Females had significantly greater cross-sectional neck fat than males (p < 0.001). Conclusions While neck fat is associated with obesity and neck circumference in adolescents and is greater in females versus males, it does not appear to correlate with presence and severity of OSAS.