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1.
BMJ Open ; 14(7): e078994, 2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39089712

RESUMEN

OBJECTIVES: To explore the experiences and perceptions of children with bronchiectasis and their parents regarding an 8-week play-based therapeutic exercise programme. DESIGN: Qualitative study with inductive content analysis. SETTING: Individual semistructured interviews were conducted. Interview recordings were transcribed verbatim, and coding was guided by the content. Content categories were established via consensus moderation. PARTICIPANTS: 10 parents and 10 children with bronchiectasis aged 5-12 years. RESULTS: From the perspective of children, the most important components of the programme were fun with friends and being active at home as a family. Parents valued the community-based sessions, perceived the programme to be engaging and motivating. Parents perceived improvements in their child's endurance, coordination and physical activity level. They described the home programme as fun but noted that finding time was difficult. Both parents and children thought that in-person exercise sessions would be better than exercise sessions delivered online. CONCLUSIONS: Children who participated in the play-based exercise programme, found it fun, motivating and accessible. Parents perceived positive impacts on fitness, coordination and physical activity. TRIAL REGISTRATION NUMBER: The trial was registered with, Australian and New Zealand Clinical Trials Register (ACTRN12619001008112).


Asunto(s)
Bronquiectasia , Terapia por Ejercicio , Padres , Investigación Cualitativa , Humanos , Bronquiectasia/terapia , Bronquiectasia/psicología , Padres/psicología , Niño , Masculino , Femenino , Terapia por Ejercicio/métodos , Preescolar , Motivación , Juego e Implementos de Juego , Entrevistas como Asunto , Nueva Zelanda , Ejercicio Físico/psicología , Australia , Adulto
2.
BMJ Open ; 14(8): e090749, 2024 Aug 21.
Artículo en Inglés | MEDLINE | ID: mdl-39174059

RESUMEN

INTRODUCTION: A minority of school-aged children with asthma have persistent poor control and experience frequent asthma attacks despite maximal prescribed maintenance therapy. These children have higher morbidity and risk of death. The first add-on biologic therapy, omalizumab, a monoclonal antibody that blocks immunoglobulin (Ig)E, was licensed for children with severe asthma in 2005. While omalizumab is an effective treatment, non-response is common. A second biologic, mepolizumab which blocks interleukin 5 and targets eosinophilic inflammation, was licensed in 2018, but the licence was granted by extrapolation of adult clinical trial data to children. This non-inferiority (NI) trial will determine whether mepolizumab is as efficacious as omalizumab in reducing asthma attacks in children with severe therapy resistant asthma (STRA) and refractory difficult asthma (DA). METHODS AND ANALYSIS: This is an ongoing multicentre 1:1 randomised NI open-label trial of mepolizumab and omalizumab. Up to 150 children and young people (CYP) aged 6-17 years with severe asthma will be recruited from specialist paediatric severe asthma centres in the UK. Prior to randomisation, children will be monitored for medication adherence for up to 16 weeks to determine STRA and refractory DA diagnoses. Current prescribing recommendations of serum IgE and blood eosinophils will not influence eligibility or enrolment. The primary outcome is the 52-week asthma attack rate. Bayesian analysis using clinician-elicited prior distributions will be used to calculate the posterior probability that mepolizumab is not inferior to omalizumab. Secondary outcomes include Composite Asthma Severity Index, Paediatric Asthma Quality of Life Questionnaire, lung function measures (forced expiratory volume in one second (FEV1), bronchodilator reversibility), fractional exhaled nitric oxide, Asthma Control Test (ACT), health outcomes EuroQol 5 Dimension (EQ-5D) and optimal serum IgE and blood eosinophil levels that may predict a response to therapy. These outcomes will be analysed in a frequentist framework using longitudinal models. ETHICS AND DISSEMINATION: The study has been approved by the South Central-Berkshire Research Ethics Committee REC Number 19/SC/0634 and had Clinical Trials Authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) (EudraCT 2019-004085-17). All parents/legal guardians will give informed consent for their child to participate in the trial, and CYP will give assent to participate. The results will be published in peer-reviewed journals, presented at international conferences and disseminated via our patient and public involvement partners. TRIAL REGISTRATION NUMBER: ISRCTN12109108; EudraCT Number: 2019-004085-17.


Asunto(s)
Antiasmáticos , Anticuerpos Monoclonales Humanizados , Asma , Omalizumab , Humanos , Asma/tratamiento farmacológico , Niño , Omalizumab/uso terapéutico , Antiasmáticos/uso terapéutico , Adolescente , Anticuerpos Monoclonales Humanizados/uso terapéutico , Calidad de Vida , Masculino , Femenino , Estudios de Equivalencia como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Índice de Severidad de la Enfermedad
3.
BMJ Open ; 14(3): e075733, 2024 Mar 08.
Artículo en Inglés | MEDLINE | ID: mdl-38458782

RESUMEN

AIMS: The aim was to evaluate whether standardised exercise performance during the incremental shuttle walk test (ISWT) can be used to assess disease severity in children and young people (CYP) with chronic conditions, through (1) identifying the most appropriate paediatric normative reference equation for the ISWT, (2) assessing how well CYP with haemophilia and cystic fibrosis (CF) perform against the values predicted by the best fit reference equation and (3) evaluating the association between standardised ISWT performance and disease severity. METHODS: A cross-sectional analysis was carried out using existing data from two independent studies (2018-2019) at paediatric hospitals in London,UK. CYP with haemophilia (n=35) and CF (n=134) aged 5-18 years were included. Published reference equations for standardising ISWT were evaluated through a comparison of populations, and Bland-Altman analysis was used to assess the level of agreement between distances predicted by each equation. Associations between ISWT and disease severity were assessed with linear regression. RESULTS: Three relevant reference equations were identified for the ISWT that standardised performance based on age, sex and body mass index (Vardhan, Lanza, Pinho). A systematic proportional bias of standardised ISWT was observed in all equations, most pronounced with Vardhan and Lanza; the male Pinho equation was identified as most appropriate. On average, CYP with CF and haemophilia performed worse than predicted by the Pihno equation, although the range was wide. Standardised ISWT, and not ISWT distance alone, was significantly associated with forced expiratory volume in 1 s in CYP with CF. Standardised ISWT in CYP with haemophilia was slightly associated with haemophilia joint health score, but this was not significant. CONCLUSIONS: ISWT performance may be useful in a clinic to identify those with worsening disease, but only when performance is standardised against a healthy reference population. The development of validated global reference equations is necessary for more robust assessment.


Asunto(s)
Fibrosis Quística , Hemofilia A , Humanos , Masculino , Niño , Adolescente , Prueba de Paso , Estudios Transversales , Tolerancia al Ejercicio , Enfermedad Crónica , Gravedad del Paciente , Prueba de Esfuerzo , Caminata
4.
BMJ Open ; 14(2): e076730, 2024 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-38365293

RESUMEN

INTRODUCTION: The most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is a multidisciplinary research team who have conducted research on the risk factors associated with CP respiratory disease, a systematic review on management and a Delphi study on the development of a consensus for the prevention and management of respiratory disease in CP. These strategies have not been investigated; therefore, it is not known if implementation is feasible, if they improve patient outcomes or if they are acceptable for families. METHODS AND ANALYSIS: Mixed-method feasibility pilot randomised controlled trial with economic analysis. Twenty children with CP aged 0-12 years who are at risk of respiratory disease will be followed up for 1 year. All children will receive baseline assessments for comparison. The control group will receive usual care from their treating teams. The intervention group will receive comprehensive assessments from physiotherapy, speech pathology and respiratory medicine. An individualised investigation and treatment plan will then be made. Participants in both groups will complete fortnightly patient-reported outcome surveys to assess symptoms and health service use. Analysis will include assessments of acceptability through qualitative interviews, implementation by ability to recruit, randomise and retain, practicality including costs of intervention and hospitalisation, and explore efficacy through quality-of-life surveys and decreased health service use for respiratory-related symptoms. ETHICS AND DISSEMINATION: Ethics and governance approvals have been obtained through Child and Adolescent Health Service Human Research Ethics Committee. At completion, this study will lead to the design of the definitive protocol to test intervention efficacy that maximises recruitment, retention and adherence to interventions. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620000114943).


Asunto(s)
Parálisis Cerebral , Estudios de Factibilidad , Humanos , Parálisis Cerebral/terapia , Proyectos Piloto , Preescolar , Niño , Lactante , Ensayos Clínicos Controlados Aleatorios como Asunto , Hospitalización , Masculino , Femenino , Recién Nacido , Enfermedades Respiratorias/terapia , Australia
5.
BMJ Open ; 14(2): e080298, 2024 Feb 19.
Artículo en Inglés | MEDLINE | ID: mdl-38373859

RESUMEN

INTRODUCTION: Inhaled nitric oxide (iNO) use is recommended for persistent pulmonary hypertension of the newborn in term and late preterm infants. Recently, iNO therapy to prevent bronchopulmonary dysplasia (BPD) or rescue for hypoxic respiratory failure and pulmonary hypertension secondary to BPD has increasingly been used in preterm infants after 7 days of postnatal age (in the postacute phase), despite its off-label use. However, the initiation criteria of iNO therapy for preterm infants in the postacute phase are varied. The aim of this scoping review is to identify the clinical and/or echo findings at the initiation of iNO therapy in preterm infants in the postacute phase. METHODS AND ANALYSIS: We will search PubMed, Embase and the Japanese database 'Ichushi.' The following studies will be included in the review: randomised controlled trials, prospective/retrospective cohort studies, case-control studies and case series on iNO therapy for preterm infants in the postacute phase; studies published between January 2003 and August 2023; studies conducted in developed countries and studies written in English or Japanese. We will independently screen, extract and chart data using the population-concept-context framework following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We will summarise the characteristics and findings of the included studies. ETHICS AND DISSEMINATION: Obtaining an institutional review board approval is not required because of the nature of this review. A final report of review findings will be published and disseminated through a peer-reviewed journal and presentation at relevant conferences. TRIAL REGISTRATION NUMBER: UMIN000051498.


Asunto(s)
Displasia Broncopulmonar , Recien Nacido Prematuro , Óxido Nítrico , Humanos , Óxido Nítrico/administración & dosificación , Óxido Nítrico/uso terapéutico , Administración por Inhalación , Recién Nacido , Displasia Broncopulmonar/tratamiento farmacológico , Displasia Broncopulmonar/prevención & control , Proyectos de Investigación , Hipertensión Pulmonar/tratamiento farmacológico
6.
BMJ Open ; 13(8): e074147, 2023 08 17.
Artículo en Inglés | MEDLINE | ID: mdl-37591653

RESUMEN

OBJECTIVE: To understand caregiver, healthcare professional and national expert perspectives on implementation of a just-in-time adaptive intervention, RE-PACT (Respiratory Exacerbation-Plans for Action and Care Transitions) to prevent respiratory crises in severe cerebral palsy. DESIGN: Qualitative research study. SETTING: Paediatric complex care programmes at two academic medical institutions. PARTICIPANTS: A total of n=4 focus groups were conducted with caregivers of children with severe cerebral palsy and chronic respiratory illness, n=4 with healthcare professionals, and n=1 with national experts. METHODS: Participants viewed a video summarising RE-PACT, which includes action planning, mobile health surveillance of parent confidence to avoid hospitalisation and rapid clinical response at times of low confidence. Moderated discussion elicited challenges and benefits of RE-PACT's design, and inductive thematic analysis elicited implementation barriers and facilitators. RESULTS: Of the 19 caregivers recruited, nearly half reported at least one hospitalisation for their child in the prior year. Healthcare professionals and national experts (n=26) included physicians, nurses, respiratory therapists, social workers and researchers. Four overarching themes and their barriers/facilitators emphasised the importance of design and interpersonal relationships balanced against health system infrastructure constraints. Intervention usefulness in crisis scenarios relies on designing action plans for intuitiveness and accuracy, and mobile health surveillance tools for integration into daily life. Trust, knowledge, empathy and adequate clinician capacity are essential components of clinical responder-caregiver relationships. CONCLUSIONS: RE-PACT's identified barriers are addressable. Just-in-time adaptive interventions for cerebral palsy appear well-suited to address families' need to tailor intervention content to levels of experience, preference and competing demands.


Asunto(s)
Parálisis Cerebral , Niño , Humanos , Parálisis Cerebral/terapia , Investigación Cualitativa , Personal de Salud , Grupos Focales , Técnicos Medios en Salud
7.
BMJ Open ; 13(7): e070761, 2023 07 30.
Artículo en Inglés | MEDLINE | ID: mdl-37518086

RESUMEN

OBJECTIVES: The objectives of this systematic review are to identify studies that assess the effectiveness of patient-directed financial incentive interventions to improve asthma management behaviours, determine overall effectiveness of financial incentives, identify design characteristics of effective interventions and assess the impact on longer-term outcomes in the context of asthma. DESIGN: Systematic review with narrative synthesis. DATA SOURCES: Electronic databases (MEDLINE, Embase, Global Health, PsycINFO, CINAHL, PubMed and Web of Science) and grey literature sources (NHS Digital, CORE, ProQuest, Clinical Trials Register and EU Clinical Trials Register) were searched in November 2021 and updated March 2023. ELIGIBLITY CRITERIA: Eligible articles assessed financial incentives to improve asthma management behaviours (attendance at appointments, medication adherence, tobacco smoke/allergen exposure, inhaler technique and asthma education) for patients with asthma or parents/guardians of children with asthma. Eligible study design included randomised controlled, controlled or quasi-randomised trials and retrospective/prospective cohort, case-controlled or pilot/feasibility studies. SYNTHESIS: A narrative synthesis was conducted; eligible studies were grouped by asthma management behaviours and financial incentive framework domains. RESULTS: We identified 4268 articles; 8 met the inclusion criteria. The studies were from the USA (n=7) and the UK (n=1). Asthma management behaviours included attendance at appointments (n=4), reduction in smoke exposure (n=1) and medication adherence (n=3). Five studies demonstrated positive behaviour change, four of which were significant (attendance at appointments (n=3) showed significant differences between intervention and control: 73% and 49% in one study, 46.3% and 28.9% in another, and 35.7% and 18.9%, respectively; medication adherence (n=1) showed significant change from 80% during intervention to 33% post intervention). These four significant studies used 'positive gain', 'certain', 'fixed' financial incentives of smaller magnitude, given for 'all' instances of behaviour. CONCLUSION: There is some evidence that patient-directed financial incentives improve asthma management behaviours. However, in view of the wide heterogeneity in study design and measured outcomes, determining overall effectiveness was challenging. PROSPERO REGISTRATION NUMBER: CRD42021266679.


Asunto(s)
Asma , Motivación , Niño , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Asma/tratamiento farmacológico , Cumplimiento de la Medicación
8.
BMJ Open ; 12(10): e064288, 2022 10 21.
Artículo en Inglés | MEDLINE | ID: mdl-36270755

RESUMEN

PURPOSE: Exposures early in life, beginning in utero, have long-term impacts on mental and physical health. The ECHO prenatal and early childhood pathways to health consortium (ECHO-PATHWAYS) was established to examine the independent and combined impact of pregnancy and childhood chemical exposures and psychosocial stressors on child neurodevelopment and airway health, as well as the placental mechanisms underlying these associations. PARTICIPANTS: The ECHO-PATHWAYS consortium harmonises extant data from 2684 mother-child dyads in three pregnancy cohort studies (CANDLE [Conditions Affecting Neurocognitive Development and Learning in Early Childhood], TIDES [The Infant Development and Environment Study] and GAPPS [Global Alliance to Prevent Prematurity and Stillbirth]) and collects prospective data under a unified protocol. Study participants are socioeconomically diverse and include a large proportion of Black families (38% Black and 51% White), often under-represented in research. Children are currently 5-15 years old. New data collection includes multimodal assessments of primary outcomes (airway health and neurodevelopment) and exposures (air pollution, phthalates and psychosocial stress) as well as rich covariate characterisation. ECHO-PATHWAYS is compiling extant and new biospecimens in a central biorepository and generating the largest placental transcriptomics data set to date (N=1083). FINDINGS TO DATE: Early analyses demonstrate adverse associations of prenatal exposure to air pollution, phthalates and maternal stress with early childhood airway outcomes and neurodevelopment. Placental transcriptomics work suggests that phthalate exposure alters placental gene expression, pointing to mechanistic pathways for the developmental toxicity of phthalates. We also observe associations between prenatal maternal stress and placental corticotropin releasing hormone, a marker of hormonal activation during pregnancy relevant for child health. Other publications describe novel methods for examining exposure mixtures and the development of a national spatiotemporal model of ambient outdoor air pollution. FUTURE PLANS: The first wave of data from the unified protocol (child age 8-9) is nearly complete. Future work will leverage these data to examine the combined impact of early life social and chemical exposures on middle childhood health outcomes and underlying placental mechanisms.


Asunto(s)
Exposición a Riesgos Ambientales , Efectos Tardíos de la Exposición Prenatal , Adolescente , Niño , Preescolar , Femenino , Humanos , Embarazo , Estudios de Cohortes , Hormona Liberadora de Corticotropina , Exposición a Riesgos Ambientales/efectos adversos , Placenta , Estudios Prospectivos
9.
BMJ Open ; 12(7): e060986, 2022 07 08.
Artículo en Inglés | MEDLINE | ID: mdl-35803625

RESUMEN

INTRODUCTION: Supplemental oxygen is the most important treatment for preterm born infants with established bronchopulmonary dysplasia (BPD). However, it is unknown what oxygen saturation levels are optimal to improve outcomes in infants with established BPD from 36 weeks postmenstrual age (PMA) onwards. The aim of this study is to compare the use of a higher oxygen saturation limit (≥95%) to a lower oxygen saturation limit (≥90%) after 36 weeks PMA in infants diagnosed with moderate or severe BPD. METHODS AND ANALYSIS: This non-blinded, multicentre, randomised controlled trial will recruit 198 preterm born infants with moderate or severe BPD between 36 and 38 weeks PMA. Infants will be randomised to either a lower oxygen saturation limit of 95% or to a lower limit of 90%; supplemental oxygen and/or respiratory support will be weaned based on the assigned lower oxygen saturation limit. Adherence to the oxygen saturation limit will be assessed by extracting oxygen saturation profiles from pulse oximeters regularly, until respiratory support is stopped. The primary outcome is the weight SD score at 6 months of corrected age. Secondary outcomes include anthropometrics collected at 6 and 12 months of corrected age, rehospitalisations, respiratory complaints, infant stress, parental quality of life and cost-effectiveness. ETHICS AND DISSEMINATION: Ethical approval for the trial was obtained from the Medical Ethics Review Committee of the Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2018-1515). Local approval for conducting the trial in the participating hospitals has been or will be obtained from the local institutional review boards. Informed consent will be obtained from the parents or legal guardians of all study participants. TRIAL REGISTRATION NUMBER: NL7149/NTR7347.


Asunto(s)
Displasia Broncopulmonar , Displasia Broncopulmonar/terapia , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Unidades de Cuidado Intensivo Neonatal , Estudios Multicéntricos como Asunto , Oxígeno , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto
10.
BMJ Open ; 12(5): e062192, 2022 05 11.
Artículo en Inglés | MEDLINE | ID: mdl-35545385

RESUMEN

INTRODUCTION: The remarkable improvement in the long-term prognosis of extremely premature infants has led to an increase in the number of cases of bronchopulmonary dysplasia (BPD). BPD affects pulmonary function and developmental outcomes, resulting in high chronic health burdens for infants and their families over the years. Therefore, identifying its risk factors in the early period of life and exploring better prophylactics and treatment strategies are important.The objectives of our scoping review are to screen available evidence, identify perinatal risk factors involved in the development and severity of BPD and devise a novel disease classification system that can predict long-term prognosis. METHODS AND ANALYSIS: Eligibility criteria are as follows: articles published from 2002 to 2021; studies conducted in developed countries; articles written in English (PubMed) or Japanese (Ichushi); randomised controlled trials, prospective/retrospective cohort studies or case-control studies; extremely premature infants born before 28 weeks of gestational age; and articles in which endpoint was severe BPD as classified by the National Institute of Child Health and Human Development.We will screen the titles and abstracts of studies identified by independent reviewers using the population-concept-context framework. After a full-text review and data charting, we will provide the perinatal risk factors for severe BPD along with the risk ratio or odds ratio, 95% confidence interval and p values. ETHICS AND DISSEMINATION: Institutional review board approval is not required due to the nature of the study. The results of this review will be disseminated through peer-reviewed publications and presentations at relevant conferences.Protocol V.1, 22 September 2021 TRIAL REGISTRATION NUMBER: UMIN000045529.


Asunto(s)
Displasia Broncopulmonar , Displasia Broncopulmonar/prevención & control , Niño , Femenino , Edad Gestacional , Humanos , Lactante , Recien Nacido Extremadamente Prematuro , Recién Nacido , Embarazo , Estudios Prospectivos , Estudios Retrospectivos , Literatura de Revisión como Asunto , Factores de Riesgo
11.
BMJ Open ; 12(5): e058950, 2022 05 12.
Artículo en Inglés | MEDLINE | ID: mdl-35551084

RESUMEN

OBJECTIVE: The aim of this qualitative study was to use a theory-based approach to understand the facilitators and barriers that impacted the implementation of the Primary Care Asthma Paediatric Pathway. DESIGN: Qualitative semistructured focus groups following a randomised cluster-controlled design. SETTING: 22 primary care practices in Alberta, Canada. PARTICIPANTS: 37 healthcare providers participated in four focus groups to discuss the barriers and facilitators of pathway implementation. INTERVENTION: An electronic medical record (EMR) based paediatric asthma pathway, online learning modules, in-person training for allied health teams in asthma education, and a clinical dashboard for patient management. MAIN OUTCOME MEASURES: Our qualitative findings are organised into three themes using the core constructs of the normalisation process theory: (1) Facilitators of implementation, (2) Barriers to implementation, and (3) Proposed mitigation strategies. RESULTS: Participants were positive about the pathway, and felt it served as a reminder of paediatric guideline-based asthma management, and an EMR-based targeted collection of tools and resources. Barriers included a low priority of paediatric asthma due to few children with asthma in their practices. The pathway was not integrated into clinic flow and there was not a specific process to ensure the pathway was used. Sites without project champions also struggled more with implementation. Despite these barriers, clinicians identified mitigation strategies to improve uptake including developing a reminder system within the EMR and creating a workflow that incorporated the pathway. CONCLUSION: This study demonstrated the barriers and facilitators shaping the asthma pathway implementation. Our findings highlighted that if team support of enrolment (establishing buy-in), legitimisation (ensuring teams see their role in the pathway) and activation (an ongoing plan for sustainability) there may have been greater uptake of the pathway. TRIAL REGISTRATION NUMBER: This study was registered at clinicaltrials.gov on 25 June 2015; the registration number is: NCT02481037, https://clinicaltrials.gov/ct2/show/NCT02481037?term=andrew+cave&cond=Asthma+in+Children&cntry=CA&city=Edmonton&draw=2&rank=1.


Asunto(s)
Asma , Personal de Salud , Alberta , Asma/terapia , Niño , Humanos , Atención Primaria de Salud , Investigación Cualitativa
12.
BMJ Open ; 12(4): e054762, 2022 04 13.
Artículo en Inglés | MEDLINE | ID: mdl-35418427

RESUMEN

INTRODUCTION: Previous randomised controlled trials (RCTs) suggest antibiotics for treating episodes of asthma-like symptoms in preschool children. Further, high-dose vitamin D supplementation has been shown to reduce the rate of asthma exacerbations among adults with asthma, while RCTs in preschool children are lacking. The aims of this combined RCT are to evaluate treatment effect of azithromycin on episode duration and the preventive effect of high-dose vitamin D supplementation on subsequent episodes of asthma-like symptoms among hospitalised preschoolers. METHODS AND ANALYSIS: Eligible participants, 1-5 years old children with a history of recurrent asthma-like symptoms hospitalised due to an acute episode, will be randomly allocated 1:1 to azithromycin (10 mg/kg/day) or placebo for 3 days (n=250). Further, independent of the azithromycin intervention participants will be randomly allocated 1:1 to high-dose vitamin D (2000 IU/day+ standard dose 400 IU/day) or standard dose (400 IU/day) for 1 year (n=320). Participants are monitored with electronic diaries for asthma-like symptoms, asthma medication, adverse events and sick-leave. The primary outcome for the azithromycin intervention is duration of asthma-like symptoms after treatment. Secondary outcomes include duration of hospitalisation and antiasthmatic treatment. The primary outcome for the vitamin D intervention is the number of exacerbations during the treatment period. Secondary outcomes include time to first exacerbation, symptom burden, asthma medication and safety. ETHICS AND DISSEMINATION: The RCTs are approved by the Danish local ethical committee and conducted in accordance with the guiding principles of the Declaration of Helsinki. The Danish Medicines Agency has approved the azithromycin RCT, which is monitored by the local Unit for Good Clinical Practice. The vitamin D RCT has been reviewed and is not considered a medical intervention. Results will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBERS: NCT05028153, NCT05043116.


Asunto(s)
Asma , Azitromicina , Asma/tratamiento farmacológico , Asma/prevención & control , Azitromicina/uso terapéutico , Preescolar , Método Doble Ciego , Humanos , Lactante , Ensayos Clínicos Controlados Aleatorios como Asunto , Vitamina D/uso terapéutico , Vitaminas/uso terapéutico
13.
BMJ Open ; 12(2): e052058, 2022 02 07.
Artículo en Inglés | MEDLINE | ID: mdl-35131821

RESUMEN

OBJECTIVE: The WHO Global School Health Initiative aimed to improve child and community health through health promotion programmes in schools, though most focus on preventing communicable disease. Despite WHO recommendations, no asthma programme is included in the Malaysian national school health service guideline. Therefore, we aimed to explore the views of school staff, healthcare professionals and policy-makers about the challenges of managing asthma in schools and the potential of a school asthma programme for primary school children. DESIGN: A focus group and individual interview qualitative study using purposive sampling of participants to obtain diverse views. Data collection was guided by piloted semistructured topic guides. The focus groups and interviews were audiorecorded, transcribed verbatim and analysed using inductive thematic analysis. We completed data collection once data saturation was reached. SETTING: Stakeholders in education and health sectors in Malaysia. PARTICIPANTS: Fifty-two participants (40 school staff, 9 healthcare professionals and 3 policy-makers) contributed to nine focus groups and eleven individual interviews. RESULTS: School staff had limited awareness of asthma and what to do in emergencies. There was no guidance on asthma management in government schools, and teachers were unclear about their role in school children's health. These uncertainties led to delays in the treatment of asthma symptoms/attacks, and suggestions that an asthma education programme and a school plan would improve asthma care. Perceived challenges in conducting school health programmes included a busy school schedule and poor parental participation. A tailored asthma programme in partnerships with schools could facilitate the programme's adoption and implementation. CONCLUSIONS: Identifying and addressing issues and challenges specific to the school and wider community could facilitate the delivery of a school asthma programme in line with the WHO School Health Initiative. Clarity over national policy on the roles and responsibilities of school staff could support implementation and guide appropriate and prompt response to asthma emergencies in schools.


Asunto(s)
Asma , Instituciones Académicas , Asma/prevención & control , Niño , Humanos , Malasia , Investigación Cualitativa , Servicios de Salud Escolar
14.
BMJ Open ; 12(2): e054952, 2022 Feb 22.
Artículo en Inglés | MEDLINE | ID: mdl-35193916

RESUMEN

PURPOSE: The risk of developing asthma-like symptoms and asthma in childhood is influenced by genetics, environmental exposures, prenatal and early postnatal events, and their interactions. The cohort name refers to vitamins A and D, and nitric oxide (NO) spelt backwards and this cohort profile paper aims to present the data collection and aim of the cohort.The overall aim when establishing this cohort was to investigate if childhood lung function can be traced back to early neonatal lung function and fractional exhaled NO (FeNO) and investigate prenatal and postnatal risk factors including maternal and neonatal vitamin A and D levels in preterm and term born children. PARTICIPANTS: One thousand five hundred women and their babies born at Nordsjaellands Hospital in Denmark from 2013 to 2014 were included in the AD-ON research biobank prior to birth.Neonates from the AD-ON research biobank, admitted to the Neonatal Intensive Care Unit at Nordsjaellands Hospital, were included in the AD-ON neonatal cohort. The neonatal cohort consisted of 149 neonates hereof 63 preterm and 86 term born. The children in the cohort have been invited to follow-up visits at age 1 and 6 years. FINDINGS TO DATE: Published data from this cohort includes a validated and clinically applicable method to measure FeNO in neonates. We found an age-specific pattern of association between respiratory symptoms at age 1 and neonatal FeNO in preterm children. Moreover, we found that the respiratory symptoms risk was associated with postnatal factors (Respiratory Syncytial Virus infection and parental smoking) in preterm infants and prenatal factors (parental asthma and maternal infection during pregnancy) in term born infants. FUTURE PLANS: In the future, the children will be examined continuously with 3-year to 5-year intervals until the age of 18. Lung function, allergy tests, environmental exposure measurements and questionnaires will be collected at each follow-up visit.


Asunto(s)
Asma , Óxido Nítrico , Asma/epidemiología , Niño , Preescolar , Dinamarca/epidemiología , Femenino , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Pulmón , Embarazo , Vitamina A , Vitaminas
15.
BMJ Open ; 12(1): e055628, 2022 Jan 19.
Artículo en Inglés | MEDLINE | ID: mdl-35046004

RESUMEN

INTRODUCTION: Endotracheal tube (ETT) insertion depth estimation is important for optimal placement of ETT tip and balanced ventilation of the lungs. Various methods are available to determine the ETT insertion depth. The Neonatal Resuscitation Programme recommends the gestational age and nasal-tragus length (NTL) methods for estimating ETT insertion depth during cardiopulmonary resuscitation. However, the prospective data comparing these two methods is lacking. METHODS AND ANALYSIS: This is an open-label multi-centre randomised controlled trial, where gestational age and NTL methods will be used to determine the initial ETT insertion depth in term and preterm infants that are less than 28 days old, requiring oral intubation in the delivery room or neonatal intensive care unit (NICU). SITES AND SAMPLE SIZE: The trial is aimed to recruit 454 infants over 3 years across tertiary level NICUs. OUTCOMES: The primary outcome includes an optimally positioned ETT, defined as an ETT tip between the upper border of the first thoracic vertebra and the lower border of the second thoracic vertebra. The outcome is assessed by a paediatric radiologist, who will be masked to the group assignment. Secondary outcomes are malpositioned ETT tips, pneumothorax, ETT repositioning, chronic lung disease, invasive ventilation days, and death. ANALYSIS: Data will be analysed using the intention-to-treat principle. The primary and categorical secondary outcomes will be compared using the χ2 test. Adjusted risk ratios of outcomes will be calculated along with 95% CIs through multivariable logistic regression analysis, including covariates deemed biologically to influence the outcomes. ETHICS AND DISSEMINATION: The study has been approved by the PNU Research Ethics Board (20-0148) and the respective ethical review boards of the participating centres. The results will be disseminated through conference meetings, social media platforms, and publications in scientific journals. TRIAL REGISTRATION NUMBER: NCT04393337.


Asunto(s)
Recien Nacido Prematuro , Resucitación , Niño , Edad Gestacional , Humanos , Lactante , Recién Nacido , Intubación Intratraqueal/métodos , Estudios Multicéntricos como Asunto , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resucitación/métodos
16.
Postgrad Med J ; 98(1157): 183-186, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33273110

RESUMEN

BACKGROUND: Asthma, a common childhood condition, often presents with chronic cough. While evaluating for chronic cough, many specialists obtain a baseline chest radiograph (CR) to assess for other causes. Usually read as 'normal', sometimes CRs will reveal evidence of airway inflammation in the form of subtle findings, such as 'increased interstitial markings' or 'peribronchial thickening'. There is sparse literature in the outpatient setting correlating findings on baseline CRs with adverse outcomes such as systemic steroid use, emergency department (ED) visit or hospitalisation. METHODS: This was a retrospective study of patients seen at our institution's Pediatric Pulmonology outpatient clinic. We reviewed the charts of all new patients aged 0-18 years who presented between January 2015 and December 2017. Patients were included if they were diagnosed with asthma, had a CR after the initial visit and were followed up at least twice. Adverse outcomes include systemic steroid use, ED visit or hospitalisation. RESULTS: 130 subjects were included. 89 subjects had clear CRs and 41 subjects had CRs with airway inflammation. Overall events were higher in the airway inflammation group (22.5% vs 46.3%, respectively, p<0.0058). There were no significant differences between in terms of oral corticosteroid use or hospitalisations. There was a significant difference between the two groups in terms of ED visits (2.2% vs 14.6%, respectively, p=0.0121). CONCLUSION: This study shows a positive correlation between airway inflammation findings on baseline CR and subsequent ED visits in patients with asthma.


Asunto(s)
Asma , Adolescente , Corticoesteroides/uso terapéutico , Asma/tratamiento farmacológico , Niño , Preescolar , Servicio de Urgencia en Hospital , Humanos , Lactante , Recién Nacido , Estudios Retrospectivos , Rayos X
17.
BMJ Open ; 12(12): e062979, 2022 12 20.
Artículo en Inglés | MEDLINE | ID: mdl-36600434

RESUMEN

INTRODUCTION: A considerable burden of the tuberculosis (TB) epidemic is found in adolescents. The reasons for increased susceptibility to TB infection and higher incidence of TB disease in adolescence, compared with the 5-10 years old age group, are incompletely understood. Despite the pressing clinical and public health need to better understand and address adolescent TB, research in this field remains limited. METHODS AND ANALYSIS: Teen TB is an ongoing prospective observational cohort study that aims to better understand the biology, morbidity and social context of adolescent TB. The study plans to recruit 50 adolescents (10-19 years old) with newly diagnosed microbiologically confirmed pulmonary TB disease and 50 TB-exposed controls without evidence of TB disease in Cape Town, South Africa, which is highly endemic for TB. At baseline, cases and controls will undergo a detailed clinical evaluation, chest imaging, respiratory function assessments and blood collection for viral coinfections, inflammatory cytokines and pubertal hormone testing. At 2 weeks, 2 months and 12 months, TB disease cases will undergo further chest imaging and additional lung function testing to explore the patterns of respiratory abnormalities. At week 2, cases will complete a multicomponent quantitative questionnaire about psychological and social impacts on their experiences and longitudinal, in-depth qualitative data will be collected from a nested subsample of 20 cases and their families. ETHICS AND DISSEMINATION: The study protocol has received ethical approval from the Stellenbosch University Health Research Ethics Committee (N19/10/148). The study findings will be disseminated through peer-reviewed publications, academic conferences and formal presentations to health professionals. Results will also be made available to participants and caregivers.


Asunto(s)
Tuberculosis , Adolescente , Humanos , Preescolar , Niño , Adulto Joven , Adulto , Estudios Prospectivos , Sudáfrica/epidemiología , Tuberculosis/epidemiología , Incidencia , Medio Social , Biología , Estudios Observacionales como Asunto
19.
BMJ Open ; 11(12): e049007, 2021 12 22.
Artículo en Inglés | MEDLINE | ID: mdl-34937712

RESUMEN

INTRODUCTION: Bronchiectasis is no longer considered rare or irreversible in children, yet it remains relatively under-researched and neglected in respiratory health globally. Bronchiectasis (including chronic suppurative lung disease) causes substantial morbidity for patients and significant impact on caregivers, especially during acute respiratory exacerbations. In other chronic respiratory diseases (eg, asthma), empowering consumers with an individualised plan for management of acute exacerbations improves clinical outcomes. However, in the absence of any such data specific to bronchiectasis, action management plans are rarely currently used in children or adults with bronchiectasis. We hypothesise that providing an individualised bronchiectasis action management plan (BAMP) to children with bronchiectasis reduces non-scheduled doctor consultations, compared with not having a BAMP. METHODS AND ANALYSIS: This multicentre, parallel, double-blind, randomised trial involving three urban Australian hospitals commenced in June 2018 and will include 198 children, aged <19 years with bronchiectasis who had 2 or more exacerbations in the previous 18 months. Children will be randomised to having an individualised BAMP or standard care (a decoy clinic letter). Primary caregivers will then be followed up monthly for 12 months. The primary outcome is the rate of acute non-scheduled doctor visits for respiratory exacerbations by 12 months. The main secondary outcomes are cough-specific quality of life scores at 6 and 12 months, overall exacerbation rate over 12 months, and proportion of children who received timely influenza vaccination by 30 May annually. ETHICS AND DISSEMINATION: The Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Heath Research and Queensland Children's Hospital approved the study. The results of the trial will be submitted for publication and the BAMP made available free online. TRIAL REGISTRATION NUMBER: Australia and New Zealand Clinical Trials Register ACTRN12618000604202.


Asunto(s)
Bronquiectasia , Calidad de Vida , Adolescente , Antibacterianos/uso terapéutico , Bronquiectasia/terapia , Niño , Progresión de la Enfermedad , Método Doble Ciego , Humanos , Estudios Multicéntricos como Asunto , Northern Territory , Ensayos Clínicos Controlados Aleatorios como Asunto
20.
BMJ Open ; 11(12): e051561, 2021 12 20.
Artículo en Inglés | MEDLINE | ID: mdl-34930732

RESUMEN

OBJECTIVE: Exploration of the factors that influence hospital doctors' antibiotic prescribing decisions when treating children with respiratory symptoms in UK emergency departments. METHODS: A qualitative study using semistructured interviews based on a critical incident technique with 21 physicians of different grades and specialties that treat children in the UK. Interviews were audio-recorded then transcribed verbatim and analysed using thematic analysis. RESULTS: Four themes were identified. These themes illustrate factors which influence clinician prescribing. The three principal themes were authorities, pressures and risk. The fourth transcending theme that ran through all themes was clinician awareness and complicity ('knowing but still doing'). CONCLUSIONS: Hospital doctors prescribe antibiotics even when they know they should not. This appears to be due to the influence of those in charge or external pressures experienced while weighing up the immediate and longer term risks but clinicians do this with full insight into their actions. These findings have implications for invested parties seeking to develop future antimicrobial stewardship programmes. It is recommended that stewardship interventions acknowledge and target these themes which may in turn facilitate behaviour change and antimicrobial prescribing practice in emergency departments.


Asunto(s)
Antibacterianos , Programas de Optimización del Uso de los Antimicrobianos , Antibacterianos/uso terapéutico , Niño , Servicio de Urgencia en Hospital , Humanos , Pautas de la Práctica en Medicina , Investigación Cualitativa , Reino Unido
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