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BACKGROUND: Supplemental O2 is not always available at health facilities in low-income and middle-income countries (LMICs). Solar-powered O2 delivery can overcome gaps in O2 access, generating O2 independent of grid electricity. We hypothesized that installation of solar-powered O2 systems on the paediatrics ward of rural Ugandan hospitals would lead to a reduction in mortality among hypoxaemic children. METHODS: In this pragmatic, country-wide, stepped-wedge, cluster randomised controlled trial, solar-powered O2 systems (ie, photovoltaic cells, battery bank, and O2 concentrator) were sequentially installed at 20 rural health facilities in Uganda. Sites were selected for inclusion based on the following criteria: District Hospital or Health Centre IV with paediatric inpatient services; supplemental O2 on the paediatric ward was not available or was unreliable; and adequate space to install solar panels, a battery bank, and electrical wiring. Allocation concealment was achieved for sites up to 2 weeks before installation, but the study was not masked overall. Children younger than 5 years admitted to hospital with hypoxaemia and respiratory signs were included. The primary outcome was mortality within 48 h of detection of hypoxaemia. The statistical analysis used a linear mixed effects logistic regression model accounting for cluster as random effect and calendar time as fixed effect. The trial is registered at ClinicalTrials.gov, NCT03851783. FINDINGS: Between June 28, 2019, and Nov 30, 2021, 2409 children were enrolled across 20 hospitals and, after exclusions, 2405 children were analysed. 964 children were enrolled before site randomisation and 1441 children were enrolled after site randomisation (intention to treat). There were 104 deaths, 91 of which occurred within 48 h of detection of hypoxaemia. The 48 h mortality was 49 (5·1%) of 964 children before randomisation and 42 (2·9%) of 1440 (one individual did not have vital status documented at 48 h) after randomisation (adjusted odds ratio 0·50, 95% CI 0·27-0·91, p=0·023). Results were sensitive to alternative parameterisations of the secular trend. There was a relative risk reduction of 48·7% (95% CI 8·5-71·5), and a number needed to treat with solar-powered O2 of 45 (95% CI 28-230) to save one life. Use of O2 increased from 484 (50·2%) of 964 children before randomisation to 1424 (98·8%) of 1441 children after randomisation (p<0·0001). Adverse events were similar before and after randomisation and were not considered to be related to the intervention. The estimated cost-effectiveness was US$25 (6-505) per disability-adjusted life-year saved. INTERPRETATION: This stepped-wedge, cluster randomised controlled trial shows the mortality benefit of improving O2 access with solar-powered O2. This study could serve as a model for scale-up of solar-powered O2 as one solution to O2 insecurity in LMICs. FUNDING: Grand Challenges Canada and The Women and Children's Health Research Institute.
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Hospitalização , Hipóxia , Humanos , Criança , Feminino , Uganda/epidemiologia , Hipóxia/etiologia , Hipóxia/terapia , Projetos de Pesquisa , Instalações de SaúdeRESUMO
WHAT WAS THE EDUCATIONAL CHALLENGE?: Medical students experience high rates of anxiety; frequent examinations are one contributing source. Students may perceive the observed structured clinical examinations (OSCEs) as particularly stressful. Strategies to reduce anxiety during OSCEs have not been described. WHAT WAS THE SOLUTION?: We sought to implement and evaluate a simple, in-the-moment intervention aimed at reducing students' OSCE-related anxiety by making stress-reducing activities available during break stations during a summative pediatric OSCE. HOW WAS THE SOLUTION IMPLEMENTED?: Three break stations were included in an end-of-rotation, summative OSCE. Students were block-randomized to either control group with standard break stations, or intervention group with stress-reducing activities available in the break room. All participants completed the State-Trait Anxiety Inventory (STAI) before and after the OSCE, and a short questionnaire after OSCE completion. WHAT LESSONS WERE LEARNED THAT ARE RELEVANT TO A WIDER GLOBAL AUDIENCE?: Third-year medical students have high levels of stress before and after OSCEs. More than half of students in the intervention group felt their anxiety improved with activities. While the inclusion of stress-reducing activities in break stations did not impact exam performance, some students subjectively felt their performance improved. If OSCE break stations are logistically required, they can be employed to allow students to briefly relax during a high-stress exam without negatively impacting performance. WHAT ARE THE NEXT STEPS?: Next steps include exploration of opportunities for integration of stress-reducing activities during OSCEs with other learner groups, and identification of other stress-inducing aspects of medical training to provide similar opportunities.
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Ansiedade , Avaliação Educacional , Estudantes de Medicina , Humanos , Estudantes de Medicina/psicologia , Avaliação Educacional/métodos , Estresse Psicológico , Competência Clínica , Feminino , Masculino , Educação de Graduação em MedicinaRESUMO
AIMS: To (1) describe six-minute walk test (6MWT) reference values for children with Juvenile Idiopathic Arthritis (JIA) and (2) explore predictors of 6MWT distance. A secondary objective was to determine how 6MWT distances of children with JIA compare to those of children without JIA reported in the literature. METHODS: Demographic, clinical, height, weight and 6MWT data were extracted from clinical records of 120 children with JIA (70.8% female, mean age=12.4 ± 3.2 years) who attended a follow-up rheumatology clinic. A total of 272 6MWTs were included in the analyses. Linear mixed effects modeling was used to determine the relationship between predictive variables and 6MWT distance. 6MWT distances were compared to predicted values using published equations for estimating 6MWT distances in children without JIA. RESULTS: Height, weight, and age were predictive of 6MWT distance (R2 = 0.62). Mean 6MWT distances for children with JIA were lower than those reported for children without JIA (p < 0.001). Mean 6MWT distance was 84% and 78% of predicted values for children without JIA. CONCLUSION: The reference values and associated predictive model have application for assessing exercise capacity in children with JIA.
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Artrite Juvenil , Criança , Teste de Esforço , Feminino , Humanos , Masculino , Valores de Referência , Teste de Caminhada , CaminhadaRESUMO
Access to therapeutic oxygen in low-resource settings remains a significant global problem. Solar powered oxygen (SPO2) delivery is a reliable and cost-effective solution. We followed implementation research methodology to gather data on engineering parameters (remote monitoring), nurse training (before and after knowledge questionnaire), patients treated with SPO2 (descriptive case series), and qualitative user feedback (focus group discussions). In January 2021, SPO2 was installed at Hanano General Hospital in Dusamareb, Galmudug State, Somalia, in a conflict-affected region. Daily photovoltaic cell output (median 8.0 kWh, interquartile range (IQR) 2.6-14) exceeded the electrical load from up to three oxygen concentrators (median 5.0 kWh, IQR 0.90-12). Over the first six months after implementation, 114 patients (age 1 day to 89 years, 54% female) were treated for hypoxaemic illnesses, including COVID-19, pneumonia, neonatal asphyxia, asthma, and trauma. Qualitative end user feedback highlighted SPO2 acceptability. Violent conflict was identified as a contextual factor affecting local oxygen needs. We provide the preliminary findings of this implementation research study and describe the feasibility, fidelity, rapid adoption, usefulness, and acceptability of SPO2 in a low-resource setting characterized by violent conflict during the COVID-19 pandemic. Our findings demonstrated the lifesaving feasibility of SPO2 in volatile settings.
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COVID-19 , Pandemias , Estudos de Viabilidade , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Oxigênio , SomáliaRESUMO
BACKGROUND: Oxygen is an essential therapy for hypoxemia but is scarce in low-income settings. Oxygen conserving devices optimize delivery, but to date have been designed for adults in high-income settings. Here we present the development and clinical pilot study of an oxygen-sparing nasal reservoir cannula (OSNRC) for pediatric use in low-income settings. METHODS: (1) Pre-clinical development of a novel OSNRC using a simulated respiratory circuit with metabolic simulator and anatomically accurate face-airway models. Simulated breathing waveforms were designed based on airway resistance, lung compliance, respiratory rate, and tidal volume of spontaneous breathing for three disease conditions. (2) Pilot, randomized, controlled, non-blinded, cross-over study of the OSNRC vs standard nasal cannula (SNC) among children hospitalized with hypoxemic pneumonia in Uganda. Eight children were randomized to OSNRC followed by SNC, and eight were randomized to SNC followed by OSNRC. RESULTS: The laboratory simulation showed that the OSNRC provided the same or higher fraction of inspired oxygen at approximately 2.5-times lower flow rate compared to SNC. The flow savings ratio exhibited a linear relationship with the OSNRC volume to tidal volume ratio with a slope that varied with breathing waveforms. The range of performance from different breathing waveforms defined a performance envelope of the OSNRC. Two mask sizes (30 mL and 50 mL) provided sufficient coverage for patients between the 3rd and 97th percentile in our targeted age range. In the clinical pilot study, the rise in capillary blood pCO2 was similar in the OSNRC and SNC groups, suggesting that the OSNRC was not associated with CO2 retention. There were no significant differences between OSNRC and SNC with respect to clinical adverse events, lactate levels, pH, and SpO2. The OSNRC group had a higher mean SpO2 than the SNC group (adjusted mean difference, 1.4, 95% confidence interval 1.1 to 1.8), showing oxygen delivery enhancement. CONCLUSION: The OSNRC enhances oxygen delivery without causing CO2 retention and appears to be well-tolerated by pediatric patients. If safety, efficacy and tolerability are confirmed in larger trials, this device has the potential to optimize oxygen delivery in children in low-resource settings, reducing the global burden of pediatric pneumonia. TRIAL REGISTRATION: The trial was retrospectively registered (International Standard Registered Clinical/Social Study Number (ISRCTN): 15216845 ; Date of registration: 15 July 2020).
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Cânula , Hipóxia/terapia , Oxigenoterapia/instrumentação , Oxigênio/sangue , Pneumonia/terapia , Pré-Escolar , Estudos Cross-Over , Feminino , Humanos , Hipóxia/etiologia , Masculino , Nariz , Projetos Piloto , Volume de Ventilação Pulmonar , UgandaRESUMO
OBJECTIVE: To examine the temporal course of lung aeration at birth in preterm infants <33 weeks gestation. STUDY DESIGN: The research team attended deliveries of preterm infants <33 weeks gestation at the Royal Alexandra Hospital. Infants who received only continuous positive airway pressure were eligible for inclusion. A combined carbon dioxide (CO2) and flow-sensor was placed between the mask and the ventilation device. To analyze lung aeration patterns during spontaneous breathing, tidal volume (VT), and exhaled CO2 (ECO2) were recorded for the first 100 breaths. RESULTS: Thirty preterm infants were included with a total of 1512 breaths with mask leak <30%. Mean (SD) gestational age and birth weight was 30 (1) weeks and 1478 (430) g. Initial VT and ECO2 for the first 30 breaths was 5-6 mL/kg and 15-22 mm Hg, respectively. VT and ECO2 increased over the next 20 breaths to 7-8 mL/kg and 25-32 mm Hg, respectively. For the remaining observation period VT decreased to 4-6 mL/kg and ECO2 continued to increase to 35-37 mm Hg. CONCLUSIONS: Preterm infants begin taking deeper breaths approximately 30 breaths after initiating spontaneous breathing to inflate their lungs. Concurrent CO2 removal rises as alveoli are recruited. Lung aeration occurs in 2 phases: initially, large volume breaths with poor alveolar aeration followed by smaller breaths with elimination of CO2 as a consequence of adequate aeration.
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Dióxido de Carbono/metabolismo , Recém-Nascido Prematuro/fisiologia , Pulmão/fisiologia , Respiração , Canadá , Pressão Positiva Contínua nas Vias Aéreas , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Pulmão/metabolismo , Masculino , Volume de Ventilação Pulmonar/fisiologiaRESUMO
OBJECTIVE: To describe changes in tidal volume (VT) and their correlation to changes in oxygen saturation and heart rate in spontaneously breathing preterm infants immediately after birth. STUDY DESIGN: In this prospective observational, 2-center study, a flow sensor was attached to the facemask of spontaneously breathing infants born at <37 weeks' gestational age who received continuous positive airway pressure (CPAP) immediately after birth. Respiratory function, heart rate, and oxygen saturation were continuously recorded during spontaneous breathing. RESULTS: Fifty-five infants (mean [SD] gestational age 31 [26-36] weeks and birth weight 1647 [500] g) received mask CPAP in the delivery room. CPAP was started at a median (IQR) 90 (60-118) seconds after birth and was delivered for 720 (300-900) seconds. Median VT ranged between 4.2 and 5.8 mL/kg with the individual VT varied between 0.9 and 19.8 mL/kg. Overall, VT increased over the first few minutes after birth and decreased thereafter. The increase in saturation after birth lagged behind the published normal ranges for spontaneously breathing preterm infants without CPAP. CONCLUSIONS: The 50th percentile for spontaneous VT in preterm infants during mask CPAP ranged from 4.2 to 5.8 mL/kg, with wide individual variation observed in the first minutes after birth. Preterm infants requiring CPAP after birth may take longer to achieve so-called "normal" saturation targets.
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Pressão Positiva Contínua nas Vias Aéreas/métodos , Volume de Ventilação Pulmonar/fisiologia , Feminino , Frequência Cardíaca , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Máscaras , Monitorização Fisiológica , Oxigênio/sangue , Oxigênio/uso terapêutico , Estudos Prospectivos , Respiração , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: Hospitalized children are a potentially underimmunized population. We sought to determine the proportion of patients admitted to our pediatric medicine inpatient units who are underimmunized or unimmunized and to identify barriers to immunization faced by families of children admitted to hospital. METHODS: We conducted a prospective study of children aged 2 months to 18 years admitted to our pediatric medicine inpatient units between July 2021 and October 2022. Immunization and demographic data were collected from electronic medical charts. Immunization status of each child was categorized as up-to-date if they had received all eligible vaccine doses in accordance with the provincial immunization schedule. Caregivers completed a survey on barriers to immunizations; results were compared between caregivers of children whose vaccines were up-to-date and those who were not. RESULTS: Hospitalized children were missing more doses of the preschool vaccines than the general population based on published provincial data. Only 142 of 244 (58.2%) of study patients were up-to-date on all their immunizations. Caregivers of children whose immunizations were not up-to-date reported significantly more barriers to vaccination in all survey categories: access to shots, concerns about shots, and importance of shots. CONCLUSIONS: There is a disparity in immunization status between children admitted to hospital in a Canadian setting compared with national targets and community immunization rates. Caregivers of underimmunized hospitalized children cited significantly more barriers to immunization when compared with hospitalized children who are up-to-date. Pursuing a hospital-based immunization strategy could lead to improved immunization status for hospitalized children.
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Importance: Pneumonia is the leading cause of childhood mortality worldwide. Severe pneumonia associated with hypoxemia requires oxygen therapy; however, access remains unreliable in low- and middle-income countries. Solar-powered oxygen delivery (solar-powered O2) has been shown to be a safe and effective technology for delivering medical oxygen. Examining the cost-effectiveness of this innovation is critical for guiding implementation in low-resource settings. Objective: To determine the cost-effectiveness of solar-powered O2 for treating children in low-resource settings with severe pneumonia who require oxygen therapy. Design, Setting, and Participants: An economic evaluation study of solar-powered O2 was conducted from January 12, 2020, to February 27, 2021, in compliance with the World Health Organization Choosing Interventions That Are Cost-Effective (WHO-CHOICE) guidelines. Using existing literature, plausible ranges for component costs of solar-powered O2 were determined in order to calculate the expected total cost of implementation. The costs of implementing solar-powered O2 at a single health facility in low- and middle-income countries was analyzed for pediatric patients younger than 5 years who required supplemental oxygen. Exposures: Treatment with solar-powered O2. Main Outcomes and Measures: The incremental cost-effectiveness ratio (ICER) of solar-powered O2 was calculated as the additional cost per disability-adjusted life-year (DALY) saved. Sensitivity of the ICER to uncertainties of input parameters was assessed through univariate and probabilistic sensitivity analyses. Results: The ICER of solar-powered O2 was estimated to be $20 (US dollars) per DALY saved (95% CI, $2.83-$206) relative to the null case (no oxygen). Costs of solar-powered O2 were alternatively quantified as $26 per patient treated and $542 per life saved. Univariate sensitivity analysis found that the ICER was most sensitive to the volume of pediatric pneumonia admissions and the case fatality rate. The ICER was insensitive to component costs of solar-powered O2 systems. In secondary analyses, solar-powered O2 was cost-effective relative to grid-powered concentrators (ICER $140 per DALY saved) and cost-saving relative to fuel generator-powered concentrators (cost saving of $7120). Conclusions and Relevance: The results of this economic evaluation suggest that solar-powered O2 is a cost-effective solution for treating hypoxemia in young children in low- and middle-income countries, relative to no oxygen. Future implementation should prioritize sites with high rates of pediatric pneumonia admissions and mortality. This study provides economic support for expansion of solar-powered O2 and further assessment of its efficacy and mortality benefit.
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Recursos em Saúde/provisão & distribuição , Oxigenoterapia/instrumentação , Pneumonia/terapia , Energia Solar/economia , Análise Custo-Benefício/métodos , Análise Custo-Benefício/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Oxigênio/administração & dosagem , Oxigênio/economia , Oxigenoterapia/métodos , Energia Solar/estatística & dados numéricosRESUMO
BACKGROUND AND OBJECTIVES: Delivery of inadvertent high tidal volume (VT) during positive pressure ventilation (PPV) in the delivery room is common. High VT delivery during PPV has been associated with haemodynamic brain injury in animal models. We examined if VT delivery during PPV at birth is associated with brain injury in preterm infants <29 weeks' gestation. METHODS: A flow-sensor was placed between the mask and the ventilation device. VT values were compared with recently described reference ranges for VT in spontaneously breathing preterm infants at birth. Infants were divided into two groups: VT<6 mL/kg or VT>6 mL/kg (normal and high VT, respectively). Brain injury (eg, intraventricular haemorrhage (IVH)) was assessed using routine ultrasound imaging within the first days after birth. RESULTS: A total of 165 preterm infants were included, 124 (75%) had high VT and 41 (25%) normal VT. The mean (SD) gestational age and birth weight in high and normal VT group was similar, 26 (2) and 26 (1) weeks, 858 (251) g and 915 (250) g, respectively. IVH in the high VT group was diagnosed in 63 (51%) infants compared with 5 (13%) infants in the normal VT group (P=0.008).Severe IVH (grade III or IV) developed in 33/124 (27%) infants in the high VT group and 2/41 (6%) in the normal VT group (P=0.01). CONCLUSIONS: High VT delivery during mask PPV at birth was associated with brain injury. Strategies to limit VT delivery during mask PPV should be used to prevent high VT delivery.
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Hemorragia Cerebral/etiologia , Salas de Parto/organização & administração , Doenças do Prematuro/etiologia , Recém-Nascido Prematuro , Ventilação com Pressão Positiva Intermitente/efeitos adversos , Ventilação com Pressão Positiva Intermitente/métodos , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Masculino , Volume de Ventilação PulmonarRESUMO
BACKGROUND: Child mortality due to pneumonia is a major global health problem and is associated with hypoxemia. Access to safe and continuous oxygen therapy can reduce mortality; however, low-income countries may lack the necessary resources for oxygen delivery. We have previously demonstrated proof-of-concept that solar-powered oxygen (SPO2) delivery can reliably provide medical oxygen remote settings with minimal access to electricity. This study aims to demonstrate the efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness across Uganda. METHODS: Objectives: Demonstrate efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness. STUDY DESIGN: Multi-center, stepped-wedge cluster-randomized trial. SETTING: Twenty health facilities across Uganda, a low-income, high-burden country for pediatric pneumonia. Site selection: Facilities with pediatric inpatient services lacking consistent O2 supply on pediatric wards. PARTICIPANTS: Children aged < 5 years hospitalized with hypoxemia (saturation < 92%) warranting hospital admission based on clinical judgement. Randomization methods: Random installation order generated a priori with allocation concealment. Study procedure: Patients receive standard of care within pediatric wards with or without SPO2 system installed. OUTCOME MEASURES: Primary: 48-h mortality. Secondary: safety, efficacy, SPO2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration. Statistical analysis of primary outcome: Linear mixed effects logistic regression model with 48-h mortality (dependent variable) as a function of SPO2 treatment (before versus after installation), while adjusting for confounding effects of calendar time (fixed effect) and site (random effect). SAMPLE SIZE: 2400 patients across 20 health facilities, predicted to provide 80% power to detect a 35% reduction in mortality after introduction of SPO2, based on a computer simulation of > 5000 trials. DISCUSSION: Overall, our study aims to demonstrate mortality benefit of SPO2 relative to standard (unreliable) oxygen delivery. The innovative trial design (stepped-wedge, cluster-randomized) is supported by a computer simulation. Capacity building for nursing care and oxygen therapy is a non-scientific objective of the study. If successful, SPO2 could be scaled across a variety of resource-constrained remote or rural settings in sub-Saharan Africa and beyond. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03851783. Registered on 22 February 2019.