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1.
Pediatrics ; 148(2)2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34272343

RESUMO

BACKGROUND: Treating respiratory distress in newborns is expensive. We compared the cost-effectiveness of 2 common noninvasive therapies, nasal continuous positive airway pressure (CPAP) and nasal high-flow (nHF), for newborn infants cared for in nontertiary special care nurseries. METHODS: The economic evaluation was planned alongside a randomized control trial conducted in 9 Australian special care nurseries. Costs were considered from a hospital perspective until infants were 12 months of age. A total of 754 infants with respiratory distress, born ≥31 weeks' gestation and with birth weight ≥1200 g, <24 hours old, requiring noninvasive respiratory support and/or supplemental oxygen for >1 hour were recruited during 2015-2017. Inpatient costing records were obtained for 753 infants, of whom 676 were included in the per-protocol analysis. Two scenarios were considered: (1) CPAP versus nHF, with infants in the nHF group having "rescue" CPAP backup available (trial scenario); and (2) CPAP versus nHF, as sole primary support (hypothetical scenario). Effectiveness outcomes were rate of endotracheal intubation and transfer to a tertiary-level NICU. RESULTS: As sole primary support, CPAP is more effective and on average cheaper, and thus is superior. However, nHF with back-up CPAP produced equivalent cost and effectiveness results, and there is no reason to make a decision between the 2 treatments on the basis of the cost or effectiveness outcomes. CONCLUSIONS: Nontertiary special care nurseries choosing to use only 1 of the modes should choose CPAP. In units with both modes available, using nHF as first-line therapy may be acceptable if there is back-up CPAP.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/economia , Análise Custo-Benefício , Oxigenoterapia/economia , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Feminino , Humanos , Recém-Nascido , Masculino , Nariz , Berçários para Lactentes , Oxigenoterapia/métodos , Estudos Prospectivos
2.
BMJ Open ; 10(9): e037507, 2020 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-32912950

RESUMO

OBJECTIVES: It is unclear how newer methods of respiratory support for infants born extremely preterm (EP; 22-27 weeks gestation) have affected in-hospital sequelae. We aimed to determine changes in respiratory support, survival and morbidity in EP infants since the early 1990s. DESIGN: Prospective longitudinal cohort study. SETTING: The State of Victoria, Australia. PARTICIPANTS: All EP births offered intensive care in four discrete eras (1991-1992 (24 months): n=332, 1997 (12 months): n=190, 2005 (12 months): n=229, and April 2016-March 2017 (12 months): n=250). OUTCOME MEASURES: Consumption of respiratory support, survival and morbidity to discharge home. Cost-effectiveness ratios describing the average additional days of respiratory support associated per additional survivor were calculated. RESULTS: Median duration of any respiratory support increased from 22 days (1991-1992) to 66 days (2016-2017). The increase occurred in non-invasive respiratory support (2 days (1991-1992) to 51 days (2016-2017)), with high-flow nasal cannulae, unavailable in earlier cohorts, comprising almost one-half of the duration in 2016-2017. Survival to discharge home increased (68% (1991-1992) to 87% (2016-2017)). Cystic periventricular leukomalacia decreased (6.3% (1991-1992) to 1.2% (2016-2017)), whereas retinopathy of prematurity requiring treatment increased (4.0% (1991-1992) to 10.0% (2016-2017)). The average additional costs associated with one additional infant surviving in 2016-2017 were 200 (95% CI 150 to 297) days, 326 (183 to 1127) days and 130 (70 to 267) days compared with 1991-1992, 1997 and 2005, respectively. CONCLUSIONS: Consumption of resources for respiratory support has escalated with improved survival over time. Cystic periventricular leukomalacia reduced in incidence but retinopathy of prematurity requiring treatment increased. How these changes translate into long-term respiratory or neurological function remains to be determined.


Assuntos
Lactente Extremamente Prematuro , Doenças do Prematuro , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Doenças do Prematuro/epidemiologia , Doenças do Prematuro/terapia , Estudos Longitudinais , Gravidez , Estudos Prospectivos , Vitória
3.
Ann Thorac Surg ; 110(4): 1372-1378, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32114050

RESUMO

BACKGROUND: Surgery is the cornerstone of treatment for single-ventricle patients, but life just begins for most when the staged procedures are completed. A package of care, including primary care, out-of-hospital specialist visits, and medication, is required for patients living with Fontan. This study quantified the current state of out-of-hospital health care use across childhood for Fontan patients using evidence from Australia. METHODS: Patients recruited from the Fontan Registry were linked with the administrative Medicare (universal health insurance) data. Frequency of medical and pharmaceutical care and costs were estimated. RESULTS: Data for 115 patients with 12,726 medical and 8,336 pharmaceutical claims were obtained. From age 0 to 20 years, patients on average visited a general practitioner an estimated 6.4 times per year (95% confidence interval [CI], 5.9-7.0 times per year), and specialists, including cardiologists, 2.8 times per year (95% CI, 2.5-3.0 times per year). Average use of allied health professional care peaked at age 6 to 9 years (1.0 visits per year; 95% CI, 0.7-1.4 visits per year) with psychologic services being most prominent. For pharmaceuticals, an average of 13.3 prescriptions filled per patient per year throughout childhood was observed (95% CI, 12.4-14.2 prescriptions per year). Overall, out-of-hospital doctor visits of all types averaged 11 visits per year from birth to 20 years. A decline in care was observed when patients reached 18 years across services. CONCLUSIONS: Patterns of out-of-hospital health care use were observed; however, current guidelines are silent about whether this is optimal. Further research is needed to better understand the comprehensive needs of this population.


Assuntos
Assistência Ambulatorial , Atenção à Saúde , Técnica de Fontan , Cardiopatias Congênitas/cirurgia , Atenção Primária à Saúde , Adolescente , Austrália , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Sistema de Registros , Adulto Jovem
4.
Arch Dis Child ; 104(11): 1102-1104, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-30389678

RESUMO

BACKGROUND: It is a public heath priority to understand why many children with mental health problems fail to access mental health services. This study aims to quantify under-recognition of children's mental health problems by parents across income quintiles. METHODS: We estimated under-recognition with parent-reported mental health problems and the Strengths and Difficulties Questionnaire (SDQ) using a nationally representative Australian data set for children aged 4-15 years with 24 269 person-wave observations. RESULTS: Under-recognition was the highest in the lowest income quintile, with 11.5% of children from the lowest income quintile families who scored in the clinical range on the SDQ perceived by parents as having no mental health problems. For the highest income quintile this was 2.4%. In terms of gender and age, under-recognition was greater for boys and younger children. CONCLUSIONS: Parent's mental health literacy, especially for low-income families, warrants prioritised attention from researchers, clinicians and policymakers.


Assuntos
Letramento em Saúde/estatística & dados numéricos , Transtornos Mentais/epidemiologia , Saúde Mental , Pais/educação , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Austrália/epidemiologia , Criança , Pré-Escolar , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Transtornos Mentais/diagnóstico , Avaliação das Necessidades , Relações Pais-Filho , Fatores Socioeconômicos
5.
Eur J Cardiothorac Surg ; 54(6): 1001-1003, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29757431

RESUMO

OBJECTIVES: We sought to determine the quality of life after the arterial switch operation (ASO) using the Short Form 36 questionnaire in adult survivors. METHODS: All patients (n = 107) who underwent the ASO and were 18 years of age or older living in the Australian state of Victoria with a contact telephone number were identified from the hospital database. Fifty-one (48%) patients were 18-24 years old and 56 (52%) patients were 25-34 years old. Patients completed the Short Form 36 quality of life questionnaire via telephone. The results of the 8 domains of the Short Form 36 questionnaire and the derived health state summary score (Short Form 6-Dimension) were compared against mean scores from age-matched Australian population data. RESULTS: Compared with the Australian population age-matched data, 18- to 24-year-old ASO patients ranked their health higher in 3 of the 8 domains (P < 0.01). The 25-34 age group ranked their health higher in 4 of the 8 domains (P < 0.01). No statistically significant differences in the mean Short Form 6-Dimension scores were observed in the 18-24 age group (0.769 for ASO patients vs 0.772 for Australian population, P = 0.85) or the 25-34 age group (0.795 for ASO patients vs 0.780 for Australian population, P = 0.33). CONCLUSIONS: Young adult survivors of the ASO have similar outcomes to age-matched controls in quality of life measured by Short Form 6-Dimension.


Assuntos
Transposição das Grandes Artérias , Qualidade de Vida , Transposição dos Grandes Vasos/cirurgia , Adolescente , Adulto , Transposição das Grandes Artérias/efeitos adversos , Transposição das Grandes Artérias/mortalidade , Transposição das Grandes Artérias/estatística & dados numéricos , Estudos de Coortes , Humanos , Inquéritos e Questionários , Vitória/epidemiologia , Adulto Jovem
6.
Soc Sci Med ; 208: 50-54, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29763786

RESUMO

Providing equitable care is an objective of many national healthcare systems. Using the birth cohort of the nationally representative Longitudinal Study of Australian Children linked with the Medicare Benefits Scheme billing data who were recruited in 2004 at ages 0-1 years and assessed biennially for six waves, we assessed the distribution of out-of-hospital government Medicare spending by household income. 4853 children followed over 11 years were included in the study. Distributions of major spending components including general practitioner and specialist care were assessed using concentration indices. Trends in the inequalities as children grow were investigated. The results showed that after controlling for health care needs, total government Medicare spending over 0-11 years of age favoured the rich (concentration index 0.041). The Medicare spending for general practitioner care was equal (concentration index 0.005) while for specialist care and diagnostics and imaging were 'pro-rich' (concentration index 0.108 and 0.088 respectively). Children from poorer families were most disadvantaged when aged 0-1 years in specialist spending, and the disparity lessened as children approached adolescence. Our findings suggest that income-related inequalities exist in government Medicare spending particularly in the first few years of life. As early years of life are a critical window in childhood development and building block for future health, the results warrant further investigation and attention from policy makers.


Assuntos
Governo , Gastos em Saúde/estatística & dados numéricos , Programas Nacionais de Saúde/economia , Austrália , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Fatores Socioeconômicos
7.
J Pediatr ; 196: 58-64.e2, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29550238

RESUMO

OBJECTIVE: To compare the cost-effectiveness of 2 common "noninvasive" modes of respiratory support for infants born preterm. STUDY DESIGN: An economic evaluation was conducted as a component of a multicenter, randomized control trial from 2013 to 2015 enrolling infants born preterm at ≥28 weeks of gestation with respiratory distress, <24 hours old, who had not previously received endotracheal intubation and mechanical ventilation or surfactant. The economic evaluation was conducted from a healthcare sector perspective and the time horizon was from birth until death or first discharge. The cost-effectiveness of continuous positive airway pressure (CPAP) vs high-flow with "rescue" CPAP backup and high-flow without rescue CPAP backup (as sole primary support) were analyzed by using the hospital cost of inpatient stay in a tertiary center and the rates of endotracheal intubation and mechanical ventilation during admission. RESULTS: Hospital inpatient cost records for 435 infants enrolled in all Australian centers were obtained. With "rescue" CPAP backup, an incremental cost-effectiveness ratio was estimated of A$179 000 (US$123 000) per ventilation avoided if CPAP was used compared with high flow. Without rescue CPAP backup, cost per ventilation avoided was A$7000 (US$4800) if CPAP was used compared with high flow. CONCLUSIONS: As sole primary support, CPAP is highly likely to be cost-effective compared with high flow. Neonatal units choosing to use only one device should apply CPAP as primary respiratory support. Compared with high-flow with rescue CPAP backup, CPAP is unlikely to be cost-effective if willingness to pay per ventilation avoided is less than A$179 000 (US$123 000).


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/economia , Ventilação com Pressão Positiva Intermitente/economia , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Administração Intranasal , Austrália , Análise Custo-Benefício , Feminino , Idade Gestacional , Custos de Cuidados de Saúde , Hospitalização , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Tempo de Internação , Masculino , Noruega , Surfactantes Pulmonares/uso terapêutico
8.
Am J Cardiol ; 120(3): 467-472, 2017 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-28583678

RESUMO

We estimated the inpatient resource use for a Fontan patient from birth to adulthood and explored factors that might induce cost differences (2014 US dollar). Inpatient costing records from 4 hospitals with greatest numbers of Fontan patients in Australia and New Zealand were linked with the Fontan registry database. Inpatient records between July 1995 and September 2014 for 420 Fontan patients were linked, and the most frequent primary diagnoses were hypoplastic left heart syndrome (20.7%), tricuspid atresia (19.7%), and double inlet left ventricle (17.1%). The mean hospital cost for a Fontan patient from birth to 18 years of age was estimated to be $390,601 (95% confidence interval [CI] $264,703 to $516,499), corresponding to 164 (95% CI 98 to 231) inpatient days. The cost incurred from birth through to Fontan completion (the staged procedures period) was $219,482 (95% CI $202,410 to $236,553) and the cost thereafter over 15 years was $146,820 (95% CI $44,409 to $249,231), corresponding to 82 (95% CI 72 to 92) and 65 (95% CI 18 to 112) inpatient days, respectively. Costs were higher in male and hypoplastic left heart syndrome patients in the staged procedures period (p <0.001). Having fenestration was associated with higher costs in the staged procedures period (p <0.001) and lower cost after Fontan over 15 years (p = 0.66). In conclusion, patients with single ventricle congenital heart disease continue to demand considerable inpatient resources after the staged procedures period. Over 40% of the pediatric hospital costs for Fontan patients were estimated to occur after the last planned surgery.


Assuntos
Técnica de Fontan/economia , Cardiopatias Congênitas/cirurgia , Ventrículos do Coração/anormalidades , Custos Hospitalares , Pacientes Internados , Sistema de Registros , Adolescente , Austrália/epidemiologia , Criança , Pré-Escolar , Feminino , Cardiopatias Congênitas/economia , Cardiopatias Congênitas/mortalidade , Ventrículos do Coração/cirurgia , Humanos , Lactente , Recém-Nascido , Masculino , Estudos Retrospectivos , Taxa de Sobrevida/tendências
9.
BMJ Open ; 7(6): e016746, 2017 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-28645982

RESUMO

INTRODUCTION: Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. METHODS AND ANALYSIS: The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are <24 hours old at randomisation and require non-invasive respiratory support or supplemental oxygen for >1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. ETHICS AND DISSEMINATION: Multisite ethical approval for the study has been granted by The Royal Children's Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results.


Assuntos
Recém-Nascido Prematuro , Oxigenoterapia/métodos , Oxigênio/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/mortalidade , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Acidose Respiratória/epidemiologia , Administração Intranasal , Pressão Positiva Contínua nas Vias Aéreas , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Masculino , New South Wales , Projetos de Pesquisa , Resultado do Tratamento , Vitória
10.
J Diabetes Complications ; 31(7): 1139-1144, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28462893

RESUMO

AIM: To determine the cost-effectiveness of gastric band surgery in overweight but not obese people who receive standard diabetes care. METHOD: A microsimulation model (United Kingdom Prospective Diabetes Study outcomes model) was used to project diabetes outcomes and costs from a two-year Australian randomized trial of gastric band (GB) surgery in overweight but not obese people (BMI 25 to 30kg/m2) on to a comparable population of U.S. adults from the National Health and Nutrition Examination Survey (N=254). Estimates of cost-effectiveness were calculated based on the incremental cost-effectiveness ratios (ICERs) for different treatment scenarios. Costs were inflated to 2015 U.S. dollar values and an ICER of less than $50,000 per QALY gained was considered cost-effective. RESULTS: The incremental cost-effectiveness ratio for GB surgery at two years exceeded $90,000 per quality-adjusted life year gained but decreased to $52,000, $29,000 and $22,000 when the health benefits of surgery were assumed to endure for 5, 10 and 15 years respectively. The cost-effectiveness of GB surgery was sensitive to utility gained from weight loss and, to a lesser degree, the costs of GB surgery. However, the cost-effectiveness of GB surgery was affected minimally by improvements in HbA1c, systolic blood pressure and cholesterol. CONCLUSIONS: GB surgery for overweight but not obese people with T2D appears to be cost-effective in the U.S. setting if weight loss endures for more than five years. Health utility gained from weight loss is a critical input to cost-effectiveness estimates and therefore should be routinely measured in populations undergoing bariatric surgery.


Assuntos
Cirurgia Bariátrica , Diabetes Mellitus Tipo 2/complicações , Modelos Econômicos , Sobrepeso/cirurgia , Austrália , Cirurgia Bariátrica/economia , Índice de Massa Corporal , Terapia Combinada/economia , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Custos e Análise de Custo , Diabetes Mellitus Tipo 2/economia , Diabetes Mellitus Tipo 2/terapia , Custos de Cuidados de Saúde , Humanos , Pessoa de Meia-Idade , Inquéritos Nutricionais , Sobrepeso/complicações , Sobrepeso/economia , Sobrepeso/terapia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos , Redução de Peso
11.
Int J Cardiol ; 240: 178-182, 2017 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-28456482

RESUMO

BACKGROUND: Patients undergoing palliative surgeries for single-ventricle conditions are affected by multiple comorbidities or non-cardiac conditions. The prevalence, costs and the cost implications of these conditions have not been assessed. METHODS: Administrative costing records from four hospitals in Australia and New Zealand were linked with the Fontan registry database to analyze the inpatient resource use for co-morbid or non-cardiac conditions. Inpatient costing records from the birth year through to Fontan completion were available for 156 patients. The most frequent primary diagnoses were hypoplastic left heart syndrome (33%), double inlet left ventricle (13%), and tricuspid atresia (12%). RESULTS: During the staged surgical treatment period, children had a mean of 10±6 inpatient admissions and spent 85±64days in hospital. Among these admissions, 3±5 were for non-cardiac conditions, totaling 21±41 inpatient days. Whilst cardiac surgeries were the major reason for resource use (77% of the total cost), other cardiac care that is not surgical contributed 5% and non-cardiac admissions 18% of the total cost. The three most prevalent non-cardiac diagnostic admission categories were 'Respiratory system', 'Digestive system', and 'Ear, nose, mouth and throat', affecting 28%, 21% and 34% of the patients respectively. Multivariate regression estimated that admissions for each of these categories resulted in an increased cost of $34,563 (P=0.08), $52,438 (P=0.05) and $10,525 (P=0.53) per patient respectively for the staged surgical treatment period. CONCLUSIONS: Non-cardiac admissions for single-ventricle patients are common and have substantial resource implications. Further research assessing the causes of admission and extent to which admissions are preventable is warranted.


Assuntos
Técnica de Fontan/economia , Custos Hospitalares , Hospitalização/economia , Síndrome do Coração Esquerdo Hipoplásico/economia , Atresia Tricúspide/economia , Austrália/epidemiologia , Criança , Pré-Escolar , Comorbidade , Bases de Dados Factuais/tendências , Feminino , Técnica de Fontan/tendências , Custos Hospitalares/tendências , Hospitalização/tendências , Humanos , Síndrome do Coração Esquerdo Hipoplásico/epidemiologia , Síndrome do Coração Esquerdo Hipoplásico/cirurgia , Masculino , Nova Zelândia/epidemiologia , Sistema de Registros , Atresia Tricúspide/epidemiologia , Atresia Tricúspide/cirurgia
12.
Aust Health Rev ; 41(4): 394-400, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27444270

RESUMO

Objective The aim of the present study was to quantify and understand the utilisation of linked hospital data for research purposes across Australia over the past two decades. Methods A systematic review was undertaken guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 checklist. Medline OVID, PsycINFO, Embase, EconLit and Scopus were searched to identify articles published from 1946 to December 2014. Information on publication year, state(s) involved, type of data linkage, disease area and purpose was extracted. Results The search identified 3314 articles, of which 606 were included; these generated 629 records of hospital data linkage use across all Australian states and territories. The major contributions were from Western Australia (WA; 51%) and New South Wales (NSW; 32%) with the remaining states and territories having significantly fewer publications (total contribution only 17%). WA's contribution resulted from a steady increase from the late 1990s, whereas NSW's contribution is mostly from a rapid increase from 2010. Current data linkage is primarily used in epidemiological research (73%). Conclusion More than 80% of publications were from WA and NSW, whereas other states significantly lag behind. The observable growth in these two states clearly demonstrates the underutilised opportunities for data linkage to add value in health services research in the other states. What is known about the topic? Linking administrative hospital data to other data has the potential to be a cost-effective method to significantly improve health policy. Over the past two decades, Australia has made significant investments in improving its data linkage capabilities. However, several articles have highlighted the many barriers involved in using linked hospital data. What does this paper add? This paper quantitatively evaluates the performance across all Australian states in terms of the use of their administrative hospital data for research purposes. The performance of states varies considerably, with WA and NSW the clear stand-out performers and limited outputs currently seen for the other Australian states and territories. What are the implications for practitioners? Given the significant investments made into data linkage, it is important to continue to evaluate and monitor the performance of the states in terms of translating this investment into outputs. Where the outputs do not match the investment, it is important to identify and overcome those barriers limiting the gains from this investment. More generally, there is a need to think about how we improve the effective and efficient use of data linkage investments in Australia.


Assuntos
Hospitais , Armazenamento e Recuperação da Informação , Registro Médico Coordenado , Web Semântica , Austrália , Bases de Dados Factuais , Administração Hospitalar , Registros Hospitalares , Humanos , Registro Médico Coordenado/métodos
13.
N Engl J Med ; 375(12): 1142-51, 2016 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-27653564

RESUMO

BACKGROUND: Treatment with nasal high-flow therapy has efficacy similar to that of nasal continuous positive airway pressure (CPAP) when used as postextubation support in neonates. The efficacy of high-flow therapy as the primary means of respiratory support for preterm infants with respiratory distress has not been proved. METHODS: In this international, multicenter, randomized, noninferiority trial, we assigned 564 preterm infants (gestational age, ≥28 weeks 0 days) with early respiratory distress who had not received surfactant replacement to treatment with either nasal high-flow therapy or nasal CPAP. The primary outcome was treatment failure within 72 hours after randomization. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the chosen margin of noninferiority was 10 percentage points. Infants in whom high-flow therapy failed could receive rescue CPAP; infants in whom CPAP failed were intubated and mechanically ventilated. RESULTS: Trial recruitment stopped early at the recommendation of the independent data and safety monitoring committee because of a significant difference in the primary outcome between treatment groups. Treatment failure occurred in 71 of 278 infants (25.5%) in the high-flow group and in 38 of 286 infants (13.3%) in the CPAP group (risk difference, 12.3 percentage points; 95% confidence interval [CI], 5.8 to 18.7; P<0.001). The rate of intubation within 72 hours did not differ significantly between the high-flow and CPAP groups (15.5% and 11.5%, respectively; risk difference, 3.9 percentage points; 95% CI, -1.7 to 9.6; P=0.17), nor did the rate of adverse events. CONCLUSIONS: When used as primary support for preterm infants with respiratory distress, high-flow therapy resulted in a significantly higher rate of treatment failure than did CPAP. (Funded by the National Health and Medical Research Council and others; Australian New Zealand Clinical Trials Registry number, ACTRN12613000303741 .).


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Ventilação não Invasiva , Oxigenoterapia/métodos , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Feminino , Idade Gestacional , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Surfactantes Pulmonares/uso terapêutico , Síndrome do Desconforto Respiratório do Recém-Nascido/mortalidade , Falha de Tratamento
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