Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 416
Filtrar
1.
Trials ; 22(1): 42, 2021 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-33430924

RESUMO

OBJECTIVES: As of December, 1st, 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, resulted in more than 1 472 917 deaths worldwide and death toll is still increasing exponentially. Many COVID-19 infected people are asymptomatic or experience moderate symptoms and recover without medical intervention. However, older people and those with comorbid hypertension, diabetes, obesity, or heart disease are at higher risk of mortality. Because current therapeutic options for COVID-19 patients are limited specifically for this elderly population at risk, Biophytis is developing BIO101 (20-hydroxyecdysone, a Mas receptor activator) as a new treatment option for managing patients with SARS-CoV-2 infection at the severe stage. The angiotensin converting enzyme 2 (ACE2) serves as a receptor for SARS-CoV-2. Interaction between ACE2 and SARS-CoV2 spike protein seems to alter the function of ACE2, a key player in the renin-angiotensin system (RAS). The clinical picture of COVID-19 includes acute respiratory distress syndrome (ARDS), cardiomyopathy, multiorgan dysfunction and shock, all of which might result from an imbalance of the RAS. We propose that RAS balance could be restored in COVID-19 patients through MasR activation downstream of ACE2 activity, with 20-hydroxyecdysone (BIO101) a non-peptidic Mas receptor (MasR) activator. Indeed, MasR activation by 20-hydroxyecdysone harbours anti-inflammatory, anti-thrombotic, and anti-fibrotic properties. BIO101, a 97% pharmaceutical grade 20-hydroxyecdysone could then offer a new therapeutic option by improving the respiratory function and ultimately promoting survival in COVID-19 patients that develop severe forms of this devastating disease. Therefore, the objective of this COVA study is to evaluate the safety and efficacy of BIO101, whose active principle is 20-hydroxyecdysone, in COVID-19 patients with severe pneumonia. TRIAL DESIGN: Randomized, double-blind, placebo-controlled, multi-centre, group sequential and adaptive which will be conducted in 2 parts. Part 1: Ascertain the safety and tolerability of BIO101 and obtain preliminary indication of the activity of BIO101, in preventing respiratory deterioration in the target population Part 2: Re-assessment of the sample size needed for the confirmatory part 2 and confirmation of the effect of BIO101 observed in part 1 in the target population. The study is designed as group sequential to allow an efficient run-through, from obtaining an early indication of activity to a final confirmation. And adaptive - to allow accumulation of early data and adapt sample size in part 2 in order to inform the final design of the confirmatory part of the trial. PARTICIPANTS: Inclusion criteria 1. Age: 45 and above 2. A confirmed diagnosis of COVID-19 infection, within the last 14 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used. 3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration ≥3 days 4. With evidence of pneumonia based on all of the following: a. Clinical findings on a physical examination b. Respiratory symptoms developed within the past 7 days 5. With evidence of respiratory decompensation that started not more than 4 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: a. Tachypnea: ≥25 breaths per minute b. Arterial oxygen saturation ≤92% c. A special note should be made if there is suspicion of COVID-19-related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. Without a significant deterioration in liver function tests: a. ALT and AST ≤ 5x upper limit of normal (ULN) b. Gamma-glutamyl transferase (GGT) ≤ 5x ULN c. Total bilirubin ≤ 5×ULN 7. Willing to participate and able to sign an informed consent form (ICF). Or, when relevant, a legally authorized representative (LAR) might sign the ICF on behalf of the study participant 8. Female participants should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; OR a. Have a negative urine pregnancy test at screening b. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of the investigational product. (Note: medically acceptable methods of contraception that may be used by the participant and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy). 10. Female participants who are lactating must agree not to breastfeed during the study and up to 14 days after the intervention. 11. Male participants must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of the investigational product. 12. For France only: Being affiliated with a European Social Security. Exclusion criteria 1. Not needing or not willing to remain in a healthcare facility during the study 2. Moribund condition (death likely in days) or not expected to survive for >7 days - due to other and non-COVID-19 related conditions 3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow Oxygen (delivery of oxygen at a flow of ≥16 L/min.). 4. Participant is not able to take medications by mouth (as capsules or as a powder, mixed in water). 5. Disallowed concomitant medication: Consumption of any herbal products containing 20-hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents). 6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101. 7. Renal disease requiring dialysis, or known renal insufficiency (eGFR≤30 mL/min/1.73 m2, based on Cockcroft & Gault formula). 8. In France only: a. Non-affiliation to compulsory French social security scheme (beneficiary or right-holder). b. Being under tutelage or legal guardianship. Participants will be recruited from approximately 30 clinical centres in Belgium, France, the UK, USA and Brazil. Maximum patients' participation in the study will last 28 days. Follow-up of participants discharged from hospital will be performed through post-intervention phone calls at 14 (± 2) and 60 (± 4) days. INTERVENTION AND COMPARATOR: Two treatment arms will be tested in this study: interventional arm 350 mg b.i.d. of BIO101 (AP 20-hydroxyecdysone) and placebo comparator arm 350 mg b.i.d of placebo. Administration of daily dose is the same throughout the whole treatment period. Participants will receive the study medication while hospitalized for up to 28 days or until a clinical endpoint is reached (i.e., 'negative' or 'positive' event). Participants who are officially discharged from hospital care will no longer receive study medication. MAIN OUTCOMES: Primary study endpoint: The proportion of participants with 'negative' events up to 28 days. 'Negative' events are defined as respiratory deterioration and all-cause mortality. For the purpose of this study, respiratory deterioration will be defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage). Requiring extracorporeal membrane oxygenation (ECMO). Requiring high-flow oxygen defined as delivery of oxygen at a flow of ≥16 L/min. Only if the primary endpoint is significant at the primary final analysis the following Key secondary endpoints will be tested in that order: Proportion of participants with events of respiratory failure at Day 28 Proportion of participants with 'positive' events at Day 28. Proportion of participants with events of all-cause mortality at Day 28 A 'positive' event is defined as the official discharge from hospital care by the department due to improvement in participant condition. Secondary and exploratory endpoints: In addition, a variety of functional measures and biomarkers (including the SpO2 / FiO2 ratio, viral load and markers related to inflammation, muscles, tissue and the RAS / MAS pathways) will also be collected. RANDOMIZATION: Randomization is performed using an IBM clinical development IWRS system during the baseline visit. Block-permuted randomization will be used to assign eligible participants in a 1:1 ratio. In part 1, randomization will be stratified by RAS pathway modulator use (yes/no) and co-morbidities (none vs. 1 and above). In Part 2, randomization will be stratified by centre, gender, RAS pathway modulator use (yes/no), co-morbidities (none vs. 1 and above), receiving Continuous Positive Airway Pressure/Bi-level Positive Airway Pressure (CPAP/BiPAP) at study entry (Yes/No) and suspicion of COVID-19 related myocarditis or pericarditis (present or not). BLINDING (MASKING): Participants, caregivers, and the study team assessing the outcomes are blinded to group assignment. All therapeutic units (TU), BIO101 b.i.d. or placebo b.i.d., cannot be distinguished in compliance with the double-blind process. An independent data-monitoring committee (DMC) will conduct 2 interim analyses. A first one based on the data from part 1 and a second from the data from parts 1 and 2. The first will inform about BIO101 safety, to allow the start of recruitment into part 2 followed by an analysis of the efficacydata, to obtain an indication of activity. The second interim analysis will inform about the sample size that will be required for part 2, in order to achieve adequate statistical power. Numbers to be randomised (sample size) Number of participants randomized: up to 465, in total Part 1: 50 (to obtain the proof of concept in COVID-19 patients). Part 2: 310, potentially increased by 50% (up to 465, based on interim analysis 2) (to confirm the effects of BIO101 observed in part 1). TRIAL STATUS: The current protocol Version is V 10.0, dated on 24.09.2020. The recruitment that started on September 1st 2020 is ongoing and is anticipated to finish for the whole study by March2021. TRIAL REGISTRATION: The trial was registered before trial start in trial registries: EudraCT , No. 2020-001498-63, registered May 18, 2020; and Clinicaltrials.gov, identifier NCT04472728 , registered July 15, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
/tratamento farmacológico , Ecdisterona/uso terapêutico , Insuficiência Respiratória/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , /fisiopatologia , Progressão da Doença , Método Duplo-Cego , Oxigenação por Membrana Extracorpórea/estatística & dados numéricos , Hospitalização , Humanos , Hipóxia/fisiopatologia , Pessoa de Meia-Idade , Mortalidade , Oxigenoterapia/estatística & dados numéricos , Proteínas Proto-Oncogênicas/metabolismo , Ensaios Clínicos Controlados Aleatórios como Assunto , Receptores Acoplados a Proteínas-G/metabolismo , Sistema Renina-Angiotensina , Respiração Artificial/estatística & dados numéricos , Insuficiência Respiratória/fisiopatologia , Glicoproteína da Espícula de Coronavírus/metabolismo , Taquipneia/fisiopatologia , Resultado do Tratamento
2.
Cochrane Database Syst Rev ; 1: CD013133, 2021 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-33448032

RESUMO

BACKGROUND: Symptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored. OBJECTIVES: To determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs. SELECTION CRITERIA: We included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants. DATA COLLECTION AND ANALYSIS: We used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding. MAIN RESULTS: We included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision. AUTHORS' CONCLUSIONS: High-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.


Assuntos
Inibidores de Ciclo-Oxigenase/uso terapêutico , Permeabilidade do Canal Arterial/tratamento farmacológico , Indometacina/uso terapêutico , Viés , Displasia Broncopulmonar/epidemiologia , Causas de Morte , Inibidores de Ciclo-Oxigenase/administração & dosagem , Inibidores de Ciclo-Oxigenase/efeitos adversos , Permeabilidade do Canal Arterial/mortalidade , Permeabilidade do Canal Arterial/cirurgia , Enterocolite Necrosante/induzido quimicamente , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Incidência , Indometacina/administração & dosagem , Indometacina/efeitos adversos , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Ligadura/estatística & dados numéricos , Oxigenoterapia/estatística & dados numéricos , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos
3.
Glob Health Sci Pract ; 8(4): 858-862, 2020 12 23.
Artigo em Inglês | MEDLINE | ID: mdl-33361248

RESUMO

Oxygen therapy is an essential medicine and core component of effective hospital systems. However, many hospitals in low- and middle-income countries lack reliable oxygen access-a deficiency highlighted and exacerbated by the coronavirus disease (COVID-19) pandemic. Oxygen access can be challenged by equipment that is low quality and poorly maintained, lack of clinical and technical training and protocols, and deficiencies in local infrastructure and policy environment. We share learnings from 2 decades of oxygen systems work with hospitals in Africa and the Asia-Pacific regions, highlighting practical actions that hospitals can take to immediately expand oxygen access. These include strategies to: (1) improve pulse oximetry and oxygen use, (2) support biomedical engineers to optimize existing oxygen supplies, and (3) expand on existing oxygen systems with robust equipment and smart design. We make all our resources freely available for use and local adaptation.


Assuntos
/epidemiologia , Países em Desenvolvimento , Oxigenoterapia/métodos , Oxigenoterapia/estatística & dados numéricos , Oxigênio/provisão & distribução , /terapia , Acesso aos Serviços de Saúde , Administração Hospitalar/estatística & dados numéricos , Humanos , Oximetria , Pandemias
4.
Medicine (Baltimore) ; 99(43): e22561, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-33120743

RESUMO

Although sedation for bronchoscopy improves patient comfort, there is a risk of oversedation in elderly patients. Only a few studies have evaluated the efficacy and safety of sedation for bronchoscopy in elderly patients.This study retrospectively analyzed records of 210 patients who underwent transbronchial brushing and/or biopsy under midazolam sedation at National Hospital Organization Omuta National Hospital between June 2017 and October 2019. Patients were administered 1 mg midazolam following 10 mL 4% lidocaine inhalation. When sedation was insufficient, 0.5 mg midazolam was administered additionally. Diagnostic yield, incidence of complications, amount of oxygen supplementation, decreases in percutaneous oxygen saturation (SpO2), changes in blood pressure, and degree of comfort were analyzed.Patients were divided into the elderly (n = 102) and non-elderly (n = 108) groups. No significant differences were observed in diagnostic yield and procedure time between the 2 groups, and no severe adverse events were noted in the elderly group. The degree of comfort during bronchoscopy was significantly higher in the elderly group. In patients administered < 2 mg midazolam, the amount of oxygen supplementation and decreases in SpO2 were significantly smaller in the elderly group compared to the non-elderly group.The risk of adverse events related to midazolam sedation in bronchoscopy does not increase with age, and sedation improves comfort during flexible bronchoscopy in elderly patients. Moreover, a total dose of midazolam <2 mg is safe for elderly patients undergoing bronchoscopy.


Assuntos
Broncoscopia , Sedação Consciente , Hipnóticos e Sedativos/uso terapêutico , Midazolam/uso terapêutico , Conforto do Paciente , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Oxigênio/sangue , Oxigenoterapia/estatística & dados numéricos , Estudos Retrospectivos
5.
Can Respir J ; 2020: 2045341, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33005276

RESUMO

Objective: Coronavirus disease 2019 (COVID-19), caused by the novel coronavirus SARS-CoV-2, was first identified in December 2019 in Wuhan, China, and has since spread globally, resulting in an ongoing pandemic. However, the study of asymptomatic patients is still rare, and the understanding of its potential transmission risk is still insufficient. In this study, epidemiological investigations were conducted in the Zhejiang province to understand the epidemiology and clinical characteristics of asymptomatic patients with COVID-19. Methods: This retrospective study was carried out on 22 asymptomatic patients and 234 symptomatic patients with COVID-19 who were hospitalized in Zhejiang Duodi Hospital from January 21 to March 16, 2020. The characteristics of epidemiology, demography, clinical manifestations, and laboratory data of mild patients were compared and analyzed. Results: The median age was 28 years in asymptomatic patients and 48 years in symptomatic patients. The proportion who were female was 77.3% in asymptomatic patients and 36.3% in symptomatic patients (p < 0.001). The proportion of patients with coexisting diseases was 4.5% in asymptomatic patients and 38.0% in symptomatic patients (p=0.002). The proportion of patients with increased CRP was 13.6% in the asymptomatic group and 61.1% in the symptomatic group (p < 0.001). The proportion of patients received antiviral therapy was 45.5% in the asymptomatic group and 97.9% in the symptomatic group (p < 0.001). The proportion of patients received oxygen therapy was 22.7% in the asymptomatic group and 99.1% in symptomatic patients (p < 0.001). By March 16, 2020, all patients were discharged from the hospital, and no symptoms had appeared in the asymptomatic patients during hospitalization. The median course of infection to discharge was 21.5 days in asymptomatic patients and 22 days in symptomatic patients. Conclusions: Asymptomatic patients are also infectious; relying only on clinical symptoms, blood cell tests, and radiology examination will lead to misdiagnosis of most patients, leading to the spread of the virus. Investigation of medical history is the best strategy for screening asymptomatic patients, especially young people, women, and people without coexisting disease, who are more likely to be asymptomatic when infected. Although the prognosis is good, isolation is critical for asymptomatic patients, and it is important not to end isolation early before a nucleic acid test turns negative.


Assuntos
Doenças Assintomáticas , Infecções por Coronavirus , Transmissão de Doença Infecciosa/prevenção & controle , Pandemias , Pneumonia Viral , Medição de Risco/métodos , Adulto , Fatores Etários , Doenças Assintomáticas/epidemiologia , Doenças Assintomáticas/terapia , Betacoronavirus/isolamento & purificação , China/epidemiologia , Comorbidade , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Erros de Diagnóstico/prevenção & controle , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/estatística & dados numéricos , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Prognóstico , Fatores Sexuais
6.
Pediatrics ; 146(5)2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33033176

RESUMO

OBJECTIVES: To describe the practice of high-flow nasal cannula (HFNC) use in the pediatric ward setting across North America. METHODS: A survey was distributed through the Pediatric Research in Inpatient Settings Network, which represents 114 hospital sites. Questions included indication for HFNC use, flow and oxygen parameters, guideline availability, and use of outcomes measures. RESULTS: There was a response rate of 68% to the survey from sites representing all regions from the United States. Thirty-seven sites (48%) used HFNC in the pediatric ward setting. All 37 sites used HFNC for patients with bronchiolitis. All children's hospital sites providing HFNC on the wards had an on-site ICU, compared with only 60% of non-children's hospital sites (P = .003). Seventy-six percent of sites used local protocols, including parameters for patient assessment, initiation, weaning, and feeding practices. CONCLUSIONS: HFNC is used outside the ICU in nearly 50% of responding hospitals, with variation related to flow rate, feeding, and protocol use. HFNC is used for management of acute respiratory distress due to bronchiolitis, asthma, and pneumonia. Study findings suggest that HFNC is often used by pediatric hospitalists, but its use across North American hospitals remains variable and based on local consensus.


Assuntos
Unidades Hospitalares/estatística & dados numéricos , Oxigenoterapia/estatística & dados numéricos , Pediatria/estatística & dados numéricos , Asma/terapia , Bronquiolite/terapia , Canadá , Cateterismo/métodos , Cateterismo/estatística & dados numéricos , Pesquisas sobre Serviços de Saúde/estatística & dados numéricos , Humanos , Oxigenoterapia/métodos , Pneumonia/terapia , Estados Unidos
8.
S Afr Med J ; 110(6): 484-490, 2020 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-32880559

RESUMO

BACKGROUND: Airway management is an essential skill for doctors working in the emergency department (ED). Safety and efficacy are crucial to its success. Analysis of an airway registry can provide feedback that can be used for quality improvement purposes. OBJECTIVES: To examine the first airway registry from an ED in South Africa (SA), a low- to middle-income country (LMIC), and compare the findings with international data. METHODS: A retrospective analysis of 13 months' data from the airway registry of an academic ED with an annual census of 60 000 patients. Data analysed included demographics, indications for intubation, intubator training level, type of intubation device, number of attempts, adverse events, pre-oxygenation methods, and drug and intravenous fluid use. RESULTS: A total of 321 intubations were included. The majority of the patients (71.6%) had non-traumatic indications for intubation. The overall first-pass intubation success (FPS) rate for doctors was 81.8%. Although this rate is lower than the mean rate suggested in an international meta-analysis (84.1%), it is within the 95% confidence interval (80.1 - 87.4%). Overall FPS rates showed no difference between video laryngoscopy (81.7%) compared with direct laryngoscopy (73.3%) (p-value 0.079), although better glottic views were obtained with video laryngoscopy (80.5% were Cormack-Lehane grade 1). Analysis of pre-oxygenation methods found that although sicker patients had received more aggressive pre-oxygenation, e.g. with non-invasive or bag-mask ventilation techniques, they still desaturated more often (35.8% and 62.5%, respectively) than less sick patients who received simple non-rebreather facemask pre-oxygenation (4.5%). CONCLUSIONS: This analysis of the first airway registry from an SA ED highlights that airway management in an LMIC can be performed on par with accepted international standards. It serves as a good baseline for further research into airway management in other LMICs and provides useful feedback for quality improvement purposes.


Assuntos
Manuseio das Vias Aéreas/métodos , Serviço Hospitalar de Emergência , Adulto , Idoso , Feminino , Hidratação/estatística & dados numéricos , Humanos , Intubação Intratraqueal/estatística & dados numéricos , Laringoscopia , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/estatística & dados numéricos , Sistema de Registros , Estudos Retrospectivos , África do Sul
10.
Am J Ther ; 27(5): e485-e490, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32804682

RESUMO

BACKGROUND: Coronavirus disease 2019 (COVID-19) has infected more than 4.4 million people and caused more than 300,000 deaths partly through acute respiratory distress syndrome with propensity to affect African American and Hispanic communities disproportionately. Patients with worse outcomes have exhibited higher blood plasma levels of proinflammatory cytokines. Activation of the vitamin D receptor expressed on immune cells has been shown to directly reduce the secretion of inflammatory cytokines, such as interleukin-6, and indirectly affect C-reactive protein. AREAS OF UNCERTAINTY: The significance of the vitamin D pathway in patients diagnosed with COVID-19. THERAPEUTIC INNOVATION: Vitamin D supplementation in patients after diagnosis of COVID-19. PATIENTS AND PHARMACOLOGICAL INTERVENTIONS: We report 4 vitamin D deficient patients diagnosed with COVID-19 in April 2020 who were provided with either cholecalciferol of 1000 IU daily (standard dose) or ergocalciferol 50,000 IU daily for 5 days (high dose) as part of supplementation. CLINICAL OUTCOMES: Patients that received a high dose of vitamin D supplementation achieved normalization of vitamin D levels and improved clinical recovery evidenced by shorter lengths of stay, lower oxygen requirements, and a reduction in inflammatory marker status. CONCLUSIONS: Vitamin D supplementation may serve as a viable alternative for curtailing acute respiratory distress syndrome in patients in underserved communities where resources to expensive and sought-after medications may be scarce. Randomized clinical trials will serve as an appropriate vessel to validate the efficacy of the therapeutic regimen and dissection of the pathway.


Assuntos
Betacoronavirus/isolamento & purificação , Colecalciferol/administração & dosagem , Infecções por Coronavirus , Ergocalciferóis/administração & dosagem , Pandemias , Pneumonia Viral , Deficiência de Vitamina D , Adulto , Proteína C-Reativa/análise , Comorbidade , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Suplementos Nutricionais , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/métodos , Oxigenoterapia/estatística & dados numéricos , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Receptores de Calcitriol/metabolismo , Resultado do Tratamento , Deficiência de Vitamina D/diagnóstico , Deficiência de Vitamina D/tratamento farmacológico , Deficiência de Vitamina D/epidemiologia , Deficiência de Vitamina D/metabolismo , Vitaminas/administração & dosagem
11.
Zhonghua Liu Xing Bing Xue Za Zhi ; 41(7): 1014-1020, 2020 Jul 10.
Artigo em Chinês | MEDLINE | ID: mdl-32741163

RESUMO

Objective: To understand the situation of respiratory rehabilitation and oxygen inhalation therapy in chronic obstructive pulmonary disease (COPD) patients aged 40 years or older in China, and provide basic information for the development of pulmonary rehabilitation. Methods: The data were from 2014-2015 COPD surveillance in China. Chinese residents aged 40 years or older were recruited through a complex multi-stage stratified cluster sampling from 125 COPD surveillance points in 31 provinces (autonomous regions, municipalities). Standardized face to face electronic questionnaires were used to collect information about respiratory rehabilitation and oxygen inhalation therapy of the patients. Spirometry was performed on all participants, and patients with post- bronchodilator FEV(1)/FVC<70% were diagnosed with COPD. The number of defined COPD patients was 9 134. Based on the complex sampling design, the respiratory rehabilitation treatment rate and oxygen inhalation therapy rate of COPD patients aged 40 years old or older in China were estimated, and the influencing factors were analyzed. Results: A total of 9 118 COPD patients aged 40 years or older were included in the analysis. The rate of respiratory rehabilitation was 0.8% (95CI: 0.6%-1.0%), and the rate of oxygen inhalation therapy was 2.5% (95%CI: 2.0%-2.9%). Among patients with severe symptoms or high risk of acute exacerbation (combined COPD assessment groups B, C, D), the rate of respiratory rehabilitation was 1.4% (95%CI: 0.9%-1.9%), and the rate of oxygen inhalation therapy was 5.4% (95%CI: 4.4%-6.4%). Multivariate logistic regression analysis showed that urban or rural residences, geographic area, awareness of COPD, history of acute exacerbation and severity of airflow restriction had influences on the respiratory rehabilitation rate in the COPD patients. Gender, geographic area, awareness of COPD, history of acute exacerbation, mMRC scores and severity of airflow restriction had influences on the patients' oxygen inhalation therapy rate. Conclusions: The rate of respiratory rehabilitation and oxygen inhalation therapy in COPD patients aged 40 years or older was relatively low in China. It is necessary to explore an effective model of pulmonary rehabilitation and COPD management, so that more COPD patients may have access to scientific pulmonary rehabilitation treatment.


Assuntos
Oxigenoterapia/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/reabilitação , Adulto , China/epidemiologia , Pesquisas sobre Serviços de Saúde , Humanos , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Espirometria
13.
Kidney Int ; 97(6): 1083-1088, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32354634

RESUMO

The outcome of SARS-CoV2 infection in patients who have received a kidney allograft and are being treated with immunosuppression is unclear. We describe 20 kidney transplant recipients (median age 59 years [inter quartile range 51-64 years], median age of transplant 13 years [9-20 years], baseline eGFR 36.5 [23-47.5]) with SARS-CoV2 induced pneumonia. At admission, all had immunosuppression withdrawn and were started on methylprednisolone 16 mg/day, all but one was commenced on antiviral therapy and hydroxychloroquine with doses adjusted for kidney function. At baseline, all patients presented fever but only one complained of difficulty in breathing. Half of patients showed chest radiographic evidence of bilateral infiltrates while the other half showed unilateral changes or no infiltrates. During a median follow-up of seven days, 87% experienced a radiological progression and among those 73% required escalation of oxygen therapy. Six patients developed acute kidney injury with one requiring hemodialysis. Six of 12 patients were treated with tocilizumab, a humanized monoclonal antibody to the IL-6 receptor. Overall, five kidney transplant recipients died after a median period of 15 days [15-19] from symptom onset. These preliminary findings describe a rapid clinical deterioration associated with chest radiographic deterioration and escalating oxygen requirement in renal transplant recipients with SARS-Cov2 pneumonia. Thus, in this limited cohort of long-term kidney transplant patients, SARS-CoV-2 induced pneumonia is characterized by high risk of progression and significant mortality.


Assuntos
Betacoronavirus/patogenicidade , Infecções por Coronavirus/mortalidade , Imunossupressores/efeitos adversos , Transplante de Rim/efeitos adversos , Pneumonia Viral/mortalidade , Anticorpos Monoclonais Humanizados/efeitos adversos , Betacoronavirus/imunologia , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Progressão da Doença , Feminino , Rejeição de Enxerto/imunologia , Rejeição de Enxerto/prevenção & controle , Humanos , Itália/epidemiologia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/instrumentação , Oxigenoterapia/estatística & dados numéricos , Pandemias , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Prognóstico , Transplantados/estatística & dados numéricos , Resultado do Tratamento
14.
Mayo Clin Proc ; 95(6): 1138-1147, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32376101

RESUMO

OBJECTIVE: To identify markers associated with in-hospital death in patients with coronavirus disease 2019 (COVID-19)-associated pneumonia. PATIENTS AND METHODS: A retrospective cohort study was conducted of 140 patients with moderate to critical COVID-19-associated pneumonia requiring oxygen supplementation admitted to the hospital from January 28, 2020, through February 28, 2020, and followed up through March 13, 2020, in Union Hospital, Wuhan, China. Oxygen saturation (SpO2) and other measures were tested as predictors of in-hospital mortality in survival analysis. RESULTS: Of 140 patients with COVID-19-associated pneumonia, 72 (51.4%) were men, with a median age of 60 years. Patients with SpO2 values of 90% or less were older and were more likely to be men, to have hypertension, and to present with dyspnea than those with SpO2 values greater than 90%. Overall, 36 patients (25.7%) died during hospitalization after median 14-day follow-up. Higher SpO2 levels after oxygen supplementation were associated with reduced mortality independently of age and sex (hazard ratio per 1-U SpO2, 0.93; 95% CI, 0.91 to 0.95; P<.001). The SpO2 cutoff value of 90.5% yielded 84.6% sensitivity and 97.2% specificity for prediction of survival. Dyspnea was also independently associated with death in multivariable analysis (hazard ratio, 2.60; 95% CI, 1.24 to 5.43; P=.01). CONCLUSION: In this cohort of patients with COVID-19, hypoxemia was independently associated with in-hospital mortality. These results may help guide the clinical management of patients with severe COVID-19, particularly in settings requiring strategic allocation of limited critical care resources. TRIAL REGISTRATION: Chictr.org.cn Identifier: ChiCTR2000030852.


Assuntos
Betacoronavirus/isolamento & purificação , Infecções por Coronavirus , Hipóxia , Oxigenoterapia , Pandemias , Pneumonia Viral , China , Infecções por Coronavirus/complicações , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/fisiopatologia , Feminino , Mortalidade Hospitalar , Humanos , Hipóxia/diagnóstico , Hipóxia/etiologia , Hipóxia/terapia , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Consumo de Oxigênio , Oxigenoterapia/métodos , Oxigenoterapia/estatística & dados numéricos , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Pneumonia Viral/diagnóstico , Pneumonia Viral/etiologia , Pneumonia Viral/mortalidade , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Prognóstico , Estudos Retrospectivos , Medição de Risco/métodos , Fatores de Risco , Índice de Gravidade de Doença
16.
Cochrane Database Syst Rev ; 4: CD013231, 2020 04 17.
Artigo em Inglês | MEDLINE | ID: mdl-32302428

RESUMO

BACKGROUND: Transient tachypnea of the newborn (TTN) is characterized by tachypnea and signs of respiratory distress. Transient tachypnea typically appears within the first two hours of life in term and late preterm newborns. Supportive management might be sufficient. Non-invasive (i.e. without endotracheal intubation) respiratory support may, however, be administered to reduce respiratory distress during TTN. In addition, non-invasive respiratory support might improve clearance of lung liquid thus reducing the effort required to breathe, improving respiratory distress and potentially reducing the duration of tachypnea. OBJECTIVES: To assess benefits and harms of non-invasive respiratory support for the management of transient tachypnea of the newborn. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 2), MEDLINE (1996 to 19 February 2019), Embase (1980 to 19 February 2019) and CINAHL (1982 to 19 February 2019). We applied no language restrictions. We searched clinical trial registries for ongoing studies. SELECTION CRITERIA: Randomized controlled trials, quasi-randomized controlled trials and cluster trials on non-invasive respiratory support provided to infants born at 34 weeks' gestational age or more and less than three days of age with transient tachypnea of the newborn. DATA COLLECTION AND ANALYSIS: For each of the included trials, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy, need for continuous positive airway pressure [CPAP] and need for mechanical ventilation, duration of mechanical ventilation, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review were need for mechanical ventilation and pneumothorax. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included three trials (150 infants) comparing either CPAP to free-flow oxygen, nasal intermittent mandatory ventilation to nasal CPAP, or nasal high-frequency percussive ventilation versus nasal CPAP. Due to these different comparisons and to high clinical heterogeneity in the baseline clinical characteristics, we did not pool the three studies. The use of CPAP versus free oxygen did not improve the primary outcomes of this review: need for mechanical ventilation (risk ratio [RR] 0.30, 95% confidence interval [CI] 0.01 to 6.99; 1 study, 64 participants); and pneumothorax (not estimable, no cases occurred). Among secondary outcomes, CPAP reduced the duration of tachypnea as compared to free oxygen (mean difference [MD] -21.10 hours, 95% CI -22.92 to -19.28; 1 study, 64 participants). Nasal intermittent ventilation did not reduce the need for mechanical ventilation as compared with CPAP (RR 4.00, 95% CI 0.49 to 32.72; 1 study, 40 participants) or the incidence of pneumothorax (RR 1.00, 95% CI 0.07 to 14.90; 1 study, 40 participants); duration of tachypnea did not differ (MD 4.30, 95% CI -19.14 to 27.74; 1 study, 40 participants). In the study comparing nasal high-frequency ventilation to CPAP, no cases of mechanical ventilation of pneumothorax occurred (not estimable; 1 study, 46 participants); duration of tachypnea was reduced in the nasal high-frequency ventilation group (MD -4.53, 95% CI -5.64 to -3.42; 1 study, 46 participants). The quality of the evidence was very low due to the imprecision of the estimates and unclear risk of bias for detection bias and high risk of bias for reporting bias. Tests for heterogeneity were not applicable for any of the analyses as no studies were pooled. Two trials are ongoing. AUTHORS' CONCLUSIONS: There is insufficient evidence to establish the benefit and harms of non-invasive respiratory support in the management of transient tachypnea of the newborn. Though two of the included trials showed a shorter duration of tachypnea, clinically relevant outcomes did not differ amongst the groups. Given the limited and low quality of the evidence available, it was impossible to determine whether non-invasive respiratory support was safe or effective for the treatment of transient tachypnea of the newborn.


Assuntos
Terapia Respiratória/métodos , Taquipneia Transitória do Recém-Nascido/terapia , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Pressão Positiva Contínua nas Vias Aéreas/estatística & dados numéricos , Ventilação de Alta Frequência/efeitos adversos , Ventilação de Alta Frequência/estatística & dados numéricos , Humanos , Recém-Nascido , Oxigenoterapia/efeitos adversos , Oxigenoterapia/estatística & dados numéricos , Pneumotórax/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial/estatística & dados numéricos , Terapia Respiratória/efeitos adversos , Fatores de Tempo , Taquipneia Transitória do Recém-Nascido/mortalidade
17.
Crit Care ; 24(1): 82, 2020 03 06.
Artigo em Inglês | MEDLINE | ID: mdl-32143664

RESUMO

BACKGROUND: Postextubation high-flow nasal cannula (HFNC) is used as a support therapy in high-risk patients in ICU. This study aimed to determine the effects of HFNC therapy on lung recruitment and overdistension assessed by electrical impedance tomography (EIT). METHODS: Twenty-four patients who received HFNC within 24 h after extubation were prospectively enrolled in this study. EIT was used to monitor regional lung ventilation distributions at baseline (conventional oxygen therapy) and three flow rate levels of HFNC therapy (20, 40, and 60 L/min). Change of end-expiratory lung impedance (ΔEELI), regional recruitment (recruited-pixels) and overdistension (overdistended-pixels), and lung strain change were determined by EIT. EIT images were equally divided into four ventral-to-dorsal horizontal regions of interest (ROIs 1, 2, 3, and 4). "Overdistension-by HFNC" due to HFNC is defined as an increase of overdistened-pixels > 10 than baseline. Patients were divided into two groups: (1) high potential of recruitment (HPR), recruited-pixels > 10 pixels at 60 L/min than baseline, and (2) low potential of recruitment (LPR), recruited-pixels < 10 pixels at 60 L/min than baseline. RESULTS: When the flow rate gradually increased from baseline to 60 L/min, a significant and consistent increasing trend of global ΔEELI (%) (p < 0.0001), recruited-pixels (p < 0.001), and overdistended-pixels (p = 0.101) was observed. Moreover, the increase of ΔEELI was mainly distributed in ROI2 (p = 0.001) and ROI3 (p < 0.0001). The HPR group (13/24 patients) had significantly higher recruited-pixels than the LPR group (11/24 patients) at 20, 40, and 60 L/min. There were no significant differences in PaO2/FiO2, ΔEELI (%), and overdistention pixels between the two groups. The HPR group had 13 patients in which no one had "overdistension-by HFNC", and the LPR group had 11 patients in which 4 patients had "overdistension-by HFNC" (0/13 vs. 4/11, p = 0.017). CONCLUSIONS: Using EIT could identify diverse effects of HFNC on lung regional ventilation in postextubation situations. Further study is required to validate using "HFNC effect" based on lung recruitment and overdistension by EIT in clinical practice. TRIAL REGISTRATION: The study was retrospectively registered at www.clinicaltrials.gov (no. NCT04245241).


Assuntos
Extubação/instrumentação , Cânula/normas , Oxigenoterapia/normas , Oxigênio/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Extubação/métodos , Extubação/estatística & dados numéricos , Gasometria/métodos , Cânula/estatística & dados numéricos , Estado Terminal/terapia , Feminino , Humanos , Intubação Intratraqueal/métodos , Masculino , Pessoa de Meia-Idade , Ventilação não Invasiva/métodos , Ventilação não Invasiva/normas , Ventilação não Invasiva/estatística & dados numéricos , Oxigênio/uso terapêutico , Oxigenoterapia/métodos , Oxigenoterapia/estatística & dados numéricos
18.
Isr Med Assoc J ; 22(3): 173-177, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32147983

RESUMO

BACKGROUND: The use of a high flow nasal cannula (HFNC) was examined for different clinical indications in the critically ill. OBJECTIVES: To describe a single center experience with HFNC in post-extubation critical care patients by using clinical indices. METHODS: In this single center study, the authors retrospectively evaluated the outcome of patients who were connected to the HFNC after their extubation in the intensive care unit (ICU). At 48 hours after the extubation, the patients were divided into three groups: the group weaned from HFNC, the ongoing HFNC group, and the already intubated group. RESULTS: Of the 80 patients who were included, 42 patients were without HFNC support at 48 hours after extubation, 22 and 16 patients were with ongoing HFNC support and already intubated by this time frame, respectively. The mean ROX index (the ratio of SpO2 divided by fraction of inspired oxygen to respiratory rate) at 6 hours of the weaned group was 12.3 versus 9.3 in the ongoing HFNC group, and 8.5 in the reintubated group (P = 0.02). The groups were significantly different by the ICU length of stay, tracheostomy rate, and mortality. CONCLUSIONS: Among patients treated with HFNC post-extubation of those who had a higher ROX index were less likely to undergo reintubation.


Assuntos
Extubação , Cuidados Críticos/métodos , Oxigenoterapia/métodos , Oxigenoterapia/estatística & dados numéricos , Insuficiência Respiratória/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Cânula , Estado Terminal , Feminino , Humanos , Unidades de Terapia Intensiva , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/instrumentação , Estudos Retrospectivos , Tempo , Adulto Jovem
19.
Pediatr Pulmonol ; 55 Suppl 1: S65-S77, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32130796

RESUMO

INTRODUCTION: Hypoxemia is a life-threatening condition and is commonly seen in children with severe pneumonia. A government-led, NGO-supported, multifaceted oxygen improvement program was implemented to increase access to oxygen therapy in 29 hospitals in Kaduna, Kano, and Niger states. The program installed pulse oximeters and oxygen concentrators, trained health care workers, and biomedical engineers (BMEs), and provided regular feedback to health care staff through quality improvement teams. OBJECTIVE: The aim of this study is to evaluate whether the program increased screening for hypoxemia with pulse oximetry and prescription of oxygen for patients with hypoxemia. METHODOLOGY: The study is an uncontrolled before-after interventional study implemented at the hospital level. Medical charts of patients under 5 admitted for pneumonia between January 2017 and August 2018 were reviewed and information on patient care was extracted using a standardized form. The preintervention period of this study was defined as 1 January to 31 October 2017 and the postintervention period as 1 February to 31 August 2018. The primary outcomes of the study were whether blood-oxygen saturation measurements (SpO2 ) were documented and whether children with hypoxemia were prescribed oxygen. RESULTS: A total of 3418 patient charts were reviewed (1601 during the preintervention period and 1817 during the postintervention period). There was a significant increase in the proportion of patients with SpO2 measurements after the interventions were conducted (adjusted odds ratio [aOR] 5.0; 4.3-5.7, P < .001). Before the interventions, only 13.7% (95% confidence interval [CI]: 12.2-15.3) of patients had SpO2 measurements and after the interventions, 82.4% (95% CI: 80.7-84.1) had SpO2 measurements. Oxygen administration for patients with clinical signs of hypoxemia also increased significantly (aOR 5.0; 4.2-5.9, P < .001)-from 22.8% (95% CI: 18.8-27.2) to 77.9% (95% CI: 73.9-81.5). CONCLUSION: Increasing pulse oximetry and oxygen therapy access and utilization in a low-resourced environment is achievable through a multifaceted program focused on strengthening government-owned systems.


Assuntos
Oxigenoterapia/estatística & dados numéricos , Criança , Pré-Escolar , Feminino , Pessoal de Saúde , Hospitalização , Hospitais , Humanos , Hipóxia/diagnóstico , Lactente , Masculino , Nigéria , Razão de Chances , Oximetria , Oxigênio , Pneumonia/diagnóstico
20.
Trials ; 21(1): 125, 2020 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-32005282

RESUMO

BACKGROUND: Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. However, effective therapies for this disease are lacking. Stem-cell therapy is a promising way to improve lung injury and abnormal alveolarization, and the human umbilical cord (hUC) is a good source of mesenchymal stem cells (MSCs), which have demonstrated efficacy in other diseases. We hypothesized that intravenously administered allogeneic hUC-MSCs are safe and effective for severe BPD. METHODS: The MSC-BPD trial is a randomized, single-center, open-label, dose-escalation, phase-II trial designed to investigate the safety and efficacy of hUC-MSCs in children with severe BPD. In this study, 72 patients will be enrolled and randomly divided into two intervention groups and one control group. Patients in the intervention groups will receive a low dose of hUC-MSCs (n = 24; 2.5 million cells/kg) or a high dose of hUC-MSCs (n = 24; 5 million cells/kg) in combination with traditional supportive treatments for BPD. The patients in the control group (n = 24) will be treated with traditional supportive treatments alone without hUC-MSCs. The primary outcome measures will be cumulative duration of oxygen therapy. Follow-up assessments will be performed at 1, 3, 6, 12, and 24 months post intervention, and the key outcome during follow-up will be changes on chest radiography. Statistical analyses will evaluate the efficacy of the hUC-MSC treatment. DISCUSSION: This will be the first randomized controlled trial to evaluate the safety and efficacy of intravenously administered hUC-MSCs in children with severe BPD. Its results should provide a new evidence-based therapy for severe BPD. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03601416. Registered on 26 July 2018.


Assuntos
Displasia Broncopulmonar/terapia , Transplante de Células-Tronco de Sangue do Cordão Umbilical/métodos , Pulmão , Células-Tronco Mesenquimais/fisiologia , Administração Intravenosa , Displasia Broncopulmonar/diagnóstico , Displasia Broncopulmonar/fisiopatologia , Ensaios Clínicos Fase II como Assunto , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro/fisiologia , Pulmão/diagnóstico por imagem , Pulmão/fisiopatologia , Masculino , Avaliação de Resultados em Cuidados de Saúde/métodos , Oxigenoterapia/estatística & dados numéricos , Radiografia Torácica/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA