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2.
Ugeskr Laeger ; 186(14)2024 Apr 01.
Artigo em Dinamarquês | MEDLINE | ID: mdl-38606702

RESUMO

In the last 30 years, the treatment of obstructive lung diseases, such as asthma and COPD, has seen significant advancements. Introduction of inhaled corticosteroids (ICS) and, more recently, biological treatments has revolutionized care. Biological treatments are very successful in severe asthma and are expected to be approved for COPD soon. Systematic assessment and multidimensional treatment approaches are crucial in both conditions. Future care may involve specialized centres for severe obstructive lung diseases, focusing on personalized approaches and monitoring, as argued in this review.


Assuntos
Asma , Doença Pulmonar Obstrutiva Crônica , Humanos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Asma/tratamento farmacológico , Corticosteroides/uso terapêutico
3.
Ugeskr Laeger ; 186(14)2024 Apr 01.
Artigo em Dinamarquês | MEDLINE | ID: mdl-38606704

RESUMO

In this review, we discuss a new definition and treatment options of allergic alveolitis (AA). AA is an immune-mediated interstitial lung disease triggered by inhaled antigens, it is defined as non-fibrotic (inflammatory) and/or fibrotic, and diagnosis relies on a multidisciplinary approach using clinical, radiological and sometimes histological assessments. Treatment involves early antigen elimination and may include corticosteroids or other immunosuppressants. Prognosis varies from reversible inflammation to irreversible fibrosis. Early detection is crucial for better outcomes.


Assuntos
Alveolite Alérgica Extrínseca , Doenças Pulmonares Intersticiais , Humanos , Doenças Pulmonares Intersticiais/terapia , Doenças Pulmonares Intersticiais/tratamento farmacológico , Prognóstico , Corticosteroides/uso terapêutico , Imunossupressores/uso terapêutico , Pulmão/patologia
4.
Ugeskr Laeger ; 186(14)2024 Apr 01.
Artigo em Dinamarquês | MEDLINE | ID: mdl-38606705

RESUMO

This review highlights key aspects of treating chronic obstructive pulmonary disease (COPD) exacerbation, focusing on the optimisation of systemic corticosteroid and antibiotic use through personalised treatment using biomarkers. Eosinophil-guided therapy reduces corticosteroid usage which might reduce side effects, while procalcitonin-guided therapy contributes to reduced antibiotic consumption. These approaches, documented through well-conducted randomized controlled trials, suggest the possibility of enhancing COPD exacerbation management, reducing potential side effects, and addressing concerns related to antibiotic resistance.


Assuntos
Doença Pulmonar Obstrutiva Crônica , Humanos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Antibacterianos/uso terapêutico , Glucocorticoides/uso terapêutico , Corticosteroides/uso terapêutico , Progressão da Doença , Biomarcadores
5.
PLoS Med ; 21(4): e1004378, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38557442

RESUMO

BACKGROUND: Antenatal corticosteroids for women at risk of preterm birth reduce neonatal morbidity and mortality, but there is limited evidence regarding their effects on long-term health. This study assessed cardiovascular outcomes at 50 years after antenatal exposure to corticosteroids. METHODS AND FINDINGS: We assessed the adult offspring of women who participated in the first randomised, double-blind, placebo-controlled trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome (RDS) (1969 to 1974). The first 717 mothers received 2 intramuscular injections of 12 mg betamethasone or placebo 24 h apart and the subsequent 398 received 2 injections of 24 mg betamethasone or equivalent volume of placebo. Follow-up included a health questionnaire and consent to access administrative data sources. The co-primary outcomes were the prevalence of cardiovascular risk factors (any of hypertension, hyperlipidaemia, diabetes mellitus, gestational diabetes mellitus, or prediabetes) and age at first major adverse cardiovascular event (MACE) (cardiovascular death, myocardial infarction, coronary revascularisation, stroke, admission for peripheral vascular disease, and admission for heart failure). Analyses were adjusted for gestational age at entry, sex, and clustering. Of 1,218 infants born to 1,115 mothers, we followed up 424 (46% of survivors; 212 [50%] female) at mean (standard deviation) age 49.3 (1.0) years. There were no differences between those exposed to betamethasone or placebo for cardiovascular risk factors (159/229 [69.4%] versus 131/195 [67.2%]; adjusted relative risk 1.02, 95% confidence interval [CI] [0.89, 1.18;]; p = 0.735) or age at first MACE (adjusted hazard ratio 0.58, 95% CI [0.23, 1.49]; p = 0.261). There were also no differences in the components of these composite outcomes or in any of the other secondary outcomes. Key limitations were follow-up rate and lack of in-person assessments. CONCLUSIONS: There is no evidence that antenatal corticosteroids increase the prevalence of cardiovascular risk factors or incidence of cardiovascular events up to 50 years of age. Established benefits of antenatal corticosteroids are not outweighed by an increase in adult cardiovascular disease.


Assuntos
Nascimento Prematuro , Síndrome do Desconforto Respiratório do Recém-Nascido , Lactente , Adulto , Feminino , Recém-Nascido , Humanos , Gravidez , Pessoa de Meia-Idade , Masculino , Betametasona/efeitos adversos , Seguimentos , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/prevenção & controle , Nascimento Prematuro/tratamento farmacológico , Corticosteroides , Pulmão , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Síndrome do Desconforto Respiratório do Recém-Nascido/prevenção & controle
6.
Ann Intern Med ; 177(4): JC43, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38560905

RESUMO

SOURCE CITATION: Jackson DJ, Heaney LG, Humbert M, et al; SHAMAL Investigators. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study. Lancet. 2024;403:271-281. 38071986.


Assuntos
Antiasmáticos , Asma , Humanos , Antiasmáticos/uso terapêutico , Progressão da Doença , Asma/tratamento farmacológico , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/efeitos adversos , Corticosteroides/uso terapêutico
7.
Br J Hosp Med (Lond) ; 85(3): 1-12, 2024 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-38557089

RESUMO

Haemophagocytic lymphohistiocytosis is a severe systemic hyperinflammatory syndrome characterised by dysregulation of immune cells and excessive production of cytokines, also known as a cytokine storm. It has distinctive clinical features with fever, hyperferritinaemia and falling blood counts. In adults, this usually occurs secondary to an underlying driver or trigger including infection, malignancy or rheumatic diseases. Prompt treatment with immunomodulatory therapy, including corticosteroids and the recombinant IL-1 receptor antagonist anakinra, is recommended to switch off the cytokine storm. Etoposide-based regimens are sometimes needed, and newer therapies such as emapalumab and JAK inhibitors are increasingly being used. The incidence of haemophagocytic lymphohistiocytosis has increased significantly over the last 20 years which may partly reflect increased awareness of the condition. Although relatively rare, haemophagocytic lymphohistiocytosis can be encountered by a broad range of hospital physicians, so knowing how to diagnose and treat this condition is essential. This article reviews the pathogenesis, clinical features, causes, diagnosis and treatment of haemophagocytic lymphohistiocytosis to improve physician recognition and management of this condition to improve future patient outcomes.


Assuntos
Linfo-Histiocitose Hemofagocítica , Neoplasias , Adulto , Humanos , Linfo-Histiocitose Hemofagocítica/diagnóstico , Linfo-Histiocitose Hemofagocítica/tratamento farmacológico , Linfo-Histiocitose Hemofagocítica/etiologia , Síndrome da Liberação de Citocina , Neoplasias/complicações , Corticosteroides , Diagnóstico Diferencial
8.
Cleve Clin J Med ; 91(4): 203-204, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38561207
10.
Ideggyogy Sz ; 77(3-4): 121-129, 2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38591925

RESUMO

Background and purpose:

We aimed to investigate the difference of clinical and electrophysiological improvement between perineural corticosteroid injection therapy (PCIT) and perineural 5% dextrose injection therapy (5%PDIT) in carpal tunnel syndrome (CTS).

. Methods:

Total of 92 wrists that were diagnosed as mild-to-moderate idiopathic CTS and completed their follow-up were included in our study. The severity of pain, symptom severity and functional status were asses­sed by visual analog scale (VAS) and the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) scores for treatment effectiveness. Randomized wrists were administered PCIT or 5%PDIT accompanied by ultrasound guidance. VAS, BCTQ scores and the electro­physiological study repeated before and after treatment at the 1st and 6th months after perineural injection therapies (PITs) were recorded.

. Results:

Compared with baseline data, within groups there was significant improvement in VAS, BCTQ severity and function scores at 1st and 6th months follow-up (all p < 0.001). Considerable advance were detected in the median sensory nerve conduction velocity (SNCV) when pretreatment values were compared with posttreatment first month in both groups (p = 0.01; p < 0.001, respectively). No significant change occurred in median distal motor latency (DML) values between the 1st and 6th months in the groups (p = 0.095; p = 0.113, respectively). No significant difference was observed bet­ween 5%PDIT and PCIT groups.

. Conclusion:

Clinical and electrophysiologic improvement in CTS began from 1st month after PCIT and 5%PDIT. At the 6th month follow-up of the patients, 5%PDIT and PCIT had similar therapeutic effects. As a result, we can consider the replacement of PCIT with 5%PDIT in mild-to-moderate CTS patients especially in those who are hesitant because of the corticosteroid’s adverse effects.

.


Assuntos
Síndrome do Túnel Carpal , Humanos , Síndrome do Túnel Carpal/tratamento farmacológico , Punho , Corticosteroides/uso terapêutico , Resultado do Tratamento , Glucose
13.
Gen Comp Endocrinol ; 352: 114514, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38582175

RESUMO

Hormonal influence on hepatic function is a critical aspect of whole-body energy balance in vertebrates. Catecholamines and corticosteroids both influence hepatic energy balance via metabolite mobilization through glycogenolysis and gluconeogenesis. Elasmobranchs have a metabolic organization that appears to prioritize the mobilization of hepatic lipid as ketone bodies (e.g. 3-hydroxybutyrate [3-HB]), which adds complexity in determining the hormonal impact on hepatic energy balance in this taxon. Here, a liver perfusion was used to investigate catecholamine (epinephrine [E]) and corticosteroid (corticosterone [B] and 11-deoxycorticosterone [DOC]) effects on the regulation of hepatic glucose and 3-HB balance in the North Pacific Spiny dogfish, Squalus suckleyi. Further, hepatic enzyme activity involved in ketogenesis (3-hydroxybutyrate dehydrogenase), glycogenolysis (glycogen phosphorylase), and gluconeogenesis (phosphoenolpyruvate carboxykinase) were assessed in perfused liver tissue following hormonal application to discern effects on hepatic energy flux. mRNA transcript abundance key transporters of glucose (glut1 and glut4) and ketones (mct1 and mct2) and glucocorticoid function (gr, pepck, fkbp5, and 11ßhsd2) were also measured to investigate putative cellular components involved in hepatic responses. There were no changes in the arterial-venous difference of either metabolite in all hormone perfusions. However, perfusion with DOC increased gr transcript abundance and decreased flow rate of perfusions, suggesting a regulatory role for this corticosteroid. Phosphoenolpyruvate carboxykinase activity increased following all hormone treatments, which may suggest gluconeogenic function; E also increased 3-hydroxybutyrate dehydrogenase activity, suggesting a function in ketogenesis, and decreased pepck and fkbp5 transcript abundance, potentially showing some metabolic regulation. Overall, we demonstrate hormonal control of hepatic energy balance using liver perfusions at various levels of biological organization in an elasmobranch.


Assuntos
Squalus acanthias , Squalus , Animais , Glucose/metabolismo , Squalus/metabolismo , Squalus acanthias/metabolismo , Hidroxibutirato Desidrogenase/metabolismo , Fosfoenolpiruvato/metabolismo , Fígado/metabolismo , Ácido 3-Hidroxibutírico/farmacologia , Ácido 3-Hidroxibutírico/metabolismo , Corpos Cetônicos/metabolismo , Gluconeogênese , Hormônios/metabolismo , Corticosteroides/metabolismo
14.
Respir Investig ; 62(3): 503-511, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38599052

RESUMO

BACKGROUND: For the treatment of COPD exacerbations, systemic corticosteroids are recommended in addition to short-acting bronchodilators. Although there have been several systemic reviews, many of the included studies were conducted before 2007 and a re-evaluation has not been performed since 2014. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety profile of systemic corticosteroids in patients with COPD during exacerbations. METHODS: We searched relevant randomized control trials (RCTs) and analyzed the treatment failure, relapse, lung function, improvement in PaO2 and PaCO2, dyspnea, quality of life (QOL), length of stay in hospital and adverse events including hyperglycemia and mortality as the outcomes of interest. RESULTS: We identified a total of 12 RCTs (N = 1336). Systemic corticosteroids significantly reduced the treatment failure (odds ratios; OR 0.41, 95% confidence intervals; CI 0.25 to 0.67) and hospital length of stay (mean difference; MD -1.57 days, 95% CI -2.36 to -0.78) and improved FEV1 (MD 0.18 L, 95% CI 0.08 to 0.28) and dyspnea (transitional dyspnea index; MD 1.90, 95% CI 0.26 to 3.54) in COPD exacerbations compared to placebo. However, systemic corticosteroids were associated with a significantly higher incidence of adverse events (OR 1.83, 95% CI 1.25 to 2.69) and hyperglycemia (OR 2.94, 95% CI 1.68 to 5.14). CONCLUSIONS: In patients with moderate and severe COPD and severe obstructive impairment during exacerbations, systemic corticosteroids cause more adverse events, including hyperglycemia, than placebo but significantly reduce the treatment failure and hospital length of stay and improve FEV1 and dyspnea.


Assuntos
Hiperglicemia , Doença Pulmonar Obstrutiva Crônica , Humanos , Progressão da Doença , Corticosteroides/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Dispneia/induzido quimicamente , Hiperglicemia/tratamento farmacológico , Qualidade de Vida
15.
Ren Fail ; 46(1): 2341787, 2024 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38637275

RESUMO

BACKGROUND: Immunoglobulin A (IgA) nephropathy (IgAN) treatment consists of maximal supportive care and, for high-risk individuals, immunosuppressive treatment (IST). There are conflicting results regarding IST. Therefore, we aimed to investigate IST results among IgAN patients in Turkiye. METHOD: The data of 1656 IgAN patients in the Primary Glomerular Diseases Study of the Turkish Society of Nephrology Glomerular Diseases Study Group were analyzed. A total of 408 primary IgAN patients treated with IST (65.4% male, mean age 38.4 ± 12.5 years, follow-up 30 (3-218) months) were included and divided into two groups according to treatment protocols (isolated corticosteroid [CS] 70.6% and combined IST 29.4%). Treatment responses, associated factors were analyzed. RESULTS: Remission (66.7% partial, 33.7% complete) was achieved in 74.7% of patients. Baseline systolic blood pressure, mean arterial pressure, and proteinuria levels were lower in responsives. Remission was achieved at significantly higher rates in the CS group (78% vs. 66.7%, p = 0.016). Partial remission was the prominent remission type. The remission rate was significantly higher among patients with segmental sclerosis compared to those without (60.4% vs. 49%, p = 0.047). In the multivariate analysis, MEST-C S1 (HR 1.43, 95% CI 1.08-1.89, p = 0.013), MEST-C T1 (HR 0.68, 95% CI 0.51-0.91, p = 0.008) and combined IST (HR 0.66, 95% CI 0.49-0.91, p = 0.009) were found to be significant regarding remission. CONCLUSION: CS can significantly improve remission in high-risk Turkish IgAN patients, despite the reliance on non-quantitative endpoints for favorable renal outcomes. Key predictors of remission include baseline proteinuria and specific histological markers. It is crucial to carefully weigh the risks and benefits of immunosuppressive therapy for these patients.


Assuntos
Glomerulonefrite por IGA , Falência Renal Crônica , Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Feminino , Glomerulonefrite por IGA/tratamento farmacológico , Glomerulonefrite por IGA/patologia , Turquia , Falência Renal Crônica/terapia , Imunossupressores/uso terapêutico , Corticosteroides , Proteinúria/etiologia , Proteinúria/induzido quimicamente , Estudos Retrospectivos , Taxa de Filtração Glomerular
16.
BMC Pregnancy Childbirth ; 24(1): 286, 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38637735

RESUMO

BACKGROUND: To investigate the association between late preterm antenatal corticosteroid treatment and outcome in late preterm neonates born to mothers with gestational diabetes mellitus, METHODS: All patients with gestational diabetes mellitus who had a late preterm delivery at Etlik Lady Zübeyde Hospital between 2017 and 2021 were included. Women who met the inclusion criteria and were not given antenatal corticosteroid treatment during current pregnancy before 34 0/7 weeks of gestation were divided into two groups according to whether or not they received late preterm antenatal corticosteroid treatment. The two groups were compared in terms of adverse neonatal complications. The main outcomes were composite respiratory outcome and composite neonatal outcome. Logistic regression analysis was used to determine additional potential predictors of neonatal outcome. RESULTS: This retrospective cohort study included a total of 400 participants with gestational diabetes mellitus who had a late preterm delivery within the study period. Of these women, 196 (49%) received late preterm antenatal corticosteroid treatment. Main outcomes showed no difference. Decreasing gestational age at birth was identified as an independent risk factor predicting both composite respiratory outcome and composite neonatal outcome in multivariate logistic regression analysis. CONCLUSIONS: Antenatal corticosteroid treatment at or after 34 0/7 weeks of gestation in women with gestational diabetes mellitus who had a late preterm delivery was not associated with improvement in adverse neonatal outcomes. Decreasing gestational age at birth was the only independent risk factor predicting composite neonatal and composite respiratory outcomes.


Assuntos
Diabetes Gestacional , Nascimento Prematuro , Síndrome do Desconforto Respiratório do Recém-Nascido , Recém-Nascido , Humanos , Gravidez , Feminino , Diabetes Gestacional/tratamento farmacológico , Diabetes Gestacional/epidemiologia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/induzido quimicamente , Estudos Retrospectivos , Corticosteroides/uso terapêutico , Idade Gestacional , Síndrome do Desconforto Respiratório do Recém-Nascido/epidemiologia , Síndrome do Desconforto Respiratório do Recém-Nascido/prevenção & controle
17.
Ital J Pediatr ; 50(1): 74, 2024 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-38637856

RESUMO

BACKGROUND: Plastic bronchitis (PB) can occur in patients who have undergone congenital heart surgery (CHS). This study aimed to investigate the clinical features of PB in children after CHS. METHODS: We conducted a retrospective cohort study using the electronic medical record system. The study population consisted of children diagnosed with PB after bronchoscopy in the cardiac intensive care unit after CHS from May 2016 to October 2021. RESULTS: A total of 68 children after CHS were finally included in the study (32 in the airway abnormalities group and 36 in the right ventricular dysfunction group). All children were examined and treated with fiberoptic bronchoscopy. Pathogens were detected in the bronchoalveolar lavage fluid of 41 children, including 32 cases in the airway abnormalities group and 9 cases in the right ventricular dysfunction group. All patients were treated with antibiotics, corticosteroids (intravenous or oral), and budesonide inhalation suspension. Children with right ventricular dysfunction underwent pharmacological treatment such as reducing pulmonary arterial pressure. Clinical symptoms improved in 64 children, two of whom were treated with veno-arterial extracorporeal membrane oxygenation (ECMO) due to recurrent PB and disease progression. CONCLUSIONS: Children with airway abnormalities or right ventricular dysfunction after CHS should be alerted to the development of PB. Pharmacological treatment such as anti-infection, corticosteroids, or improvement of right ventricular function is the basis of PB treatment, while fiberoptic bronchoscopy is an essential tool for the diagnosis and treatment of PB. ECMO assistance is a vital salvage treatment for recurrent critically ill PB patients.


Assuntos
Bronquite , Cardiopatias Congênitas , Disfunção Ventricular Direita , Criança , Humanos , Estudos Retrospectivos , Bronquite/diagnóstico , Bronquite/tratamento farmacológico , Bronquite/etiologia , Broncoscopia , Corticosteroides , Cardiopatias Congênitas/cirurgia
19.
Medicine (Baltimore) ; 103(16): e37781, 2024 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-38640326

RESUMO

Several studies have revealed the risk factors for carpal tunnel syndrome (CTS). However, no studies have evaluated the influence of these risk factors on the selection of treatment modalities for CTS. This study aimed to determine the influence of CTS risk factors on the selection of CTS treatment modalities with a focus on corticosteroid injection (CI) and surgery. We conducted a retrospective cohort study of patients aged ≥20 years with newly diagnosed CTS in the Korean health insurance review and assessment service between 2010 and 2019. We evaluated the demographic information, the existence of CTS risk factors, and the applied treatment modalities for CTS, including CI and operation. The CTS risk factors include age, sex, diabetes mellitus, osteoarthritis of the hand or wrist, rheumatoid arthritis, hypothyroidism, gout, chronic kidney disease (CKD) on dialysis, antiestrogen or aromatase inhibitor medication, and a history of distal radius fracture (DRF). Multivariable logistic regression analyses were conducted. Age over 80 years was the most significantly associated factor for the selection of CI in CTS (odd ratio [OR], 2.149; 95% confidence interval [CI], 2.092 to 2.209; P < .001). Among underlying diseases or medications, CKD on dialysis (OR, 4.001; 95% CI, 3.819-4.193; P < .001) was the most significant associated factor for the selection of operation for CTS, followed by a history of DRF (OR, 1.803; 95% CI, 1.749-1.860; P < .001). Old age was the most significantly related factor for selecting CI. Among underlying diseases or medications, CKD on dialysis and the history of DRF were the most significantly related factors for selecting operative treatment. For these patients, clinicians should proactively consider an operation to reduce the long-term discomfort and economic burdens.


Assuntos
Síndrome do Túnel Carpal , Insuficiência Renal Crônica , Humanos , Síndrome do Túnel Carpal/epidemiologia , Síndrome do Túnel Carpal/etiologia , Síndrome do Túnel Carpal/cirurgia , Estudos Retrospectivos , Diálise Renal/efeitos adversos , Fatores de Risco , Corticosteroides/uso terapêutico , Insuficiência Renal Crônica/complicações
20.
Trials ; 25(1): 258, 2024 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-38609983

RESUMO

BACKGROUND: Preterm birth complications are the leading cause of newborn and under-5 mortality. Over 85% of all preterm births occur in the late preterm period, i.e. between 34 and < 37 weeks of gestation. Antenatal corticosteroids (ACS) prevent mortality and respiratory morbidity when administered to women at high risk of an early preterm birth, i.e. < 34 weeks' gestation. However, the benefits and risks of ACS in the late preterm period are less clear; both guidelines and practices vary between settings. Emerging evidence suggests that the benefits of ACS may be achievable at lower doses than presently used. This trial aims to determine the efficacy and safety of two ACS regimens compared to placebo, when given to women with a high probability of late preterm birth, in hospitals in low-resource countries. METHODS: WHO ACTION III trial is a parallel-group, three-arm, individually randomized, double-blind, placebo-controlled trial of two ACS regimens: dexamethasone phosphate 4 × 6 mg q12h or betamethasone phosphate 4 × 2 mg q 12 h. The trial is being conducted across seven sites in five countries-Bangladesh, India, Kenya, Nigeria, and Pakistan. Eligible women are those with a gestational age between 34 weeks 0 days and 36 weeks 5 days, who have a high probability of preterm birth between 12 h and 7 days (up to 36 weeks 6 days gestation). The primary outcome is a composite of stillbirth or neonatal death within 72 h of birth or use of newborn respiratory support within 72 h of birth or prior to discharge from hospital, whichever is earlier. Secondary outcomes include safety and health utilization measures for both women and newborns. The sample size is 13,500 women. DISCUSSION: This trial will evaluate the benefits and possible harms of ACS when used in women likely to have a late preterm birth. It will also evaluate a lower-dose ACS regimen based on literature from pharmacokinetic studies. The results of this trial will provide robust critical evidence on the safe and appropriate use of ACS in the late preterm period internationally. TRIAL REGISTRATION: ISRCTN11434567 . Registered on 7 June 2021.


Assuntos
Nascimento Prematuro , Recém-Nascido , Gravidez , Humanos , Feminino , Nascimento Prematuro/prevenção & controle , Corticosteroides/efeitos adversos , Método Duplo-Cego , Hospitais , Probabilidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
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