The use of pulmonary function tests (PFTs) has been widely described in airway diseases like asthma and cystic fibrosis, but for children's interstitial lung disease (chILD), which encompasses a broad spectrum of pathologies, the usefulness of PFTs is still undetermined, despite widespread use in adult interstitial lung disease. A literature review was initiated by the COST/Enter chILD working group aiming to describe published studies, to identify gaps in knowledge and to propose future research goals in regard to spirometry, whole-body plethysmography, infant and pre-school PFTs, measurement of diffusing capacity, multiple breath washout and cardiopulmonary exercise tests in chILD. The search revealed a limited number of papers published in the past three decades, of which the majority were descriptive and did not report pulmonary function as the main outcome.PFTs may be useful in different stages of management of children with suspected or confirmed chILD, but the chILD spectrum is diverse and includes a heterogeneous patient group in all ages. Research studies in well-defined patient cohorts are needed to establish which PFT and outcomes are most relevant for diagnosis, evaluation of disease severity and course, and monitoring individual conditions both for improvement in clinical care and as end-points in future randomised controlled trials.

• MeSH
• dítě MeSH
• intersticiální plicní nemoci diagnóza   patofyziologie   MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• předškolní dítě MeSH
• respirační funkční testy * MeSH
• věkové faktory MeSH
• Check Tag
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• předškolní dítě MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

OBJECTIVES: Riociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression. METHODS: In this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10-22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52. RESULTS: At week 52, change from baseline in mRSS units was -2.09±5.66 (n=57) with riociguat and -0.77±8.24 (n=52) with placebo (difference of least squares means -2.34 (95% CI -4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud's condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths. CONCLUSIONS: Riociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.

• MeSH
• aktivátory enzymů aplikace a dávkování   MeSH
• difuzní sklerodermie farmakoterapie   patologie   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• hodnocení rizik MeSH
• imunohistochemie MeSH
• internacionalita MeSH
• jehlová biopsie MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• neúspěšná terapie MeSH
• pyrazoly aplikace a dávkování   MeSH
• pyrimidiny aplikace a dávkování   MeSH
• respirační funkční testy MeSH
• rozvrh dávkování léků MeSH
• stupeň závažnosti nemoci MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

• MeSH
• cystická fibróza farmakoterapie   MeSH
• dítě MeSH
• lidé MeSH
• plicní nemoci farmakoterapie   MeSH
• respirační funkční testy MeSH
• terbutalin aplikace a dávkování   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• srovnávací studie MeSH

BACKGROUND: The aim of our study was to compare the effect of interventricular (VV) delay optimisation in CRT recipients on the basis of systolic dyssynchrony index (SDI) derived from the three-dimensional echocardiography (3DE) versus QRS width assessment on left ventricle volume reduction at the 12-month follow-up. METHODS: We included 63 patients with recently implanted CRT in this randomised, open-label trial. Patients were randomised to VV delay optimisation according to QRS complex width measurement in group 1 (n = 31) to obtain the narrowest QRS complex and SDI in group 2 (n = 32) to achieve its lowest possible value. We evaluated left ventricular end-systolic volume (LVESv), left ventricular ejection fraction (LVEF) and SDI by 3DE before CRT implantation and at a 12-month follow-up in all the patients. We also obtained the New York Heart Association functional class, the 6-minute walk test, the quality of life questionnaire and the level of NT-proBNP. RESULTS: The number of volumetric responders was similar in both groups (17 vs. 20, P = 0.786). There were also no significant differences in the reduction of LVESv (-41 ± 55 mL vs. - 61 ± 51 mL, P = 0.111), improvement in LVEF (+10.1 ± 10.6% vs. + 13.0 ± 9.9%, P = 0.213) or differences in clinical outcomes between both groups at the 12-month follow-up. CONCLUSION: CRT optimisation of interventricular delay using SDI compared with QRS width assessment did not reveal any significant difference in terms of volumetric and clinical response at the 12-month follow-up.

• MeSH
• časové faktory MeSH
• echokardiografie trojrozměrná metody   MeSH
• elektrokardiografie MeSH
• funkce levé komory srdeční fyziologie   MeSH
• kvalita života MeSH
• lidé MeSH
• následné studie MeSH
• převodní systém srdeční patofyziologie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• srdeční arytmie diagnóza   patofyziologie   terapie   MeSH
• srdeční komory diagnostické zobrazování   patofyziologie   MeSH
• srdeční resynchronizační terapie metody   MeSH
• systola MeSH
• výsledek terapie MeSH
• zátěžový test MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: The success rate of in-vitro fertilisation (IVF) remains low and many women undergo multiple treatment cycles. A previous meta-analysis suggested hysteroscopy could improve outcomes in women who have had recurrent implantation failure; however, studies were of poor quality and a definitive randomised trial was needed. In the TROPHY trial we aimed to assess whether hysteroscopy improves the livebirth rate following IVF treatment in women with recurrent failure of implantation. METHODS: We did a multicentre, randomised controlled trial in eight hospitals in the UK, Belgium, Italy, and the Czech Republic. We recruited women younger than 38 years who had normal ultrasound of the uterine cavity and history of two to four unsuccessful IVF cycles. We used an independent web-based trial management system to randomly assign (1:1) women to receive outpatient hysteroscopy (hysteroscopy group) or no hysteroscopy (control group) in the month before starting a treatment cycle of IVF (with or without intracytoplasmic sperm injection). A computer-based algorithm minimised for key prognostic variables: age, body-mass index, basal follicle-stimulating hormone concentration, and the number of previous failed IVF cycles. The order of group assignment was masked to the researchers at the time of recruitment and randomisation. Embryologists involved in the embryo transfer were masked to group allocation, but physicians doing the procedure knew of group assignment and had hysteroscopy findings accessible. Participants were not masked to their group assignment. The primary outcome was the livebirth rate (proportion of women who had a live baby beyond 24 weeks of gestation) in the intention-to-treat population. The trial was registered with the ISRCTN Registry, ISRCTN35859078. FINDINGS: Between Jan 1, 2010, and Dec 31, 2013, we randomly assigned 350 women to the hysteroscopy group and 352 women to the control group. 102 (29%) of women in the hysteroscopy group had a livebirth after IVF compared with 102 (29%) women in the control group (risk ratio 1·0, 95% CI 0·79-1·25; p=0·96). No hysteroscopy-related adverse events were reported. INTERPRETATION: Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate. Further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted. FUNDING: European Society of Human Reproduction and Embryology, European Society for Gynaecological Endoscopy.

• MeSH
• ambulantní chirurgické výkony MeSH
• dospělí MeSH
• fertilizace in vitro * MeSH
• hysteroskopie * MeSH
• lidé MeSH
• narození živého dítěte MeSH
• neúspěšná terapie MeSH
• recidiva MeSH
• těhotenství MeSH
• ženská infertilita terapie   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Evropa MeSH

OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. TRIAL DESIGN: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. PARTICIPANTS: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. INCLUSION CRITERIA: Subjects will be eligible for the trial if they meet all of the following criteria: 1. Adult (≥18 years of age) at time of enrolment; 2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing); 3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy; 4. Moderate or severe ARDS according to Berlin criteria: • Moderate - PaO2/FiO2 100-200 mmHg; • Severe - PaO2/FiO2 < 100 mmHg; 5. Admission to ICU in the last 24 hours. EXCLUSION CRITERIA: Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at least 1 week after the last dose of dexamethasone (sexual abstinence is considered an adequate contraception method); 5. End-of-life decision or patient is expected to die within next 24 hours; 6. Decision not to intubate or ceilings of care in place; 7. Immunosuppression and/or immunosuppressive drugs in medical history: a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days; b) Systemic corticosteroid use before hospitalization; c) Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrolment; d) Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock); 8. Current haematological or generalized solid malignancy; 9. Any contraindication for corticosteroid administration, e.g. • intractable hyperglycaemia; • active gastrointestinal bleeding; • adrenal gland disorders; • presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. Cardiac arrest before ICU admission; 11. Participation in another interventional trial in the last 30 days. INTERVENTION AND COMPARATOR: Dexamethasone solution for injection/infusion is the investigational medicinal product as well as the comparator. The trial will assess two doses, 20 mg (investigational) vs 6 mg (comparator). Patients in the intervention group will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. Patients in the control group will receive dexamethasone 6 mg day 1-10. All authorized medicinal products containing dexamethasone in the form of solution for i.v. injection/infusion can be used. MAIN OUTCOMES: Primary endpoint: Number of ventilator-free days (VFDs) at 28 days after randomisation, defined as being alive and free from mechanical ventilation. SECONDARY ENDPOINTS: a) Mortality from any cause at 60 days after randomisation; b) Dynamics of inflammatory marker (C-Reactive Protein, CRP) change from Day 1 to Day 14; c) WHO Clinical Progression Scale at Day 14; d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge; e) Independence at 90 days after randomisation assessed by Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days through telephone structured interviews using the Barthel Index. RANDOMISATION: Randomisation will be carried out within the electronic case report form (eCRF) by the stratified permuted block randomisation method. Allocation sequences will be prepared by a statistician independent of the study team. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomisation process. The following stratification factors will be applied: • Age <65 and ≥ 65; • Charlson Comorbidity index (CCI) <3 and ≥3; • CRP <150 mg/L and ≥150 mg/L • Trial centre. Patients will be randomised in a 1 : 1 ratio into one of the two treatment arms. Randomisation through the eCRF will be available 24 hours every day. BLINDING (MASKING): This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is calculated to detect the difference of 3 VFDs at 28 days (primary efficacy endpoint) between the two treatment arms with a two-sided type I error of 0.05 and power of 80%. Based on data from a multi-centre randomised controlled trial in COVID-19 ARDS patients in Brazil and a multi-centre observational study from French and Belgian ICUs regarding moderate to severe ARDS related to COVID-19, investigators assumed a standard deviation of VFD at 28 days as 9. Using these assumptions, a total of 142 patients per treatment arm would be needed. After adjustment for a drop-out rate, 150 per treatment arm (300 patients per study) will be enrolled. TRIAL STATUS: This is protocol version 1.1, 15.01.2021. The trial is due to start on 2 February 2021 and recruitment is expected to be completed by December 2021. TRIAL REGISTRATION: The study protocol was registered on EudraCT No.:2020-005887-70, and on December 11, 2020 on ClinicalTrials.gov (Title: Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)) Identifier: NCT04663555 with a last update posted on February 1, 2021. FULL PROTOCOL: The full protocol (version 1.1) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the standard formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

• MeSH
• COVID-19 komplikace   terapie   MeSH
• délka pobytu MeSH
• dexamethason aplikace a dávkování   MeSH
• glukokortikoidy aplikace a dávkování   MeSH
• hodnocení ekvivalence jako téma MeSH
• klinické zkoušky, fáze II jako téma MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• progrese nemoci MeSH
• randomizované kontrolované studie jako téma MeSH
• SARS-CoV-2 MeSH
• syndrom dechové tísně etiologie   terapie   MeSH
• umělé dýchání * MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• dopisy MeSH
• protokol klinické studie MeSH

BACKGROUND: Although several interventions have shown reduced HIV incidence in clinical trials, the community-level effect of effective interventions on the epidemic when scaled up is unknown. We investigated whether a multicomponent, multilevel social and behavioural prevention strategy could reduce HIV incidence, increase HIV testing, reduce HIV risk behaviour, and change social and behavioural norms. METHODS: For this phase 3 cluster-randomised controlled trial, 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV (intervention group) or standard counselling and testing alone (control group) between January, 2001, and December, 2011. The intervention was designed to make testing more accessible in communities, engage communities through outreach, and provide support services after testing. Randomisation was done by a computer-generated code and was not masked. Data were collected at baseline (n=14 567) and after intervention (n=56.683) by cross-sectional random surveys of community residents aged 18-32 years. The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay. Thailand was excluded from incidence analyses because of low HIV prevalence. This trial is registered at ClinicalTrials.gov, number NCT00203749. FINDINGS: The estimated incidence of HIV in the intervention group was 1.52% versus 1.81% in the control group with an estimated reduction in HIV incidence of 13.9% (relative risk [RR] 0.86, 95% CI 0.73-1.02; p=0.082). HIV incidence was significantly reduced in women older than 24 years (RR=0.70, 0.54-0.90; p=0.0085), but not in other age or sex subgroups. Community-based voluntary counselling and testing increased testing rates by 25% overall (12-39; p=0.0003), by 45% (25-69; p<0·0001) in men and 15% (3-28; p=0.013) in women. No overall effect on sexual risk behaviour was recorded. Social norms regarding HIV testing were improved by 6% (95% CI 3-9) in communities in the intervention group. INTERPRETATION: These results are sufficiently robust, especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour, to recommend the Project Accept approach as an integral part of all interventions (including treatment as prevention) to reduce HIV transmission at the community level. FUNDING: US National Institute of Mental Health, the Division of AIDS of the US National Institute of Allergy and Infectious Diseases, and the Office of AIDS Research of the US National Institutes of Health.

• MeSH
• chování snižující riziko * MeSH
• dospělí MeSH
• HIV infekce diagnóza   epidemiologie   prevence a kontrola   MeSH
• hodnocení výsledků zdravotní péče MeSH
• incidence MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• pacientův souhlas se zdravotní péčí * MeSH
• poradenství * MeSH
• spolupráce organizací a občanů * MeSH
• zdravé chování MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Research Support, N.I.H., Extramural MeSH
• Geografické názvy
• Afrika MeSH
• Thajsko MeSH

Východisko. Izolované zvýšení TSH - „subklinická hypotyreóza“ (SH) - je jevem velmi častým, ve věku nad 60 let postihuje až 17 % žen. Zatímco dříve se soudilo, že se jedná o stav zcela asymptomatický, v poslední době se množí důkazy o drobných subjektivních i objektivních příznacích u osob se SH. Metody a výsledky. Autoři vyšetřili 20 jinak zcela zdravých pacientek s diagnózou SH pomocí osobnostního dotazníku MMPI/100, který hodnotí celkem 8 různých klinických škál a dvě škály kontrolní a pomocí Wechslerovy paměťové stupnice WMS-R, která hodnotí celkem 5 paměťových kvocientů. Skupina byla dále randomizována na podskupinu léčenou po dobu půl roku placebem a podskupinu, u které bylo podáváním tyroxinu dosaženo normali- zace tyreoidálních testů, a pak byla opakována psychologická vyšetření. Hodnocení bylo provedeno párovým t-testem. Ze získaných výsledků vyplývá, že: 1) u pacientů se SH nebyly nalezeny statisticky významné rozdíly v osobnostních rysech, pouze jsme registrovali větší sklon k depresivnímu ladění, který byl pozitivně ovlivnitelný terapií tyroxinem (výsledek hraniční pro 5% hladinu významnosti); 2) léčba tyroxinem vedla u osob se SH ke zlepšení některých kognitivních parametrů - verbální (p<0,01), vizuální (p<0,05) a celkové paměti (p<0,01); 3) hodnoty psychologických a kognitivních testů korelují lépe s hladinami FT4 než s TSH. Závěry. SH není spojena se změnami osobnostních rysů, normalizace TSH vede ale ke statisticky významnému zlepšení kognitivních funkcí - paměti verbální, vizuální a celkové.

Background. Isolated TSH increase - „subclinical hypothyreosis“ (SH) appears to be comparatively common. Its incidence among women over sixty has been estimated up to 17 %. Though SH was assumed to be entirely asymptomatic, recent findings revealed various fine subjective and objective symptoms of the disease. Methods and Results. Twenty otherwise healthy female patients with SH diagnosis were examined. Using personality questionnaire MMPI/100 eight different clinical scales and two control scales were evaluated, using Wechsler’s memory scale WM-R 5 memory quotients were tested. The group was randomised i nto a subgroup treated for six month with placebo and a subgroup where thyroxin was administrated and thyroidal test normalised. Psychological testing repeated before and after the treatment, results evaluated using paired t-test. Results indicate that: 1. Patients with SH did not differ in personality features, they only had a higher tendency to the depressive mood, which could be positively influenced by thyroxin (significance at 5 % level). 2. Thyroxin treatment brought about improvement of some cognitive parameters of the verbal (p<0.01), visual (p<0.05), and general memory (p<0.01). 3. Results of psychological and cognitive tests correlate better with FT4 than TSH level. Conclusions. Though SH cannot be associated with changes in personality features, TSH normalisation results in statistically significant improvement of cognitive function - verbal, visual and general memory.

• MeSH
• hypotyreóza diagnóza   farmakoterapie   komplikace   MeSH
• lidé MeSH
• neuropsychologické testy MeSH
• stárnutí patofyziologie   MeSH
• testování osobnosti MeSH
• thyreotropin krev   MeSH
• thyroxin aplikace a dávkování   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH

BACKGROUND: The reflex zone stimulation technique (RST) activates complex motor responses and has a positive impact on the locomotor system. This technique may also indirectly affect breathing; however, the use of this technique as adjunct of the treatment of cystic fibrosis (CF) has not yet been characterised. METHODS: We performed a randomised controlled single-centre interventional trial to evaluate the short-term effects of RST on lung function in 21 paediatric CF patients with normal baseline spirometry. The effect of 30 min of RST was compared to that of sham therapy in a crossover design. The interventions were performed in random order and planned 6 months apart. The primary outcome was a change in global ventilation inhomogeneity after intervention, assessed by lung clearance index (LCI2.5 ) derived from a nitrogen multiple breath washout test. Secondary outcomes included changes in regional ventilation inhomogeneity (indices of acinar [Sacin*Vt] and conductive airway [Scond*Vt] inhomogeneity) and spirometry parameters (inspiratory capacity, forced vital capacity, and forced expiratory volume in 1 s). Trunk deformity was assessed by physiotherapists at study entry. RESULTS: After the RST intervention, the LCI2.5 (p = .004) and Scond*Vt (p = .009) decreased significantly, while inspiratory capacity increased (p = .012). In the sham-therapy group, none of the parameters changed significantly. Trunk deformity was seen in 76.5% of all patients, and 92.9% of those with trunk deformity showed a decrease in LCI2.5 after RST. CONCLUSION: RST has multiple positive short-term effects on lung function, especially in CF patients with trunk deformities.

• MeSH
• cystická fibróza * terapie   MeSH
• dítě MeSH
• dýchání MeSH
• klinické křížové studie MeSH
• lidé MeSH
• plíce MeSH
• plicní ventilace MeSH
• reflex MeSH
• spirometrie MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

INTRODUCTION: Neonatal sepsis is a leading cause of infant mortality worldwide with non-specific and varied presentation. We aimed to catalogue the current definitions of neonatal sepsis in published randomised controlled trials (RCTs). METHOD: A systematic search of the Embase and Cochrane databases was performed for RCTs which explicitly stated a definition for neonatal sepsis. Definitions were sub-divided into five primary criteria for infection (culture, laboratory findings, clinical signs, radiological evidence and risk factors) and stratified by qualifiers (early/late-onset and likelihood of sepsis). RESULTS: Of 668 papers screened, 80 RCTs were included and 128 individual definitions identified. The single most common definition was neonatal sepsis defined by blood culture alone (n = 35), followed by culture and clinical signs (n = 29), and then laboratory tests/clinical signs (n = 25). Blood culture featured in 83 definitions, laboratory testing featured in 48 definitions while clinical signs and radiology featured in 80 and 8 definitions, respectively. DISCUSSION: A diverse range of definitions of neonatal sepsis are used and based on microbiological culture, laboratory tests and clinical signs in contrast to adult and paediatric sepsis which use organ dysfunction. An international consensus-based definition of neonatal sepsis could allow meta-analysis and translate results to improve outcomes.

• MeSH
• dítě MeSH
• dospělí MeSH
• kojenec MeSH
• kojenecká mortalita MeSH
• lidé MeSH
• novorozenec MeSH
• novorozenecká sepse * diagnóza   MeSH
• randomizované kontrolované studie jako téma MeSH
• sepse diagnóza   terapie   MeSH
• Check Tag
• dítě MeSH
• dospělí MeSH
• kojenec MeSH
• lidé MeSH
• novorozenec MeSH
• Publikační typ
• metaanalýza MeSH
• práce podpořená grantem MeSH
• systematický přehled MeSH