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Peripheral venous catheter fracture with cardiovascular embolization is a rare but potentially serious complication. Herein, we report a case of peripheral venous catheter fracture with embolization in right ventricle in a preterm infant. The catheter fragment was successfully removed by surgical procedure via median sternotomy under cardiopulmonary bypass(CPB).We hope this case will increase awareness of this rare complication and improve cannulation safety.
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Cateterismo Periférico , Remoção de Dispositivo , Recém-Nascido Prematuro , Humanos , Recém-Nascido , Cateterismo Periférico/métodos , Remoção de Dispositivo/métodos , Falha de Equipamento , Ventrículos do Coração/cirurgiaRESUMO
BACKGROUND: Invasive fungal infection (IFI) has become an increasing problem in NICU neonates, and end-organ damage (EOD) from IFI is one of the leading causes of morbidity and mortality in neonates. This study was conducted to summarize clinical data on epidemiology, risk factors, causative pathogens, and clinical outcomes of IFI-associated EOD among neonates in a center in China for the sake of providing references for prevention and treatment of fungal infections in neonates in future. METHODS: The clinical data of IFI neonates who received treatment in a tertiary NICU of China from January 2009 to December 2022 were retrospectively analyzed, including causative pathogens and the incidence of EOD. The neonates were divided into EOD group and non-EOD (NEOD) group. The general characteristics, risk factors and clinical outcomes of the two groups were compared. RESULTS: Included in this study were 223 IFI neonates (137 male and 86 female) with a median gestational age (GA) of 30.71 (29,35) weeks and a median birth weight (BW) of 1470 (1120,2150) g. Of them, 79.4% were preterm infants and 50.2% were born at a GA of ≥ 28, <32 weeks, and 37.7% with BW of 1000-1499 g. Candida albicans (C. albicans) was the most common Candida spp. in these neonates, accounting for 41.3% of all cases, followed by C. parapsilosis (30.5%) and C. glabrata (7.2%). EOD occurred in 40 (17.9%) of the 223 cases. Fungal meningitis was the most common EOD, accounting for 13.5% of the 40 EOD cases. There was no significant difference in the premature birth rate, delivery mode, GA and BW between EOD and NEOD groups, but the proportion of male infants with EOD was higher than that without. There was no significant difference in antenatal corticosteroid use, endotracheal intubation, invasive procedures, use of antibiotics, total parenteral nutrition, blood transfusion, postnatal corticosteroid use, fungal prophylaxis and the incidence of necrotizing enterocolitis between the two groups, but the proportion of C. albicans infection cases in EOD group was higher than that in NEOD group (57.5% vs. 37.7%). Compared with NEOD group, the proportion of cured or improved infants in EOD group was significantly lower (P < 0.05), and the number of infants who died or withdrew from treatment was larger (P < 0.05). CONCLUSIONS: Our retrospective study showed that preterm infants were prone to fungal infection, especially very preterm infants. C. albicans was the most common Candida spp. for IFI, and was a high-risk factor for EOD. EOD can occur in both full-term and premature infants, so the possibility of EOD should be considered in all infants with IFI.
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Infecções Fúngicas Invasivas , Centros de Atenção Terciária , Humanos , Recém-Nascido , Estudos Retrospectivos , Feminino , Masculino , China/epidemiologia , Infecções Fúngicas Invasivas/epidemiologia , Infecções Fúngicas Invasivas/tratamento farmacológico , Infecções Fúngicas Invasivas/microbiologia , Centros de Atenção Terciária/estatística & dados numéricos , Fatores de Risco , Incidência , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Recém-Nascido Prematuro , Antifúngicos/uso terapêutico , Idade GestacionalRESUMO
The SARS-CoV-2, responsible for the COVID-19 pandemic, poses a significant threat to global healthcare. Peptide and peptide-based inhibitors, known for their safety, efficacy, and selectivity, have recently emerged as promising candidates for treating late-developing viral infections. In this study, three peptides were selected to target different stages of viral invasion, specifically ACE2 and S protein binding, as well as membrane fusion. The objective was to assess their ability to impede the entry of the SARS-CoV-2 Spike pseudotyped virus. Our findings revealed that a combination of these three peptides demonstrated enhanced antiviral effects. This outcome substantiates the feasibility of developing effective peptide combinations to combat diseases related to SARS-CoV-2. Moreover, the three-peptide combinations, designed to target multiple aspects of SARS-CoV-2 viral entry, exhibited heightened viral inhibition and broad-spectrum antiviral properties.
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BACKGROUND: Bronchopulmonary dysplasia-associated pulmonary hypertension (BPD-PH) remains a devastating clinical complication seriously affecting the therapeutic outcome of preterm infants. Hence, early prevention and timely diagnosis prior to pathological change is the key to reducing morbidity and improving prognosis. Our primary objective is to utilize machine learning techniques to build predictive models that could accurately identify BPD infants at risk of developing PH. METHODS: The data utilized in this study were collected from neonatology departments of four tertiary-level hospitals in China. To address the issue of imbalanced data, oversampling algorithms synthetic minority over-sampling technique (SMOTE) was applied to improve the model. RESULTS: Seven hundred sixty one clinical records were collected in our study. Following data pre-processing and feature selection, 5 of the 46 features were used to build models, including duration of invasive respiratory support (day), the severity of BPD, ventilator-associated pneumonia, pulmonary hemorrhage, and early-onset PH. Four machine learning models were applied to predictive learning, and after comprehensive selection a model was ultimately selected. The model achieved 93.8% sensitivity, 85.0% accuracy, and 0.933 AUC. A score of the logistic regression formula greater than 0 was identified as a warning sign of BPD-PH. CONCLUSIONS: We comprehensively compared different machine learning models and ultimately obtained a good prognosis model which was sufficient to support pediatric clinicians to make early diagnosis and formulate a better treatment plan for pediatric patients with BPD-PH.
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Displasia Broncopulmonar , Hipertensão Pulmonar , Aprendizado de Máquina , Humanos , Displasia Broncopulmonar/diagnóstico , Recém-Nascido , Hipertensão Pulmonar/diagnóstico , Masculino , Feminino , Estudos Retrospectivos , Lactente Extremamente Prematuro , Recém-Nascido PrematuroRESUMO
BACKGROUND: The standardised management of neonatal critical care centres can help improve health outcomes of vulnerable newborns. Guidance is required to update evidence related to construction and management of neonatal critical care centres in China. OBJECTIVE: To establish expert consensus on the essential capability lists for neonatal critical care at three levels in China. DESIGN AND SETTING: According to China's administrative divisions, the Chinese guidelines stratifies neonatal critical care into three levels: county level (basic and special care), city level (intensive care) and province level (comprehensive care including neonatal surgery and more subspecialty interventions). A modified Delphi study was conducted. A group of 20 neonatologists from the Chinese Association of Neonatologists rated the importance of capability items on a 5-point Likert scale. RESULTS: At county level, the list consisted of 29 items related to basic and special care, and 3 items were unanimously rated very important by all experts: neonatal resuscitation, endotracheal intubation and continuous positive airway pressure ≥72 hours. At city level, group consensus defined 38 items as essential. Besides the essential items of county level, more items for intensive care were included in city level. At province level, 64 items reached consensus, including neonatal surgery and more advanced subspecialty interventions. The Kendall's W values showed good agreement among experts in both rounds, and an increase from round 1 to round 2. CONCLUSIONS: We developed the capability lists for neonatal critical care at three levels in China. Neonatal resuscitation should be provided by all levels. Interventions for preterm newborns are stratified according to gestational age and birth weight. Congenital abnormalities requiring surgical services need to be managed in high-level centres.
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Cuidados Críticos , Ressuscitação , Humanos , Recém-Nascido , Técnica Delphi , Intubação Intratraqueal , ChinaRESUMO
Objective: Extracorporeal membrane oxygenation (ECMO) is an advanced life support that has been utilized in the neonate for refractory respiratory and circulatory failure. Striving for the best outcomes and understanding optimal surgical techniques continue to be at the forefront of discussion and research. This study presents a single-center experience of cervically cannulated neonatal patients on V-A ECMO, a description of our cannulation/decannulation techniques and our patient outcomes. Methods: Single center retrospective review of neonates who received neck V-A ECMO support from January 2012 to December 2022. The data and outcomes of the patients were retrospectively analyzed. Results: A total of 78 neonates received V-A ECMO support. There were 66 patients that received ECMO for respiratory support, the other 12 patients that received ECMO for cardiac support. The median duration of ECMO support was 109 (32-293) hours for all patients. During ECMO support, 20 patients died and 5 patients discontinued treatment due to poor outcome or the cost. A total of 53 (68%) patients were successfully weaned from ECMO, but 3 of them died in the subsequent treatment. Overall 50 (64%) patients survived to hospital discharge. In this study, 48 patients were cannulated using the vessel sparing technique, the other 30 patients were cannulated using the ligation technique. We found no significant difference in the rates of normal cranial MRI at discharge between survivors with and without common carotid artery ligation. Conclusion: We achieved satisfactory outcomes of neonatal ECMO in 11-year experience. This study found no significant difference in early neuroimaging between survivors with and without common carotid artery ligation. The long-term neurological function of ECMO survivors warranted further follow-up and study.
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Background and Aims: Neonatal diseases are a significant threat to global public health, affecting the homeostasis and well-being of patients and reflecting the status of, and challenges to, regional, national, and global healthcare systems. This study sought to investigate how the disease spectrum observed among neonatal inpatients changed after the onset of the coronavirus disease 2019 (COVID-19) pandemic. Methods: The present hospital-based retrospective study analyzed the demographic and clinical characteristics of 19,943 hospitalized newborns from January 2018 to December 2022 using data derived from pediatric department registers. Results: According to the International Classification of Diseases 11th Revision (ICD-11) classification criteria, the two most common neonatal disorders during this study period were "Certain conditions originating in the perinatal period" and "Disease of the respiratory system." Following the start of the COVID-19 pandemic (2020 onwards), the number of neonatal patients declined markedly (5742 per year vs. 2820 per year), and the incidence of "Disease of the respiratory system" was significantly lower than in 2018-2019 (25.72% vs. 17.46%). Conclusion: The study offers detailed insights into the shifts in neonatal disease patterns at the Seventh Medical Center of the PLA General Hospital following the onset of the COVID-19 pandemic, providing a foundation for future research and policymaking efforts.
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Acute respiratory distress syndrome (ARDS) is the primary cause of respiratory failure in critically ill patients. Despite remarkable therapeutic advances in recent years, ARDS remains a life-threatening clinical complication with high morbidity and mortality, especially during the global spread of the coronavirus disease 2019 (COVID-19) pandemic. Previous studies have demonstrated that mesenchymal stem cell (MSC)-based therapy is a potential alternative strategy for the treatment of refractory respiratory diseases including ARDS, while extracorporeal membrane oxygenation (ECMO) as the last resort treatment to sustain life can help improve the survival of ARDS patients. In recent years, several studies have explored the effects of ECMO combined with MSC-based therapies in the treatment of ARDS, and some of them have demonstrated that this combination can provide better therapeutic effects, while others have argued that some critical issues need to be solved before it can be applied to clinical practice. This review presents an overview of the current status, clinical challenges and future prospects of ECMO combined with MSCs in the treatment of ARDS.
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BACKGROUND: Necrotizing enterocolitis (NEC) is the most common severe gastrointestinal emergency in neonates. We designed this study to identify the pathogenic microorganisms of NEC in the microbiota of the small intestine of neonates. METHODS: Using the 16S ribosomal DNA (rDNA) sequencing method, we compared and analyzed the structure and diversity of microbiotas in the intestinal feces of different groups of neonates: patients undergoing jejunostomy to treat NEC (NP group), neonates undergoing jejunostomy to treat other conditions (NN group), and neonates with NEC undergoing conservative treatment (NC group). We took intestinal feces and saliva samples from patients at different time points. RESULTS: The beta diversities of the NP, NN, and NC groups were all similar. When comparing the beta diversities between different time points in the NP group, we found similar beta diversities at time points E1 to E3 but significant differences between the E2-E3 and E4 time points: the abundances of Klebsiella and Enterococcus (Proteobacteria) were higher at the E1-E3 time points; the abundance of Escherichia-Shigella (Proteobacteria) increased at the E2 time point, and the abundance of Klebsiella decreased significantly, whereas that of Streptococcus increased significantly at the E4 time point. CONCLUSIONS: Our results suggest that the pathological changes of intestinal necrosis in the small intestine of infants with NEC are not directly caused by excessive proliferation of pathogenic bacteria in the small intestine. The sources of microbiota in the small intestine of neonates, especially in premature infants, may be affected by multiple factors.
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Enterocolite Necrosante , Doenças Fetais , Doenças do Recém-Nascido , Lactente , Feminino , Recém-Nascido , Humanos , RNA Ribossômico 16S/genética , Recém-Nascido Prematuro , Intestinos/microbiologia , Intestino DelgadoRESUMO
Objectives: Neonatologists and obstetricians are crucial decision-makers regarding the resuscitation of extremely preterm infants (EPIs). However, there is a scarcity of research regarding the differing perspectives on EPI resuscitation between these medical professionals. We aim to determine the differences and influential factors of their attitudes towards EPIs resuscitation in China. Methods: This cross-sectional study was conducted in public hospitals of 31 provinces in Chinese mainland from June to July 2021. Influential factors of binary variables and those of ordinal variables were analyzed by modified Poisson regression models and multinomial logistic regression models due to the invalid parallel line assumption of ordinal logistic regression models. Results: A total of 832 neonatologists and 1,478 obstetricians who were deputy chief physicians or chief physicians participated. Compared with obstetricians, neonatologists delivered a larger proportion of infants of <28-week gestational age (87.74% vs. 84.91%) and were inclined to think it inappropriate to use 28 weeks as the cutoff of gestational age for providing full care to premature infants [63.34% vs. 31.60%, adjusted prevalence ratio = 1.61 (95% CI: 1.46-1.77)], and to suggest smaller cutoffs of gestational age and birth weight for providing EPIs resuscitation. Notably, 46.49% of the neonatologists and 19.01% of the obstetricians believed infants ≤24 weeks' gestation should receive resuscitation. Conclusions: In China, notable disparities exist in attitudes of neonatologists and obstetricians towards resuscitating EPIs. Strengthening collaboration between these two groups and revising the pertinent guidelines as soon as possible would be instrumental in elevating the resuscitation rate of EPIs.
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This retrospective study was conducted in a neonatal intensive care unit in Beijing. Patients whose blood culture yielded Candida utilis during hospitalisation from January 2009 to December 2017 were enrolled. Thirteen preterm infants of median gestational age 29.85 weeks were included. Laboratory tests on the day of onset showed thrombocytopaenia in 11 patients, granulocytopaenia in eight and elevated C-reactive protein in seven. No fungal endophthalmitis, renal infection, carditis or involvement of other end organs was observed in any of the cases. All 13 patients were cured after fluconazole therapy.
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Candida , Candidemia , Lactente , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Estudos Retrospectivos , Antifúngicos/uso terapêutico , Candidemia/diagnóstico , Candidemia/tratamento farmacológico , Candidemia/microbiologiaRESUMO
BACKGROUND: This article summarizes the treatment experience for congenital complete atrioventricular block (CCAVB) in newborns and infants, and discusses the necessity and feasibility of treating CCAVB with permanent pacemaker implantation in this population. METHODS: In this study, the clinical data and follow-up results of nine children admitted at our center with CCAVB from January 2005 to March 2023 were retrospectively analyzed. Among them, two children received early implantation of permanent pacemakers (within 1 year of age), two children received non-early implantation (1 year or older), and the remaining five children received no pacemaker implantation. CCAVB diagnosis was confirmed by clinical symptoms and clinical examinations, including electrocardiography and echocardiography before surgery. After surgery, the pacing and sensing functions of the pacemaker were observed using electrocardiography, echocardiography, and pacing threshold monitoring. A comprehensive assessment of the treatment efficacy was conducted, encompassing improvements in clinical symptoms, growth and development, as well as the absence of any additional potential complications. The children who did not receive pacemaker implantation were followed up. RESULTS: Among the four children who successfully received pacemaker implantation, one child who received non-early implantation died. For the remaining three children, the threshold level, amplitude, impedance, and minute ventilation sensor function of the pacemaker were good during the follow-up period, with a heart rate at the pacing rate. The growth and development of the aforementioned patients who received pacemaker implantation demonstrated adherence to the percentile curve, and their motor and cognitive development remained unaffected. However, among the children who did not undergo pacemaker implantation, two experienced death, while three were lost to follow-up, thereby limiting the evaluation of their long-term outcomes. CONCLUSIONS: Early implantation of an epicardial pacemaker at an early stage in newborns and infants diagnosed with CCAVB can significantly improve clinical symptoms without affecting their growth and development. These data are in line with current literature and suggest that early implantation of an epicardial pacemaker in newborns and infants diagnosed with CCAVB but further studies are needed.
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Bloqueio Atrioventricular , Marca-Passo Artificial , Criança , Humanos , Lactente , Recém-Nascido , Pré-Escolar , Estudos Retrospectivos , Bloqueio Atrioventricular/diagnóstico , Bloqueio Atrioventricular/etiologia , Bloqueio Atrioventricular/terapia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/métodos , SeguimentosRESUMO
BACKGROUND: Nonpharmacological interventions for COVID-19 could reduce the incidence of children hospitalized in pediatric intensive care units (PICU) and the incidence of children with bacterial infections. This study aimed to evaluate changes in the bacterial profile of children in PICU before and during the COVID-19 pandemics. METHODS: This is a retrospective study, involving clinical data of children with positive bacterial cultures admitted to the PICU respectively in 2019 and 2021. RESULTS: In total 652 children were included in this study. The total number of hospitalized patients and the incidence of bacteria-positive children in 2021 were lower than those in 2019. There were no significant differences in the ratio of Gram-positive bacterial infection, Gram-negative bacteria infection or fungi infection between the two years. The rate of Streptococcus pneumoniae in 2021 was higher than that in 2019(p = 0.127). The incidence of Haemophilus influenzae in hospitalized patients decreased with a downward trend(p = 0.002). The distribution of previous underlying diseases in children admitted to PICU with different outcomes of bacterial infection between the two years were homogeneous (p > 0.05). CONCLUSION: After the implementation of COVID-19 isolation, prevention and control measures, the number of hospitalizations and bacterial infections in PICU decreased, which may be due to changes in population's behavior patterns. Meanwhile, the incidence of Haemophilus influenzae in hospitalized patients decreased with a downward trend.
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COVID-19 , Infecções por Bactérias Gram-Positivas , Criança , Humanos , SARS-CoV-2 , Estudos Retrospectivos , COVID-19/epidemiologia , Pandemias , Unidades de Terapia Intensiva PediátricaRESUMO
High-flow nasal cannula (HFNC) oxygen therapy, which is important in noninvasive respiratory support, is increasingly being used in critically ill neonates with respiratory failure because it is comfortable, easy to setup, and has a low incidence of nasal trauma. The advantages, indications, and risks of HFNC have been the focus of research in recent years, resulting in the development of the application. Based on current evidence, we developed guidelines for HFNC in neonates using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). The guidelines were formulated after extensive consultations with neonatologists, respiratory therapists, nurse specialists, and evidence-based medicine experts. We have proposed 24 recommendations for 9 key questions. The guidelines aim to be a source of evidence and reference of HFNC oxygen therapy in clinical practice, and so that more neonates and their families will benefit from HFNC.
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Cânula , Insuficiência Respiratória , Recém-Nascido , Humanos , Oxigenoterapia/métodos , Insuficiência Respiratória/terapia , Medicina Baseada em Evidências , OxigênioRESUMO
Background: Congenital heart diseases (CHDs) are conditions that involve structural problems to the heart's structure existing at birth, with an incidence of approximately 8 per 1,000 live births globally. CHD is one of the leading causes of maternal, fetal, and neonatal morbidity and mortality worldwide. The present study sought to examine the clinical profiles of CHD patients and provide important implications for therapeutic interventions. Methods: This was a retrospective, observational, cohort study. The medical records of all CHDs patients aged between 0 and 18 years were collected from July 1, 2021 to June 30, 2022. Clinical profiles and demographic data were collected from cardiology and pediatric department registers for analysis. Results: Of the 265 children with CHDs, 201 were diagnosed with acyanotic CHD (ACHD), while 64 children had cyanotic CHD (CCHD). Based on the eleventh revision of the International Classification of Diseases (ICD-11), "congenital anomaly of a ventricle or the ventricular septum" was the most common CHD. The most common symptom was failure to thrive, accounting for 18.5% of all CHD cases. The most frequent symptom in ACHD was murmur (93.53%) and sweating (80.60%), whereas the most common symptom in CCHD was sweating (95.31%) and cyanosis (84.38%). Conclusions: This study retrospectively analyzed CHD clinical characteristics from children receiving care at the seventh center, which forms a proper basis for appropriate clinical treatments and further studies.
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INTRODUCTION: This study aimed to investigate the relationship between blood lactate level and mortality in pediatric patients receiving extracorporeal membrane oxygenation (ECMO) for severe cardiopulmonary failure. METHODS: A retrospective observational study was conducted on pediatric patients who received ECMO from January 2013 to December 2021 at the Seventh Medical Center of PLA General Hospital. Patient demographic characteristics, arterial blood lactate level prior to ECMO (pre-ECMO), ECMO settings, ECMO duration, and 30-days mortality were retrieved from patients' medical records. The relationships between pre-ECMO blood lactate level and mortality were interpreted using the logistic regression analysis and Kaplan-Meier survival analysis. RESULTS: A total of 160 pediatric patients who had either refractory respiratory failure (n = 89) or circulatory failure (n = 71) and received ECMO were included in this study. In both the respiratory failure and circulatory failure groups, the non-survivors showed a higher mean pre-ECMO arterial blood lactate level than the survivors. In the respiratory failure group, a pre-ECMO lactate concentration at ≥11.6 mmol/L had a sensitivity of 51% and a specificity of 82% for predicting mortality. In the circulatory failure group, a pre-ECMO lactate concentration at ≥7.2 mmol/L had a sensitivity of 90% and a specificity of 57% for predicting mortality. The Kaplan-Meier survival curves showed that respiratory failure patients with a pre-ECMO lactate level over 11.6 mmol/L or circulatory failure patients with a pre-ECMO lactate level over 7.2 mmol/L had a higher 30-days mortality rate than those with a lower lactate level. CONCLUSIONS: High pre-ECMO arterial blood lactate level serves as an independent risk factor for mortality in pediatric patients who receive ECMO for severe cardiopulmonary failure.
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Objectives: To determine the COVID-19 vaccination rate in preterm-born children aged 3-7 in China and influential factors, identify vaccination-related adverse reactions, and clarify reasons behind parental refusal of vaccination to their children. Methods: This cross-sectional study was conducted in parents of preterm-born children aged 3-7 in different regions of China through WeChat. Results: Of 1,924 Chinese preterm-born children aged 3-7 included in this study, 1,552 (80.7%) had been vaccinated against COVID-19, with a higher vaccination rate in eastern China. Children older than 4 years, kids in kindergartens and primary schools, children living in eastern or western China, and children whose fathers had received at least one dose of a COVID-19 vaccine tended to be vaccinated against COVID-19 after adjusting for other covariates. Conversely, children living in urban areas, children whose annual family income was < 50,000 CNY or more than 300,000 CNY, premature children who underwent hospital transfers, and children with underlying diseases were less likely to get vaccinated. Adverse reactions occurred in 59/1,552 (3.8%) vaccinated children. Parents of 118/372 (31.7%) children expressed their concerns over adverse reactions to COVID-19 vaccination. Other reasons like the absence of information about the place where they could get vaccination were mentioned as well. Conclusions: COVID-19 vaccination-related adverse reactions rarely occurred and most of them were mild among preterm-born children aged 3-7. Higher vaccination coverage can be achieved as parents are provided with more scientific data about benefits of vaccination, vaccination contraindications and precautions, and more information about vaccination sites.
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Vacinas contra COVID-19 , COVID-19 , Recém-Nascido , Humanos , Criança , Pré-Escolar , COVID-19/prevenção & controle , Estudos Transversais , Vacinação , ChinaRESUMO
INTRODUCTION: This retrospective study aimed to compare a range of conditioning regimens in children with severe aplastic anemia (SAA) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the Seventh Medical Center of PLA General Hospital between January 2008 and June 2017. METHODS: Patients were categorized into the Bu (Bu + Flu + Cy + ATG-F regimen) and control (Flu + Cy + ATG-F) groups, with a median follow-up time after HSCT of 3.5 (range, 3.1-6.2) and 3.7 (3.2-5.9) years in the Bu and control groups, respectively. RESULTS: No differences were observed between the two groups regarding the median time of peripheral blood neutrophil and platelet engraftment (p = 0.538 and p = 0.491); the 28-day engraftment rates of neutrophils were similar (p = 0.199), although higher for platelets with Bu (p = 0.044). Additionally, graft failure was 0% and 20.0% in the Bu and control groups, respectively (p = 0.004). In both groups, the incidence of grades III-IV (or grades II-IV) acute graft-versus-host disease (GVHD) and chronic GVHD was not significantly different (p > 0.05). Moreover, the 3-year overall survival and failure-free survival did not show significant differences (p = 0.670 and p = 0.908). DISCUSSION: In children with SAA undergoing allo-HSCT, conditioning regimen with Bu + Flu + Cy + ATG-F is capable of enhancing the myeloablation effect, promoting donor hematopoietic stem cell engraftment, and reducing the graft failure rate. Furthermore, it does not increase the incidence of complications, including GVHD.
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Anemia Aplástica , Doença Enxerto-Hospedeiro , Transplante de Células-Tronco Hematopoéticas , Criança , Humanos , Bussulfano/uso terapêutico , Estudos Retrospectivos , Anemia Aplástica/terapia , Doença Enxerto-Hospedeiro/etiologia , Doença Enxerto-Hospedeiro/prevenção & controle , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Condicionamento Pré-Transplante , CiclofosfamidaRESUMO
Importance: The NASONE (Nasal Oscillation Post-Extubation) trial showed that noninvasive high-frequency oscillatory ventilation (NHFOV) slightly reduces the duration of invasive mechanical ventilation (IMV) in preterm infants, whereas NHFOV and noninvasive intermittent positive pressure ventilation (NIPPV) result in fewer reintubations than nasal continuous positive airway pressure (NCPAP). It is unknown whether NHFOV is similarly effective in extremely preterm neonates or in those with more severe respiratory failure (based on the duration of previous ventilation and CO2 levels). Objective: To clarify whether NHFOV is better than NIPPV and NCPAP in reducing the duration of IMV in extremely preterm neonates or those with severe respiratory failure. Design, Setting, and Participants: This study is a predefined secondary analyses of a multicenter randomized clinical trial that was performed at tertiary academic neonatal intensive care units (NICUs) in China. Participants included neonates enrolled in the NASONE trial between December 2017 and May 2021 and belonging to 3 predefined subgroups: (1) born at less than or equal to 28 weeks' (plus 6 days) gestation, (2) invasively ventilated for more than 1 week from birth, and (3) with CO2 greater than 50 mm Hg before or in the 24 hours after extubation. Data analysis was performed in August 2022. Intervention: NCPAP, NIPPV, or NHFOV since the first extubation and until NICU discharge, with airway pressure higher in NHFOV than in NIPPV and than in NCPAP. Main Outcomes and Measures: The co-primary outcomes were total duration of IMV during the NICU stay, need for reintubation, and ventilator-free days calculated as per the original trial protocol. Outcomes were analyzed on an intention-to-treat basis as for the whole trial, and subgroup analyses followed the original statistical plan. Results: Among 1137 preterm infants, 455 (279 boys [61.3%]) were born at 28 weeks' gestation or less, 375 (218 boys [58.1%]) underwent IMV for more than 1 week from birth, and 307 (183 boys [59.6%]) had CO2 greater than 50 mm Hg before or in the 24 hours after extubation. Both NIPPV and NHFOV were associated with significantly fewer reintubations (risk difference range, -28% [95% CI, -39% to -17%] to -15% [95% CI, -25% to -4%]; number needed to treat, 3-7 infants) and early reintubations (risk difference range, -24% [95% CI, -35% to -14%] to -20% [95% CI, -30% to -10%]) than NCPAP, and these reintubations were less frequently due to refractory hypoxemia. IMV was shorter in the NIPPV and NHFOV groups (mean difference range, -5.0 days [95% CI, -6.8 to -3.1 days] to -2.3 days [95% CI, -4.1 to -0.4 days]) than in the NCPAP group. Co-primary outcomes were not different between NIPPV and NHFOV; there was no significant interaction effect. Infants in the NHFOV group showed significantly less moderate-to-severe bronchopulmonary dysplasia than infants in the NCPAP group (range, -12% to -10%; number needed to treat, 8-9 infants) and better postextubation gas exchange in all subgroups. The 3 interventions were provided at different mean airway pressure and were equally safe. Conclusions and Relevance: The subgroup analyses of extremely preterm or more ill infants confirm the results obtained in the whole population: NIPPV and NHFOV appeared equally effective in reducing duration of IMV compared with NCPAP. Trial Registration: ClinicalTrials.gov Identifier: NCT03181958.