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BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. RESULTS: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. CONCLUSIONS: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).
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Lactente Extremamente Prematuro , Doenças do Prematuro , Oximetria , Humanos , Lactente , Recém-Nascido , Lesões Encefálicas/diagnóstico por imagem , Lesões Encefálicas/etiologia , Displasia Broncopulmonar/etiologia , Circulação Cerebrovascular , Doenças do Prematuro/diagnóstico , Doenças do Prematuro/mortalidade , Doenças do Prematuro/terapia , Oximetria/métodos , Cérebro , Ultrassonografia , Retinopatia da Prematuridade/etiologia , Enterocolite Necrosante/etiologia , Sepse Neonatal/etiologiaRESUMO
AIMS/HYPOTHESIS: Body niche-specific microbiota in maternal-neonatal dyads from gravidae with type 1 diabetes have not been quantitatively and functionally examined. Similarly, the impact of pregnancy-specific factors, such as the presence of comorbidities known to occur more frequently among gravidae with type 1 diabetes, including Caesarean delivery, as well as antibiotic prophylaxis, level of glycaemic control during each trimester of pregnancy and insulin administration, has not been adequately considered. The aims of this study were to characterise the maternal and neonatal microbiomes, assess aspects of microbiota transfer from the maternal microbiomes to the neonatal microbiome and explore the impact of type 1 diabetes and confounding factors on the microbiomes. METHODS: In this observational case-control study, we characterised microbiome community composition and function using 16S rRNA amplicon sequencing in a total of 514 vaginal, rectal and ear-skin swabs and stool samples derived from 92 maternal-neonatal dyads (including 50 gravidae with type 1 diabetes) and in-depth clinical metadata from throughout pregnancy and delivery. RESULTS: Type 1 diabetes-specific microbiota were identified among gravidae with type 1 diabetes and their neonates. Neonatal microbiome profiles of ear-skin swabs and stool samples were established, indicating the taxa more prevalent among neonates born to mothers with type 1 diabetes compared with neonates born to control mothers. Without taking into account the type 1 diabetes status of mothers, both delivery mode and intrapartum antibiotic prophylaxis were found to have an influence on neonatal microbiota composition (both p=0.001). In the logistic regression analysis involving all confounding variables, neonatal ear-skin microbiome variation was explained by maternal type 1 diabetes status (p=0.020) and small for gestational age birthweight (p=0.050). Moreover, in women with type 1 diabetes, a relationship was found between HbA1c levels >55 mmol/mol (>7.2%) measured in the first trimester of pregnancy and neonatal ear-skin microbiota composition (p=0.008). In the PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) assessment, pathways concerning carbohydrate biosynthesis were predicted as key elements of the microbial functional profiles dysregulated in type 1 diabetes. Additionally, in SourceTracker analysis, we found that, on average, 81.0% of neonatal microbiota was attributed to maternal sources. An increase in the contribution of maternal rectum microbiota and decrease in the contribution of maternal cervix microbiota were found in ear-skin samples of vaginally delivered neonates of mothers with type 1 diabetes compared with neonates born to control mothers (83.2% vs 59.5% and 0.7% vs 5.2%, respectively). CONCLUSIONS/INTERPRETATION: These findings indicate that, in addition to maternal type 1 diabetes, glycaemic dysregulation before/in the first trimester of pregnancy, mode of delivery and intrapartum antibiotic prophylaxis may contribute to the inoculation and formation of the neonatal microbiomes. DATA AVAILABILITY: The BioProject (PRJNA961636) and associated SRA metadata are available at http://www.ncbi.nlm.nih.gov/bioproject/961636 . Processed data on probiotic supplementation and the PICRUSt analysis are available in the Mendeley Data Repository ( https://doi.org/10.17632/g68rwnnrfk.1 ).
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Diabetes Mellitus Tipo 1 , Microbiota , Recém-Nascido , Gravidez , Humanos , Feminino , RNA Ribossômico 16S/genética , Estudos de Casos e Controles , Filogenia , Microbiota/genéticaRESUMO
OBJECTIVES: To survey practices of iron and recombinant human erythropoietin (rhEpo) administration to infants born preterm across Europe. STUDY DESIGN: Over a 3-month period, we conducted an online survey in 597 neonatal intensive care units (NICUs) of 18 European countries treating infants born with a gestational age of <32 weeks. RESULTS: We included 343 NICUs (response rate 56.3%) in the survey. Almost all NICUs (97.7%) routinely supplement enteral iron, and 74.3% of respondents to all infants born <32 weeks of gestation. We found that 65.3% of NICUs routinely evaluate erythropoiesis and iron parameters beyond day 28 after birth. Most NICUs initiate iron supplementation at postnatal age of 2 weeks and stop after 6 months (34.3%) or 12 months (34.3%). Routine use of rhEpo was reported in 22.2% of NICUs, and in individual cases in 6.9%. RhEpo was mostly administered subcutaneously (70.1%) and most frequently at a dose of 250 U/kg 3 times a week (44.3%), but the dose varied greatly between centers. CONCLUSIONS: This survey highlights wide heterogeneity in evaluating erythropoietic activity and iron deficiency in infants born preterm. Variation in iron supplementation during infancy likely reflects an inadequate evidence base. Current evidence on the efficacy and safety profile of rhEpo is only poorly translated into clinical practice. This survey demonstrates a need for standards to optimize patient blood management in anemia of prematurity.
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OBJECTIVE: To define percentile charts for arterial oxygen saturation (SpO2), heart rate (HR), and cerebral oxygen saturation (crSO2) during the first 15 minutes after birth in neonates born very or extremely preterm and with favorable outcome. STUDY DESIGN: We conducted a secondary-outcome analysis of neonates born preterm included in the Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth III (COSGOD III) trial with visible cerebral oximetry measurements and with favorable outcome, defined as survival without cerebral injuries until term age. We excluded infants with inflammatory morbidities within the first week after birth. SpO2 was obtained by pulse oximetry, and electrocardiogram or pulse oximetry were used for measurement of HR. crSO2 was assessed with near-infrared spectroscopy. Measurements were performed during the first 15 minutes after birth. Percentile charts (10th to 90th centile) were defined for each minute. RESULTS: A total of 207 neonates born preterm with a gestational age of 29.7 (23.9-31.9) weeks and a birth weight of 1200 (378-2320) g were eligible for analyses. The 10th percentile of SpO2 at minute 2, 5, 10, and 15 was 32%, 52%, 83%, and 85%, respectively. The 10th percentile of HR at minute 2, 5, 10, and 15 was 70, 109, 126, and 134 beats/min, respectively. The 10th percentile of crSO2 at minute 2, 5, 20, and 15 was 15%, 27%, 59%, and 63%, respectively. CONCLUSIONS: This study provides new centile charts for SpO2, HR, and crSO2 for neonates born extremely or very preterm with favorable outcome. Implementing these centiles in guiding interventions during the stabilization process after birth might help to more accurately target oxygenation during postnatal transition period.
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Frequência Cardíaca , Lactente Extremamente Prematuro , Oximetria , Saturação de Oxigênio , Humanos , Recém-Nascido , Frequência Cardíaca/fisiologia , Saturação de Oxigênio/fisiologia , Feminino , Masculino , Oximetria/métodos , Valores de Referência , Espectroscopia de Luz Próxima ao Infravermelho , Recém-Nascido Prematuro , Oxigênio/metabolismo , Oxigênio/sangue , Encéfalo/metabolismo , Idade GestacionalRESUMO
Neonatology is a pediatric sub-discipline focused on providing care for newborn infants, including healthy newborns, those born prematurely, and those who present with illnesses or malformations requiring medical care. The European Training Requirements (ETR) in Neonatology provide a framework for standardized quality and recognition of equality of training throughout Europe. The latest ETR version was approved by the Union of European Medical Specialists (UEMS) in April 2021. Here, we present the curriculum of the European School of Neonatology Master of Advanced Studies (ESN MAS), which is based on the ETR in Neonatology and aims to provide a model for effective and standardized training and education in neonatal medicine. We review the history and theory that form the foundation of contemporary medical education and training, provide a literature review on best practices for medical training, pediatric training, and neonatology training specifically, including educational frameworks and evidence-based systems of evaluation. The ESN MAS Curriculum is then evaluated in light of these best practices to define its role in meeting the need for a standardized empirically supported neonatology training curriculum for physicians, and in the future for nurses, to improve the quality of neonatal care for all infants. IMPACT STATEMENT: A review of the neonatology training literature was conducted, which concluded that there is a need for standardized neonatology training across international contexts to keep pace with growth in the field and rapidly advancing technology. This article presents the European School of Neonatology Master of Advanced Studies in Neonatology, which is intended to provide a standardized training curriculum for pediatricians and nurses seeking sub-specialization in neonatology. The curriculum is evaluated in light of best practices in medical education, neonatology training, and adult learning theory.
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BACKGROUND: Training and assessment of operator competence for the less invasive surfactant administration (LISA) procedure vary. This study aimed to obtain international expert consensus on LISA training (LISA curriculum (LISA-CUR)) and assessment (LISA assessment tool (LISA-AT)). METHODS: From February to July 2022, an international three-round Delphi process gathered opinions from LISA experts (researchers, curriculum developers, and clinical educators) on a list of items to be included in a LISA-CUR and LISA-AT (Round 1). The experts rated the importance of each item (Round 2). Items supported by more than 80% consensus were included. All experts were asked to approve or reject the final LISA-CUR and LISA-AT (Round 3). RESULTS: A total of 153 experts from 14 countries participated in Round 1, and the response rate for Rounds 2 and 3 was >80%. Round 1 identified 44 items for LISA-CUR and 22 for LISA-AT. Round 2 excluded 15 items for the LISA-CUR and 7 items for the LISA-AT. Round 3 resulted in a strong consensus (99-100%) for the final 29 items for the LISA-CUR and 15 items for the LISA-AT. CONCLUSIONS: This Delphi process established an international consensus on a training curriculum and content evidence for the assessment of LISA competence. IMPACT: This international consensus-based expert statement provides content on a curriculum for the less invasive surfactant administration procedure (LISA-CUR) that may be partnered with existing evidence-based strategies to optimize and standardize LISA training in the future. This international consensus-based expert statement also provides content on an assessment tool for the LISA procedure (LISA-AT) that can help to evaluate competence in LISA operators. The proposed LISA-AT enables standardized, continuous feedback and assessment until achieving proficiency.
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Competência Clínica , Tensoativos , Técnica Delphi , Currículo , ConsensoRESUMO
Neonatal venous thrombosis is a rare condition that can be iatrogenic or occur due to viral infections or genetic mutations. Thromboembolic complications are also commonly observed as a result of SARS-CoV-2 infections. They can affect pediatric patients, especially the ones suffering from multisystem inflammatory syndrome in children (MIS-C) or multisystem inflammatory syndrome in neonates (MIS-N). The question remains whether the maternal SARS-CoV-2 infection during pregnancy can lead to thromboembolic complications in fetuses and neonates. We report on a patient born with an embolism in the arterial duct, left pulmonary artery, and pulmonary trunk, who presented several characteristic features of MIS-N, suspecting that the cause might have been the maternal SARS-CoV2 infection in late pregnancy. Multiple genetic and laboratory tests were performed. The neonate presented only with a positive result of IgG antibodies against SARS-CoV-2. He was treated with low molecular weight heparin. Subsequent echocardiographic tests showed that the embolism dissolved. More research is necessary to evaluate the possible neonatal complications of maternal SARS-CoV-2 infection.
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COVID-19 , Canal Arterial , Complicações Infecciosas na Gravidez , Trombose Venosa , Masculino , Recém-Nascido , Feminino , Gravidez , Humanos , Criança , RNA Viral , COVID-19/complicações , SARS-CoV-2 , Trombose Venosa/tratamento farmacológico , Trombose Venosa/etiologia , Parto , VitaminasRESUMO
AIMS: The aim of this study was to examine the potential association of family-centred care as perceived by parents during a NICU stay with parents' depressive symptoms at discharge and at 4 months corrected for infant age. DESIGN: A longitudinal, multicentre cohort study was conducted from 2018 to 2020 in 23 NICUs across 15 countries. METHODS: Parents (n = 635 mothers, n = 466, fathers) of infants (n = 739) born before 35 weeks of gestation and admitted to the participating NICUs were enrolled to the study during the first weeks of their infants' hospitalizations. They responded to Digi-FCC daily text messages inquiring about their perception of family-centred care provided by NICU staff. In addition, they completed a questionnaire assessing their overall perception of family-centred care at discharge. Parents' depressive symptoms were measured by the Edinburgh Postnatal Depression Scale at discharge and again after discharge when their infants were at 4 months corrected for age. RESULTS: The mothers' and the fathers' perceptions of family-centred care were associated with their depressive symptoms at discharge and at 4 months corrected age, controlling for gestational age, multiple birth, parent education and relationship status. Parents' participation in infant care, care-related decisions and emotional support provided to parents by staff explained the variation in the parents' perceptions of family-centred care. The factors facilitating the implementation of family-centred care included unlimited access to the unit for the parents and for their significant others, as well as amenities for parents. CONCLUSIONS: Our study shows that family-centred NICU care associates with parents' depressive symptoms after a NICU stay. IMPACT: Depression is common in parents of preterm infants. The provision of family-centred care may protect the mental well-being of parents of preterm infants.
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Unidades de Terapia Intensiva Neonatal , Alta do Paciente , Estudos de Coortes , Depressão , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Pais/psicologiaRESUMO
OBJECTIVE: The aim of this study is to evaluate the ability of the Newborn Infant Parasympathetic Evaluation (NIPE) index to detect the response to nociceptive stimuli in nonanesthetized infants and to compare these results to simultaneous scoring by behavioral scales. STUDY DESIGN: Thirty-six nonanesthetized infants admitted to neonatal/pediatric intensive care unit (N/PICUs) were enrolled to the study. Due to faulty records of the data, three patients had to be excluded. To detect pain caused by noxious stimuli, the heart-rate-variability-derived NIPE index and behavioral pain scales designed for measuring procedural pain in nonverbal children were used. RESULTS: Forty-one painful events were available for analysis. We observed in the whole group a statistically significant decrease in NIPE values at 1, 2, and 3 minutes after a painful stimulus, in comparison to the NIPE value at rest and the statistically significant differences between the minimum NIPE value within 3 minutes after the stimulus in comparison to NIPE value at rest in the whole group, as well as in the subgroups of moderate and severe pain. Receiver operating characteristic (ROC) analysis has shown the strong sensitivity and specificity of the NIPE in detecting the noxious stimuli (ROC AUC: 0.767). We also found that the stronger the sensation of pain was, the more rapidly NIPE reached its lowest value. DISCUSSION: Our study indicates that the painful procedures are associated with a significant decrease in the NIPE value within 3 minutes after a noxious stimulus. Based on our observation, the minimum value within 3 minutes from the painful procedure seems to be the most distinctive value.
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Medição da Dor/métodos , Dor Processual/diagnóstico , Feminino , Frequência Cardíaca , Humanos , Lactente , Recém-Nascido , Masculino , Projetos Piloto , Estudos Prospectivos , Curva ROC , Sensibilidade e EspecificidadeRESUMO
INTRODUCTION: The objective of this study was to elucidate the efficacy of long-term amnioinfusion on perinatal outcomes in patients with preterm premature rupture of membranes (PPROM) before 26 weeks' gestation. MATERIAL: A total of 31 patients with PPROM at a periviable gestational age (21 + 0-25 + 0 weeks) were enrolled. Long-term amnioinfusion was performed in 22 patients, and 9 patients did not receive amnioinfusion. Data were collected retrospectively from 2 clinical sites between January 2017 and March 2019. RESULTS: In the medical management group, there was a significantly higher rate of chorioamnionitis compared to the long-term amnioinfusion group (89 vs. 15%, p = 0.001). The latency period between PPROM and delivery was higher in the amnioinfusion group (median, 5.5 vs. 3 weeks, p = 0.04). The frequency of bronchopulmonary dysplasia was higher in the control group compared to the amnioinfusion group (89 vs. 40%, p = 0.03). The rates of other neonatal complications were similar in both groups. CONCLUSIONS: Long-term amnioinfusion through an intrauterine catheter in PPROM before 26 weeks' gestation may improve pregnancy and newborn outcomes.
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Ruptura Prematura de Membranas Fetais , Resultado da Gravidez , Catéteres , Parto Obstétrico , Feminino , Ruptura Prematura de Membranas Fetais/terapia , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Gravidez , Estudos RetrospectivosRESUMO
The European Resuscitation Council has produced these newborn life support guidelines, which are based on the International Liaison Committee on Resuscitation (ILCOR) 2020 Consensus on Science and Treatment Recommendations (CoSTR) for Neonatal Life Support. The guidelines cover the management of the term and preterm infant. The topics covered include an algorithm to aid a logical approach to resuscitation of the newborn, factors before delivery, training and education, thermal control, management of the umbilical cord after birth, initial assessment and categorisation of the newborn infant, airway and breathing and circulation support, communication with parents, considerations when withholding and discontinuing support.
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BACKGROUND: Alveolar capillary dysplasia (ACD) is a rare cause of severe pulmonary hypertension and respiratory failure in neonates. The onset of ACD is usually preceded by a short asymptomatic period. The condition is refractory to all available therapies as it irreversibly affects development of the capillary bed in the lungs. The diagnosis of ACD is based on histopathological evaluation of lung biopsy or autopsy tissue or genetic testing of FOXF1 on chromosome 16q24.1. Here, we describe the first two Polish patients with ACD confirmed by histopathological and genetic examination. CASE PRESENTATION: The patients were term neonates with high Apgar scores in the first minutes of life. They both were diagnosed prenatally with heart defects. Additionally, the first patient presented with omphalocele. The neonate slightly deteriorated around 12th hour of life, but underwent surgical repair of omphalocele followed by mechanical ventilation. Due to further deterioration, therapy included inhaled nitric oxide (iNO), inotropes and surfactant administration. The second patient was treated with prostaglandin E1 since birth due to suspicion of aortic coarctation (CoA). After ruling out CoA in the 3rd day of life, infusion of prostaglandin E1 was discountinued and immediately patient's condition worsened. Subsequent treatment included re-administration of prostaglandin E1, iNO and mechanical ventilation. Both patients presented with transient improvement after application of iNO, but died despite maximized therapy. They were histopathologically diagnosed post-mortem with ACD. Array comparative genomic hybridization in patient one and patient two revealed copy-number variant (CNV) deletions, respectively, ~ 1.45 Mb in size involving FOXF1 and an ~ 0.7 Mb in size involving FOXF1 enhancer and leaving FOXF1 intact. CONCLUSIONS: Both patients presented with a distinct course of ACD, extra-pulmonary manifestations and response to medications. Surgery and ceasing of prostaglandin E1 infusion should be considered as potential causes of this variability. We further highlight the necessity of thorough genetic testing and histopathological examination and propose immunostaining for CD31 and CD34 to facilitate the diagnostic process for better management of infants with ACD.
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Fatores de Transcrição Forkhead , Hibridização Genômica Comparativa , Fatores de Transcrição Forkhead/genética , Estudos de Associação Genética , Humanos , Lactente , Recém-Nascido , Síndrome da Persistência do Padrão de Circulação Fetal , Polônia , Alvéolos Pulmonares/anormalidadesRESUMO
OBJECTIVE: The aim of the study was to assess the influence of mechanical ventilation with helium-oxygen mixture (heliox) on basic vital signs, oxygenation, acid-base balance and respiratory mechanics in newborns with respiratory distress syndrome (RDS), previously treated with surfactant. MATERIAL AND METHODS: The study was carried out in preterm newborns with respiratory failure requiring mechanical ventilation due to RDS, requiring Fi02>0.4 after a single dose of surfactant. Patients were ventilated using PC-SIMV Parameters of mechanical ventilation, respiratory function, oxygenation, acid-base balance and vital signs were recorded at baseline, one hour during and one hour after heliox ventilation. RESULTS: Ten newborns with RDS were enrolled in the study Mechanical ventilation with heliox did not affect vital signs and patient general condition remained stable during and after ventilation with heliox. Mechanical ventilation with heliox was associated with a statistically significant increase in tidal volume (mean 5.48 vs. 6.55 ml/kg). There were no significant changes in minute ventilation and peak expiratory flow rate. Mechanical ventilation with heliox allowed the use of significantly lower fractions of inspired oxygen (mean 0.55 vs. 0.35), with a significant decrease in the oxygenation index (mean 8.77 vs. 5.02) and alveolar-arterial oxygen tension difference (mean 263.81 vs. 113.28 mm Hg). After ventilation with this gas mixture was stopped, the patients required higher Fi02, 01 and AaD02 levels increased. CONCLUSIONS: Mechanical ventilation with heliox was safe, improved oxygenation and caused an increase in tidai, volume in newborns with RDS previously treated with surfactant.
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Equilíbrio Ácido-Base/efeitos dos fármacos , Hélio/administração & dosagem , Oxigênio/administração & dosagem , Respiração Artificial/métodos , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Administração por Inalação , Terapia Combinada , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Resultado do Tratamento , Sinais Vitais/efeitos dos fármacosRESUMO
INTRODUCTION: The European Union stipulates transnational recognition of professional qualifications for several sectoral professions, including medical doctors. The Union of European Medical Specialists (UEMS), in its "Charter on Training of Medical Specialists," defines the principles for high-level medical training. These principles are manifested in the framework for European Training Requirements (ETR), ensuring medical training reflects modern medical practice and current scientific findings. In 1998, the European Society for Paediatric Research developed the first ETR for Neonatology. We present the ETR Neonatology in its third iteration (ETR III), ratified by the European Academy of Paediatrics (EAP), and approved by UEMS in 2021. METHODS: In generating the ETR III, existing European policy documents on training requirements, including national syllabi and the European Standards of Care for Newborn Health were considered. To ensure the ETR III meets a pan-European standard of expertise in Neonatology, input from representatives from 27 European national paediatric/neonatal societies, and a European parent organisation, was sought. RESULTS: The ETR III summarises the requirements of contemporary training programs in Neonatology and offers a system for accrediting trainers and training centres. We describe the content of the ETR III training syllabus and means of gaining and assessing competency as a medical care provider in Neonatology. CONCLUSION: Graduates of courses following the ETR III Neonatology will obtain a certificate of satisfactory training completion which should be accepted by all European member states as a baseline qualification to practice as a specialist in neonatal medicine, enabling mutual recognition of status throughout Europe.
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União Europeia , Neonatologia , Neonatologia/educação , Neonatologia/normas , Humanos , Europa (Continente) , Acreditação/normas , Recém-Nascido , Sociedades Médicas , Currículo , Competência ClínicaRESUMO
OBJECTIVE: To evaluate the performance (i.e., agreement between set and measured parameters) and safety (adverse events, device malfunctions, and ventilator alarms) of the fabian HFOi neonatal ventilator in volume guaranteed (VG) mode during conventional ventilation. To analyze the impact of leakage around the endotracheal tube and the set maximum allowed inflating pressure (Pmax). DESIGN: Prospective multicenter observational study. METHODS: Clinical and ventilator data were collected from 71 infants receiving VG ventilation for ≥12 h in four neonatal intensive care units (NICUs). Ventilator settings, parameters, and alarms were downloaded with 0.5 Hz sampling rate. RESULTS: Data from 4,341 h of ventilation were analyzed. The median (interquartile range, IQR) of the absolute difference between the target and measured expired tidal volume was 0.76 (0.51-1.16) mL/kg. It was less when leak was <50% (median 0.36, IQR: 0.25-0.64 mL/kg, p < .001) and even less when the required peak inflating pressure (PIP) was also below Pmax (median: 0.09 mL/kg, IQR: 0.00-0.16 mL/kg, p < .001). On NICUs setting Pmax higher, tidal volume was maintained significantly closer to target. In 56 patients VG was continued until extubation. Two ventilator malfunctions were reported, none of them resulting in patient harm. "Tidal volume not reached" alarm occurred 32 times hourly, usually lasting for <10 s. CONCLUSION: The fabian HFOi ventilator maintains tidal volume close to its target, particularly when leak is <50% and when PIP is below Pmax. In most patients VG can be continued until extubation. Despite frequent ventilator alarms, ventilator malfunctions occur very rarely.
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INTRODUCTION: Simulation-based training (SBT) aids healthcare providers in acquiring the technical skills necessary to improve patient outcomes and safety. However, since SBT may require significant resources, training all skills to a comparable extent is impractical. Hence, a strategic prioritization of technical skills is necessary. While the European Training Requirements in Neonatology provide guidance on necessary skills, they lack prioritization. We aimed to identify and prioritize technical skills for a SBT curriculum in neonatology. METHODS: A three-round modified Delphi process of expert neonatologists and neonatal trainees was performed. In round one, the participants listed all the technical skills newly trained neonatologists should master. The content analysis excluded duplicates and non-technical skills. In round two, the Copenhagen Academy for Medical Education and Simulation Needs Assessment Formula (CAMES-NAF) was used to preliminarily prioritize the technical skills according to frequency, importance of competency, SBT impact on patient safety, and feasibility for SBT. In round three, the participants further refined and reprioritized the technical skills. Items achieving consensus (agreement of ≥75%) were included. RESULTS: We included 168 participants from 10 European countries. The response rates in rounds two and three were 80% (135/168) and 87% (117/135), respectively. In round one, the participants suggested 1964 different items. Content analysis revealed 81 unique technical skills prioritized in round two. In round three, 39 technical skills achieved consensus and were included. CONCLUSION: We reached a European consensus on a prioritized list of 39 technical skills to be included in a SBT curriculum in neonatology.
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Competência Clínica , Currículo , Técnica Delphi , Neonatologia , Treinamento por Simulação , Neonatologia/educação , Humanos , Europa (Continente) , Treinamento por Simulação/métodos , Feminino , Masculino , AdultoRESUMO
OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.
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Estudos Cross-Over , Unidades de Terapia Intensiva Neonatal , Saturação de Oxigênio , Humanos , Recém-Nascido , Feminino , Masculino , Hipóxia , Hiperóxia/prevenção & controle , Oxigênio/sangue , Oxigênio/administração & dosagem , Oximetria/métodos , Oxigenoterapia/métodos , Oxigenoterapia/efeitos adversos , Oxigenoterapia/instrumentação , Respiração Artificial/efeitos adversos , Recém-Nascido PrematuroRESUMO
OBJECTIVE: Regarding the use of lung ultrasound (LU) in neonatal intensive care units (NICUs) across Europe, to assess how widely it is used, for what indications and how its implementation might be improved. DESIGN AND INTERVENTION: International online survey. RESULTS: Replies were received from 560 NICUs in 24 countries between January and May 2023. LU uptake varied considerably (20%-98% of NICUs) between countries. In 428 units (76%), LU was used for clinical indications, while 34 units (6%) only used it for research purposes. One-third of units had <2 years of experience, and only 71 units (13%) had >5 years of experience. LU was mainly performed by neonatologists. LU was most frequently used to diagnose respiratory diseases (68%), to evaluate an infant experiencing acute clinical deterioration (53%) and to guide surfactant treatment (39%). The main pathologies diagnosed by LU were pleural effusion, pneumothorax, transient tachypnoea of the newborn and respiratory distress syndrome. The main barriers for implementation were lack of experience with technical aspects and/or image interpretation. Most units indicated that specific courses and an international guideline on neonatal LU could promote uptake of this technique. CONCLUSIONS: Although LU has been adopted in neonatal care in most European countries, the uptake is highly variable. The main indications are diagnosis of lung disease, evaluation of acute clinical deterioration and guidance of surfactant. Implementation may be improved by developing courses and publishing an international guideline.
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Unidades de Terapia Intensiva Neonatal , Pulmão , Ultrassonografia , Humanos , Recém-Nascido , Europa (Continente) , Ultrassonografia/métodos , Pulmão/diagnóstico por imagem , Inquéritos e Questionários , Síndrome do Desconforto Respiratório do Recém-Nascido/diagnóstico por imagem , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Padrões de Prática Médica/estatística & dados numéricosRESUMO
Importance: Red blood cell (RBC) transfusions are frequently administered to preterm infants born before 32 weeks of gestation in the neonatal intensive care unit (NICU). Two randomized clinical trials (Effects of Transfusion Thresholds on Neurocognitive Outcomes of Extremely Low-Birth-Weight Infants [ETTNO] and Transfusion of Prematures [TOP]) found that liberal RBC transfusion thresholds are nonsuperior to restrictive thresholds, but the extent to which these results have been integrated into clinical practice since publication in 2020 is unknown. Objective: To describe neonatal RBC transfusion practice in Europe. Design, Setting, and Participants: This international prospective observational cohort study collected data between September 1, 2022, and August 31, 2023, with a 6-week observation period per center, from 64 NICUs in 22 European countries. Participants included 1143 preterm infants born before 32 weeks of gestation. Exposure: Admission to the NICU. Main Outcomes and Measures: Study outcome measures included RBC transfusion prevalence rates, cumulative incidence, indications, pretransfusion hemoglobin (Hb) levels, volumes, and transfusion rates, Hb increment, and adverse effects of RBC transfusion. Results: A total of 1143 preterm infants were included (641 male [56.1%]; median gestational age at birth, 28 weeks plus 2 days [IQR, 26 weeks plus 2 days to 30 weeks plus 2 days]; median birth weight, 1030 [IQR, 780-1350] g), of whom 396 received 1 or more RBC transfusions, totaling 903 transfusions. Overall RBC transfusion prevalence rate during postnatal days 1 to 28 was 3.4 transfusion days per 100 admission days, with considerable variation across countries, only partly explained by patient mix. By day 28, 36.5% (95% CI, 31.6%-41.5%) of infants had received at least 1 transfusion. Most transfusions were given based on a defined Hb threshold (748 [82.8%]). Hemoglobin levels before transfusions indicated for threshold were below the restrictive thresholds set by ETTNO in 324 of 729 transfusions (44.4%) and TOP in 265 of 729 (36.4%). Conversely, they were between restrictive and liberal thresholds in 352 (48.3%) and 409 (56.1%) transfusions, respectively, and above liberal thresholds in 53 (7.3%) and 55 (7.5%) transfusions, respectively. Most transfusions given based on threshold had volumes of 15 mL/kg (470 of 738 [63.7%]) and were administered over 3 hours (400 of 738 [54.2%]), but there was substantial variation in dose and duration. Conclusions and Relevance: In this cohort study of very preterm infants, most transfusions indicated for threshold were given for pretransfusion Hb levels above restrictive transfusion thresholds evaluated in recent trials. These results underline the need to optimize practices and for implementation research to support uptake of evidence.
Assuntos
Transfusão de Eritrócitos , Unidades de Terapia Intensiva Neonatal , Humanos , Transfusão de Eritrócitos/estatística & dados numéricos , Transfusão de Eritrócitos/métodos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Europa (Continente) , Estudos Prospectivos , Feminino , Masculino , Recém-Nascido PrematuroRESUMO
INTRODUCTION: Congenital pulmonary airway malformations (CPAMs) are rare sporadic lesions frequently associated with poor fetal prognosis. Type 3 CPAMs are characterized by small hyperechogenic cysts (<5 mm). Hydrops often develops secondarily, and the fetal survival rate is approximately 5% in this setting. CASE PRESENTATION: We present a case of a large type 3 CPAM complicated by fetal hydrops. The lesion was detected at 19 gestational weeks (GW) and confirmed by fetal MRI at 29 GW. At 22 GW, a course of maternal steroids was given as a possible treatment of type 3 CPAM. Peritoneal-amniotic shunt was placed twice to reduce fetal ascites, with unsatisfactory results. Similarly, polyhydramnios was relieved by two amnioreductions, but redeveloped soon after. A baby girl was delivered spontaneously at 33 GW and received a two-stage partial lobectomy in the first three months of life. Desaturations necessitated challenging invasive oscillatory ventilation between stages. Her outcome is unexpectedly positive and she may expect a good quality of life. She now approaches one year of age, with near-to-normal growth and developmental milestones. DISCUSSION: Type 3 CPAMs complicated by fetal hydrops are associated with high perinatal mortality. While open fetal surgery remains a viable option in select specialist centers, antenatal interventions are typically ineffective. The survival of this infant can be attributed to prenatal management and early postnatal surgical intervention. The lack of guidelines for ventilation in this setting was a significant challenge for neonatal intensivists. Multidisciplinary vigilance and collaboration with frequent specialist follow ups were the key to success for both mother and child.