Transcatheter closure is becoming the standard of care for definitive closure of patent ductus arteriosus (PDA) in premature infants. To avoid risks associated with the transportation of a fragile neonate, the intervention can be performed as a bedside procedure within the neonatal intensive care unit, even in extremely low birth weight (ELBW) infants. Limited evidence-based guidelines are available for transcatheter PDA closure in premature infants in general and for bedside PDA closure specifically. This framework represents an expert consensus regarding bedside PDA closure in ELBW infants and guidance for procedural implementation. Recommendations for patient eligibility, pre-procedural planning, staff requirements, procedural aspects, imaging and follow-up and a stepwise implementation plan for a bedside PDA closure program are presented. IMPACT: Extremely low birth weight (ELBW) infants with a patent ductus arteriosus (PDA) may be considered for transcatheter PDA closure. An expert consensus is provided on bedside transcatheter PDA closure performed within the neonatology intensive care unit, thereby mitigating the risks associated with transportation of these highly vulnerable infants outside of the neonatology intensive care unit. Guidance is provided regarding procedural aspects, including staff requirements, planning, setting, and imaging, and implementation of a bedside transcatheter PDA closure program.
OBJECTIVE:To evaluate the influence of mode of delivery on repolarisation and QT interval in the neonatal electrocardiogram (ECG). STUDY DESIGN:KUNO-Kids is a prospective, population-based birth cohort study. Neonates received an ECG within the first week of life; subgroups were divided according to mode of delivery. Effects on neonatal QT interval were tested by linear and logistic regression analyses, adjusting for age at ECG recording. RESULTS:In total, 712 neonates were included. The primary caesarean section group showed a significant higher mean QTc (regression coefficient 6.03, p = 0.033) and a significantly increased rate of prolonged QTc >450 ms (odds ratio 2.4, p = 0.042), compared to the spontaneous delivery group. CONCLUSION:The mode of delivery has a significant effect on neonatal QTc. Clinicians should consider this influence when deciding on postnatal and follow-up examinations, regarding additional risk factors for acquired long QT interval.
OBJECTIVES:Very preterm infants may display poor postnatal growth despite receiving recommended enteral intakes. This has been linked to transient exocrine pancreatic insufficiency, indicated by low fecal pancreatic elastase-1 (FPE-1) concentrations. We aimed to determine whether growth velocity may be improved by exogenous digestive enzyme replacement. METHODS:In this bicentric prospective observational study, changes in growth velocity were assessed in very preterm infants (<32 weeks gestational age, <1500 g birth weight) with low FPE-1 concentrations (<200 µg/g). Infants received 350 U lipase from Rhizopus oryzae and 5.4 U protease from Aspergillus oryzae with every meal via gavage; the dosage was doubled once infants reached 1000 g. Average daily weight gain relative to body weight was compared during the 14 days preceding initiation of digestive enzyme replacement and during the first 14 days thereafter. RESULTS:In 71 infants (median [interquartile range] birth weight 700 [570-980] g, gestational age 25.4 [24.4-28.4] weeks) born between March 1, 2022, and December 31, 2023, daily weight gain increased from 14.7 [7.3-19.7] to 19.5 [15.7-24.0] g/kg/d (p < 0.001), relative daily weight gain per kg protein fed from 4.0 [2.0-5.9] to 5.4 [4.4-6.5] g/kg (p < 0.001), and relative daily weight gain per kcal fed from 0.11 [0.06-0.16] to 0.15 [0.13-0.19] g/kcal/d (p < 0.001). Effects were non-significant in infants fed raw milk but marked in those who received pasteurized mother's own milk or donor milk. CONCLUSION:Administration of exogenous digestive enzymes was associated with increased weight gain in very preterm infants with transient exocrine pancreatic insufficiency.
Preterm birth increases the risk of neurodevelopmental impairments, emphasizing the need for early interventions. This study aimed to assess the feasibility and effectiveness of a General Movement (GM)-based intervention on infant neurodevelopment and parental mental health. In a prospective, randomized-controlled trial, very preterm infants (gestational age <32 weeks or birth weight <1500 g) were enrolled between October 1, 2021, and June 6, 2023. Infants received a three times daily GM-based treatment by trained parents over 10 weeks starting at 34 weeks PMA or standard care. Primary outcome was neurodevelopment until 2 years’ corrected age, secondary outcomes included parental mental health and serum levels of brain damage biomarkers. Sixty-six infants were randomized (32 control, 34 intervention). The median birth weight was 1243 g (IQR, 919-1623 g) in the control group and 1035 g (IQR, 853-1230 g) in the GM group. No significant group differences were observed for neurodevelopment outcome and parental mental health. Interestingly, all three infants displaying poor neuromotor features in the intervention group before treatment showed good neurodevelopment in the follow-up. Our findings suggest a potential role of GM-based intervention in high-risk preterm infants. Future research should focus on improved participant selection and adherence.
Despite medical advancements, the rate of premature births remains at one in ten babies worldwide. Moderate and late preterm (MLPT, gestational age 32–36 weeks) infants constitute 80
BACKGROUND:In infants, pulmonary hypertension (PH) increases morbidity and mortality. Echocardiography, though standard, is time- and expertise-demanding. We propose a deep learning approach for automated PH detection using standard echocardiography videos, validated by the systolic eccentricity index (EIs). METHODS:The training and validation set comprised 975 videos and the held-out set 378 videos, including five echocardiographic standard views from infants aged 3-90 days, taken between 2018-2021 and 2021-2022, respectively. Echocardiograms were labeled as PH (EIs < 0.82) and healthy (EIs ≥ 0.87). After preprocessing and random segmentation of all videos into 13.530 frames, spatial and spatio-temporal convolutional neural network architectures were used for training of a PH prediction model and gradient-weighted class activation mapping for explainability. RESULTS:The best single-view performance was achieved using parasternal short axis view (AUROC spatial and spatio-temporal: 0.91 and 0.94 in validation set, 0.93 and 0.88 in held-out set, respectively). Combination of three standard views improved accuracy with AUROC 0.96 and 0.90 in validation (spatio-temporal) and held-out set (spatial), respectively. Saliency maps revealed model focus on clinically relevant regions, including interventricular septum and left atrial filling. CONCLUSIONS:The presented deep learning model for automated detection of PH in neonates shows high accuracy, explainability, and reproducibility. IMPACT:This study presents a deep learning model that enables accurate, automated detection of pulmonary hypertension in infants using standard echocardiography videos, enhanced and evaluated with eccentricity index, an established and prognostically relevant echocardiographic parameter. The parasternal short-axis view showed the best single-view performance, combined views further improved accuracy. Explainability through saliency maps supports clinical acceptance, highlighting physiologically relevant regions in the decision process. It adds novel evidence to the literature, demonstrating the utility of spatio-temporal convolutional neural networks for early, non-invasive diagnosis. The model provides a scalable and reproducible tool for routine PH screening, potentially improving early detection and outcomes.
BackgroundNeonatal jaundice affects more than half of neonates. As bilirubin values usually peak few days after hospital discharge, jaundice remains a leading cause of rehospitalization. The recently developed BiliPredics algorithm, integrated in the first CE-approved bilirubin prediction tool, predicts individual bilirubin progression for up to 60 h into the future. Goal of the prospective study was to assess accuracy of this algorithm in predicting individual bilirubin prior to hospital discharge in neonates.MethodsA prospective multi-center study was conducted in 2021 at the University Children's Hospitals in Tübingen and Regensburg, Germany. Various scenarios differing in type and number of bilirubin measurements and in prediction horizon were tested. Primary objective was prediction accuracy of the BiliPredics algorithm based on total serum bilirubin (TSB) measurements or based on transcutaneous bilirubin (TcB) measurements alone. Secondary objective was prediction accuracy based on combinations of TSB and TcB measurements. For assessment of accuracy, two validation metrics, absolute prediction error (aPE) and relative prediction error (rPE), and two clinical acceptance conditions, margin of error of the 95%-confidence interval (95%-CI) and percentage of clinically relevant mis-predictions defined as aPE>85μmol/L, were investigated.ResultsOut of 455 enrolled neonates, 276 neonates met bilirubin inclusion criteria and were included in the analyses. Irrespective from tested prediction horizons, median rPE was small (8.5% to 9.5%) utilizing TSB measurements for up to 30 and 60 h and slightly higher (13.8%) utilizing TcB measurements for up to 48 h. The same applied for median aPE. Both clinical acceptance conditions were fulfilled across tested scenarios. Results for combined TSB-TcB scenarios up to a prediction horizon of 48 h without adjustment for type of measurement were comparable to TSB and TcB scenarios fulfilling both clinical acceptance conditions.ConclusionResults from this prospective study in neonates confirm that the BiliPredics algorithm accurately predicts bilirubin progression up to 60 h with TSB measurements and up to 48 h with TcB or combined TSB-TcB measurements. As such, prediction tools utilizing this algorithm are expected to facilitate and safely optimize jaundice risk assessment at hospital discharge with the potential to reduce jaundice-related rehospitalizations.
OBJECTIVES:This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of motor interventions initiated prior hospital discharge to prevent neurodevelopmental and motor impairment in preterm infants compared to standard care, post-discharge motor interventions, and different modalities of the same motor intervention.
BackgroundAppendicitis is a common condition among children and adolescents. Machine learning models can offer much-needed tools for improved diagnosis, severity assessment and management guidance for pediatric appendicitis. However, to be adopted in practice, such systems must be reliable, safe and robust across various medical contexts, e.g., hospitals with distinct clinical practices and patient populations.MethodsWe performed external validation of models predicting the diagnosis, management and severity of pediatric appendicitis. Trained on a cohort of 430 patients admitted to the Children’s Hospital St. Hedwig (Regensburg, Germany), the models were validated on an independent cohort of 301 patients from the Florence-Nightingale-Hospital (Düsseldorf, Germany). The data included demographic, clinical, scoring, laboratory and ultrasound parameters. In addition, we explored the benefits of model retraining and inspected variable importance.ResultsThe distributions of most parameters differed between the datasets. Consequently, we saw a decrease in predictive performance for diagnosis, management and severity across most metrics. After retraining with a portion of external data, we observed gains in performance, which, nonetheless, remained lower than in the original study. Notably, the most important variables were consistent across the datasets.ConclusionsWhile the performance of transferred models was satisfactory, it remained lower than on the original data. This study demonstrates challenges in transferring models between hospitals, especially when clinical practice and demographics differ or in the presence of externalities such as pandemics. We also highlight the limitations of retraining as a potential remedy since it could not restore predictive performance to the initial level.
Purpose: In 2020, a lockdown due to COVID-19 was ordered by the German government, resulting in population-wide restrictions. In this retrospective study, we question the extent to which health policy restrictions have influenced medical diagnoses. Methods: The incidence rates of relevant pregnancy complications during all trimesters of pregnancy were evaluated for a 6-month pre-pandemic period (April–September 2019), in comparison to the same period during the lockdown in 2020. Mothers and newborns who presented at the University Hospital St. Hedwig, Regensburg, Germany, were included in the study. The incidence rates of preeclampsia and suspected FGR (fetal growth retardation), as relevant obstetric diseases, were further compared with those in a post-pandemic period (April–September 2023). Results: A total of 5137 newborns were included, with 1709 born during the 6-month pre-pandemic period, 1806 during the 6-month lockdown period and 1687 during the 6-month post-pandemic period. During the pandemic period, significantly fewer patients were hospitalized due to hyperemesis gravidarum (1.8% vs. 0.9%, p = 0.04). No differences were observed concerning the incidence of miscarriages before and after 14 weeks of gestation (WG), preterm deliveries (<37 WG), gestational age at preterm birth and birth weight. Likewise, within the group of preterm-born babies, no difference was observed in preeclampsia among the two periods. However, in the pandemic period, the frequency of preterm-born babies with suspected FGR was significantly lower than in the pre-pandemic period (1.5% and 0.6%, p = 0.01). Regarding this point, we analyzed data of all newborns in a comparative post-pandemic period in 2023 (n = 1687). This group presented a significantly increased FGR incidence compared to that during the pandemic, therefore returning to the pre-pandemic level (1.5% and 1.4%, p = 0.145). Conclusions: During the COVID-19 pandemic, there were significantly fewer deliveries with suspected FGR. After all specific restrictions on elective and outpatient services were lifted, the incidence of suspected FGR returned to its initial level, suggesting that the diagnosis—as a solely machine-dependent and not symptom-based diagnosis—was partly exaggerated in both the pre-and post-pandemic periods.
Pulmonary hypertension (PH) in newborns is a critical condition characterized by elevated pressure in the pulmonary arteries, leading to right ventricular strain and heart failure. While right heart catheterization (RHC) is the diagnostic gold standard, echocardiography is preferred due to its non-invasive nature, safety, and accessibility. However, its accuracy highly depends on the operator, making PH assessment subjective. While automated detection methods have been explored, most models focus on adults and rely on single-view echocardiographic frames, limiting their performance in diagnosing PH in newborns. While multi-view echocardiography has shown promise in improving PH assessment, existing models struggle with generalizability. In this work, we employ a multi-view variational autoencoder (VAE) for PH prediction using echocardiographic videos. By leveraging the VAE framework, our model captures complex latent representations, improving feature extraction and robustness. We compare its performance against single-view and supervised learning approaches. Our results show improved generalization and classification accuracy, highlighting the effectiveness of multi-view learning for robust PH assessment in newborns.
OBJECTIVES:This is a protocol for a Cochrane Review (prototype). The objectives are as follows: The aim of this scoping review is to map the quantitative literature about in-hospital motor interventions used to reduce neurodevelopmental impairment in preterm infants. We will collate information about the features, delivery mechanisms, objectives, providers, underlying theoretical frameworks, hypothesized or reported outcomes of these interventions, and equity characteristics of the population. The goal will be to document the breadth and characteristics of available evidence and to identify gaps or areas of knowledge in the field of motor interventions. Subcategories: Identify motor interventions initiated during neonatal intensive care unit stays for preterm infants Identify techniques, elements, and modalities in each intervention Determine the theories underlying these interventions Describe the extent to which the interventions are parent-centered Synthesize and categorize the different motor interventions.
Midwives as well as medical doctors may carry out the initial examination of a newborn after birth in accordance with German health care regulation and guidelines. However, it is unclear which profession based on which qualification is performing these examinations in current clinical practice.The aim of the study was to assess which professions are carrying out the initial examinations of a newborn in the largest German maternity hospitals as of today.University maternity hospitals and maternity hospitals with more than 2000 births in 2021 were asked to anwer a webbased questionnaire. A chi-square test was used for group comparisons.77 out of 111 contacted maternity hospitals participated. In total, five different professions carry out Apgar scores and the initial neonatal examinations in a healthy newborn in the largest German maternity hospitals. In 92% of maternity hospitals, midwives regularly collect Apgar scores. In most hospitals, initial examinations of the newborn are also regularly carried out by midwives (74%), but significantly less often than Apgar scores (p≤0,001). University and non-university maternity hospitals do not differ significantly in the rate at which midwives performed Apgar scores (93.9% vs. 90.9%, p=0.623) and initial examinations of the newborn (72.7% vs. 75%, p=0.822).Midwives are the predominant medical profession carrying out initial examinations of the newborn in German maternity hospitals as of today. Thus, they should also be the primary target group for quality assurance and quality improvement measures for these examinations in in the future.
Continuous outcome measurements truncated by death present a challenge for the estimation of unbiased treatment effects in randomized controlled trials (RCTs). One way to deal with such situations is to estimate the survivor average causal effect (SACE), but this requires making nontestable assumptions. Motivated by an ongoing RCT in very preterm infants with intraventricular hemorrhage, we performed a simulation study to compare an SACE estimator with complete case analysis (CCA) and analysis after multiple imputation of missing outcomes. We set up nine scenarios combining positive, negative, and no treatment effect on the outcome (cognitive development) and on survival at 2 years of age. Treatment effect estimates from all methods were compared in terms of bias, mean squared error, and coverage with regard to two true treatment effects: the treatment effect on the outcome used in the simulation and the SACE, which was derived by simulation of both potential outcomes per patient. Despite targeting different estimands (principal stratum estimand, hypothetical estimand), the SACE-estimator and multiple imputation gave similar estimates of the treatment effect and efficiently reduced the bias compared to CCA. Also, both methods were relatively robust to omission of one covariate in the analysis, and thus violation of relevant assumptions. Although the SACE is not without controversy, we find it useful if mortality is inherent to the study population. Some degree of violation of the required assumptions is almost certain, but may be acceptable in practice.
The European Society for Paediatric Research (ESPR) first developed recommendations for a Neonatology specific European training curriculum in 1998, with updates in 2007 and 2021. The aim of these recommendations was to define a common, European standard of training for national educational programmes for Neonatologists. Following the Union of European Medical Specialists’ (UEMS) framework of European Training Requirements (ETR), and similar to the American Board of Pediatrics (ABP) recommendations, graduates of training programmes conforming to the ETR will be eligible throughout Europe for recognition of equality of training, and with that should be enabled to freedom-of-movement. This concept also accounts for neonatal specialists. We therefore present the pan-European work on the ETR Neonatology in its third iteration (ETR III), summarising the basic requirements for contemporary training programmes, trainers, and training centres in neonatology. We highlight the European School of Neonatology (ESN) as a comprehensive online educational platform which provides the theoretical and practical background to satisfy the ETR-III. Lastly, we introduce the European Board of Neonatal & Child Health Research (EBNCHR) as a committee dedicated to gaining acceptance for the concept of harmonising education and training in Neonatology and recognising Neonatology as a Paediatric subspecialty in every European Union member state.