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Background Life-threatening conditions are infrequent in children. Current literature in paediatric prehospital research is centred around trauma and paediatric out-of-hospital cardiac arrests (POHCA). The aims of this study were to (1) outline the distribution of trauma, POHCA or other medical symptoms among survivors and non-survivors after paediatric emergency calls, and (2) to investigate these clinical presentations’ association with mortality in children with and without pre-existing comorbidity, respectively. Methods Nationwide population-based cohort study including ground and helicopter emergency medical services in Denmark for six consecutive years (2016–2021). The study included all calls to the emergency number 1-1-2 regarding children ≤ 15 years (N = 121,230). Interhospital transfers were excluded, and 1,143 patients were lost to follow-up. Cox regressions were performed with trauma or medical symptoms as exposure and 7-day mortality as the outcome, stratified by ‘Comorbidity’, ‘Severe chronic comorbidity’ and ’None’ based on previous healthcare visits. Results Mortality analysis included 76,956 unique patients (median age 5 (1–12) years). Annual all-cause mortality rate was 7 per 100,000 children ≤ 15 years. For non-survivors without any pre-existing comorbidity ( n  = 121), reasons for emergency calls were trauma 18.2%, POHCA 46.3% or other medical symptoms 28.9%, whereas the distribution among the 134 non-survivors with any comorbidity was 7.5%, 27.6% and 55.2%, respectively. Compared to trauma patients, age- and sex-adjusted hazard ratio for patients with calls regarding medical symptoms besides POHCA was 0.8 [0.4;1.3] for patients without comorbidity, 1.1 [0.5;2.2] for patients with comorbidity and 6.1 [0.8;44.7] for patients with severe chronic comorbidity. Conclusion In both non-survivors with and without comorbidity, a considerable proportion of emergency calls had been made because of various medical symptoms, not because of trauma or POHCA. This outline of diagnoses and mortality following paediatric emergency calls can be used for directing paediatric in-service training in emergency medical services.

Background Prehospital vital sign documentation in paediatric patients is incomplete, especially in patients ≤ 2 years. The aim of the study was to increase vital sign registration in paediatric patients through specific educational initiatives. Methods Prospective quasi-experimental study with interrupted time-series design in the North Denmark and South Denmark regions. The study consecutively included all children aged < 18 years attended by the emergency medical service (EMS) from 1 July 2019 to 31 December 2021. Specific educational initiatives were conducted only in the North Denmark EMS and included video learning and classroom training based on the European Paediatric Advanced Life Support principles. The primary outcome was the proportion of patients who had their respiratory rate, peripheral capillary oxygen saturation, heart rate and level of consciousness recorded at least twice. We used a binomial regression model stratified by age groups to compare proportions of the primary outcome in the pre- and post-intervention periods in each region. Results In North Denmark, 7551 patients were included, while 15,585 patients from South Denmark were used as a reference. Virtually all of the North Denmark EMS providers completed the video learning (98.7%). The total study population involved patients aged ≤ 2 months (5.5%), 3–11 months (7.4%), 1–2 years (18.8%), 3–7 years (16.2%) and ≥ 8 years (52.1%). In the intervention region, the primary outcome increased from the pre- to the post-intervention period from 35.3% to 40.5% [95% CI for difference 3.0;7.4]. There were large variations in between age groups with increases from 18.8% to 27.4% [95% CI for difference 5.3;12.0] among patients aged ≤ 2 years, from 33.5% to 43.7% [95% CI for difference 4.9;15.5] among patients aged 3–7 years and an insignificant increase among patients aged ≥ 8 years (from 46.4% to 47.9% [95% CI for difference − 1.7;4.7]). In the region without the specific educational interventions, proportions were steady for all age groups throughout the entire study period. Conclusions Mandatory educational initiatives for EMS providers were associated with an increase in the extent of vital sign registration in paediatric patients ≤ 7 years. Incomplete vital registration was associated with, but not limited to non-urgent cases.

Background Around 2–6% of term or late preterm neonates receive phototherapy for hyperbilirubinemia. Standard treatment today is overhead phototherapy. A new device has been developed, the BiliCocoon, where the neonates are “wrapped” presumably making them more comfortable. The aim was to compare the efficacy and performance of the BiliCocoon with overhead LED phototherapy. Methods A randomized open-label multicenter trial in three Danish neonatal units. Healthy hyperbilirubinemic neonates, gestational age ≥33 weeks and postnatal age 24 h to 14 days were randomized to 24 hours’ of treatment with BiliCocoon or overhead blue LED phototherapy with an equal level of irradiance. A mixed effect model with random effect by center was used to compare the percentage decrease in total serum bilirubin (TSB) between the treatments. Results Totally 83 neonates were included. Mean TSB reduction in the BiliCocoon group ( N  = 42), adjusted for baseline TSB, was significantly lower than in the overhead LED group ( N  = 41), 29% vs. 38% ( p -value < 0.01). Overall difference in temperature by treatment (BiliCocoon vs overhead) was 0.70 [0.37; 1.02] °C, p -value < 0.01. Conclusion Bilirubin reducing efficacy of BiliCocoon was lower than that of overhead phototherapy, but it was sufficient for nearly all neonates during 24 hours of treatment. Impact The BiliCocoon has a bilirubin reducing efficacy, sufficient for almost all neonates during 24 hours of phototherapy. The BiliCocoon does not have an equal bilirubin reducing efficacy as overhead phototherapy. The duration of light exposure was longer for the neonates treated in the BiliCocoon. A few neonates can be exclusively breastfed in the BiliCocoon throughout the treatment. The reason for stopping breastfeeding in the BiliCocoon was most often, that the neonates developed hyperthermia.

Introduction Using pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA. Methods The NONA-LISA trial (ClinicalTrials.gov, NCT05609877) is a multicentre, blinded, randomised controlled trial aiming at including 324 infants born before 30 gestational weeks, meeting the criteria for surfactant treatment by LISA. Infants will be randomised to LISA after administration of fentanyl 0.5–1 mcg/kg intravenously (fentanyl group) or isotonic saline solution intravenously (saline group). All infants will receive standardised non-pharmacological comfort care before and during the LISA procedure. Additional analgesics will be provided at the clinician’s discretion. The primary outcome is the need for invasive ventilation, meaning mechanical or manual ventilation via an endotracheal tube, for at least 30 min (cumulated) within 24 h of the procedure. Secondary outcomes include the modified COMFORTneo score during the procedure, bronchopulmonary dysplasia at 36 weeks, and mortality at 36 weeks. Discussion The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice. Impact Pre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA). This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort. The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.

Background: We have developed a rapid method, based on lamellar body counts (LBC) on gastric aspirate, for identifying newborns who will develop respiratory distress syndrome with a need for surfactant supplementation. Objective: We set out to test whether it was possible to improve the outcome when used in a clinical trial. Methods: We randomly assigned 380 infants born at 24-29 weeks' gestation and supported with nasal continuous positive airway pressure (nCPAP) to receive surfactant guided either by LBC (intervention group) or increasing need for oxygen (control group). The primary outcome was mechanical ventilation or death within 5 days. Secondary outcomes included need for oxygen expressed by arterial to alveolar oxygen tension ratio (a/APO 2 ) at the age of 6 h and need for oxygen at day 28. Results: The primary outcomes were equal (25%) in the two groups. The intervention group had higher a/APO 2 than the control group at 6 h, median 0.64 versus 0.52 (p < 0.01), and the subgroup with gestational age 26-29 weeks needed fewer days of oxygen supplementation than the controls, median 2 vs. 9 days (p = 0.01), and fewer infants needed oxygen at day 28 (p = 0.04). Furthermore, there was a tendency in the intervention group towards a shorter duration of nCPAP. Too little or viscose aspirate in 23% of the cases was a limitation of the method. Conclusion: Using LBC test as indicator of lung maturity and early surfactant therapy in very preterm newborns, it is possible to reduce the need for oxygen supplementation.

Generalised myasthenia gravis is a chronic, unpredictable, and debilitating autoimmune disease. New treatments for this disease are needed because conventional therapies have limitations, such as side-effects (eg, increased infection risk) or inadequate control of symptoms. Rozanolixizumab is a neonatal Fc receptor blocker that might provide a novel therapeutic option for myasthenia gravis. We aimed to assess the safety and efficacy of rozanolixizumab for generalised myasthenia gravis. MycarinG is a randomised, double-blind, placebo-controlled, adaptive phase 3 study done at 81 outpatient centres and hospitals in Asia, Europe, and North America. We enrolled patients (aged ≥18 years) with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) autoantibody-positive generalised myasthenia gravis (Myasthenia Gravis Foundation of America class II–IVa), a Myasthenia Gravis Activities of Daily Living (MG-ADL) score of at least 3 (non-ocular symptoms), and a quantitative myasthenia gravis score of at least 11. Patients were randomly assigned (1:1:1) to receive subcutaneous infusions once a week for 6 weeks of either rozanolixizumab 7 mg/kg, rozanolixizumab 10 mg/kg, or placebo. Randomisation was stratified by AChR and MuSK autoantibody status. Investigators, patients, and people assessing outcomes were masked to random assignments. The primary efficacy endpoint was change from baseline to day 43 in MG-ADL score, assessed in the intention-to-treat population. Treatment-emergent adverse events (TEAEs) were assessed in all randomly assigned patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT03971422) and EudraCT (2019-000968-18); an open-label extension study has been completed (NCT04124965; EudraCT 2019-000969-21) and another is underway (NCT04650854; EudraCT 2020-003230-20). Between June 3, 2019, and June 30, 2021, 300 patients were assessed for eligibility, of whom 200 were enrolled. 66 (33%) were randomly assigned to rozanolixizumab 7 mg/kg, 67 (34%) to rozanolixizumab 10 mg/kg, and 67 (34%) to placebo. Reductions in MG-ADL score from baseline to day 43 were greater in the rozanolixizumab 7 mg/kg group (least-squares mean change –3·37 [SE 0·49]) and in the rozanolixizumab 10 mg/kg group (–3·40 [0·49]) than with placebo (–0·78 [0·49]; for 7 mg/kg, least-squares mean difference −2·59 [95% CI −4·09 to −1·25], p<0·0001; for 10 mg/kg, −2·62 [−3·99 to −1·16], p<0·0001). TEAEs were experienced by 52 (81%) of 64 patients treated with rozanolixizumab 7 mg/kg, 57 (83%) of 69 treated with rozanolixizumab 10 mg/kg, and 45 (67%) of 67 treated with placebo. The most frequent TEAEs were headache (29 [45%] patients in the rozanolixizumab 7 mg/kg group, 26 [38%] in the rozanolixizumab 10 mg/kg group, and 13 [19%] in the placebo group), diarrhoea (16 [25%], 11 [16%], and nine [13%]), and pyrexia (eight [13%], 14 [20%], and one [1%]). Five (8%) patients in the rozanolixizumab 7 mg/kg group, seven (10%) in the rozanolixizumab 10 mg/kg group, and six (9%) in the placebo group had a serious TEAE. No deaths occurred. Rozanolixizumab showed clinically meaningful improvements in patient-reported and investigator-assessed outcomes in patients with generalised myasthenia gravis, for both 7 mg/kg and 10 mg/kg doses. Both doses were generally well tolerated. These findings support the mechanism of action of neonatal Fc receptor inhibition in generalised myasthenia gravis. Rozanolixizumab represents a potential additional treatment option for patients with generalised myasthenia gravis. UCB Pharma.