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  • 1
    Online Resource
    Online Resource
    Treatment of Infants and Children With SARS-CoV-2 Monoclonal Antibodies: A European Case Series
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Pediatric Infectious Disease Journal Vol. 42, No. 2 ( 2023-02), p. 125-129
    Details
    In: Pediatric Infectious Disease Journal, Ovid Technologies (Wolters Kluwer Health), Vol. 42, No. 2 ( 2023-02), p. 125-129
    Abstract: Although severe COVID-19 in children is rare, those with certain pre-existing health conditions are more prone to severe disease. Monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are potent antiviral agents that reduce adverse clinical outcomes in adults, but are commonly not approved for use in pediatric patients. Methods: We retrospectively evaluated mAb treatment in children 〈 12 years of age or 〈 40kg with SARS-CoV-2 infection between January 1, 2021, and March 7, 2022, in 12 tertiary care centers in 3 European countries. Results: We received data from 53 patients from Austria, Denmark and Germany. Median age was 5.4 years [0–13.8, interquartile range (IQR) = 6.2], and median body weight was 20 kg (3–50.1, IQR = 13). The most frequent SARS-CoV-2 variant in this study, if known, was Omicron, followed by Delta and Alpha. Pre-existing conditions included immunodeficiency, malignancy, hematologic disease, cardiac disease, chronic lung disease, chronic liver disease, kidney disease and diabetes. Forty-two patients received sotrovimab (79%), 9 casirivimab/imdevimab (17%) and 2 bamlanivimab (4%). All but 1 patient survived. Median duration of hospital stay was 3 days (0–56, IQR = 6). Seven patients required treatment in an intensive care unit, and 5 required high-flow nasal cannula treatment. Potential side effects included neutropenia (6/53, 11%), lymphopenia (3/53, 6%), nausea or vomiting (2/53, 4%), rise of alanine transaminase (1/53, 2%) and hypotonia (1/53, 2%). Conclusions: MAb treatment was well tolerated by children in this cohort.
    Type of Medium: Online Resource
    ISSN: 0891-3668
    URL: Article
    DOI: 10.1097/INF.0000000000003773
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2020216-7
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  • 2
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    Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial
    Springer Science and Business Media LLC ; 2021
    In:  Trials Vol. 22, No. 1 ( 2021-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: Preterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust association between prematurity and increased cardiovascular risk factors and cardiovascular mortality. While the innate adverse effects of prematurity on these outcomes have been demonstrated, therapeutic strategies on the mitigation of these concerning developments are lacking. The primary objective of the NEOVASC clinical trial is therefore to investigate whether the administration of a prolonged exclusive human-milk diet in preterm infants is capable of alleviating the harmful effects of preterm birth on the early development of cardiovascular risk factors. Methods The NEOVASC study is a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial conducted in four Austrian tertiary neonatal care facilities. The purpose of the present trial is to investigate the effects of a prolonged exclusive human-milk-diet devoid of bovine-milk-based food components on cardiovascular and metabolic risk factors at 1, 2, and 5 years of corrected age. Primary outcomes include assessments of fasting blood glucose levels, blood pressure levels, and the distensibility of the descending aorta using validated echocardiographic protocols at 5 years of corrected age. The test group, which consists of 200 preterm infants, will therefore be compared to a control group of 100 term-born infants and a historical control group recruited previously. Discussion Given the emerging implications of an increased cardiovascular risk profile in the potentially growing population of preterm infants, further research on the mitigation of long-term morbidities in formerly preterm infants is urgently warranted. Further optimizing preterm infants’ nutrition by removing bovine-milk-based food components may therefore be an interesting approach worth pursuing. Trial registration ClinicalTrials.gov NCT04413994. Registered on 4 June 2020.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-021-05445-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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  • 3
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    Breath‐dependent pressure fluctuations in various constant‐ and variable‐flow neonatal CPAP devices
    Wiley ; 2022
    In:  Pediatric Pulmonology Vol. 57, No. 10 ( 2022-10), p. 2411-2419
    Details
    In: Pediatric Pulmonology, Wiley, Vol. 57, No. 10 ( 2022-10), p. 2411-2419
    Abstract: In continuous positive airway pressure (CPAP) devices, pressure can be generated by two different mechanisms: either via an expiratory valve or by one or more jets. Valved CPAP devices are referred to as constant‐flow devices, and jet devices are called variable‐flow devices. Constant‐flow CPAP devices are said to reduce the imposed work of breathing due to lower breath‐dependent pressure fluctuations. The present study investigates the performance of various constant‐ and variable‐flow CPAP devices in relation to breath‐dependent pressure fluctuations. Design Experimental study comparing the pressure fluctuations incurred by seven neonatal CPAP devices attached to an active neonatal lung model. Methodology Spontaneous breathing was simulated using a tidal volume of 6 ml at pressure levels of 5, 7, and 9 mbar. The main outcomes were respiratory pressure fluctuations, tidal volume, and end‐expiratory pressure. Results All CPAP devices tested showed respiratory pressure fluctuations, varying from 0.631 to 3.466 mbar. The generated tidal volume correlated significantly with the pressure fluctuations ( r  = −0.947; p  = 0.001) and varied between 5.550 and 6.316 ml. CPAP devices with jets showed no advantage over CPAP devices with expiratory valves. End‐expiratory pressure in the nose deviated from the set pressure between −1.305 and 0.644 mbar and varied depending on whether the pressure was measured in the device or in the tube extending to the nose. Conclusion During standard spontaneous breathing, breath‐dependent pressure fluctuations in constant‐ and variable‐flow devices are comparable. Pressure measurements taken in the tubing system can lead to a considerable deviation of the applied pressure.
    Type of Medium: Online Resource
    ISSN: 8755-6863 , 1099-0496
    URL: Issue
    URL: Article
    DOI: 10.1002/ppul.v57.10
    DOI: 10.1002/ppul.26050
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 1491904-7
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  • 4
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    Online Resource
    Introduction and feeding practices of solid food in preterm infants born in Salzburg!
    Springer Science and Business Media LLC ; 2021
    In:  BMC Pediatrics Vol. 21, No. 1 ( 2021-12)
    Details
    In: BMC Pediatrics, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2021-12)
    Abstract: It is shown that meeting the increased nutritional demand of preterm infants from birth is not only important for survival but essentially contributes to the infants` overall development and long-term health. While there are established guidelines for weaning term infants, evidence regarding preterm infants is scarce and less precise. The aim of this study was to identify the current practices on introducing solids to preterm infants amongst caregivers in Salzburg and determine potential reasons for early weaning. Methods Altogether 68 infants born between 24 0/7 and 36 6/7 weeks were recruited and detailed structured interviews with the caregivers were conducted at 17 weeks corrected age. Weight, height and head circumference were collected. Results 52% of the study group received solids before the recommended 17 weeks corrected age. For this group the mean age being 13.77 ± 1.11 weeks corrected age. Premature introduction of solids significantly correlates with exclusively and early formula-feeding. 34% were weaned due to recommendation by their paediatrician. 23% of the preterm infants even received solids before 12 weeks corrected age, putting them at risks for developing obesity, celiac disease and diabetes. Conclusions This study shows the necessity for clear guidelines regarding the introduction of complementary feeding in preterm infants as well as the importance of their implementation. Caregivers should receive information on this topic early enough and they should fully understand the difference between chronological and corrected age.
    Type of Medium: Online Resource
    ISSN: 1471-2431
    URL: Article
    DOI: 10.1186/s12887-021-02505-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2041342-7
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  • 5
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    Online Resource
    A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome—a randomized controlled trial
    Springer Science and Business Media LLC ; 2022
    In:  BMC Pediatrics Vol. 22, No. 1 ( 2022-11-04)
    Details
    In: BMC Pediatrics, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2022-11-04)
    Abstract: In respiratory distress syndrome, many neonatology centers worldwide perform minimal invasive surfactant application in premature infants, using small-diameter catheters for endotracheal intubation and surfactant administration. Methods In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomized to two different modes of endotracheal catheterization: Flexible charrière-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate (intraventricular hemorrhage, soft-tissue damage in first week of life) and vital parameters during laryngoscopy. Between 2019 and 2020, 31 infants were included in the study. Prior to in-vivo testing, laryngoscopy durations were studied on a neonatal airway mannequin in students, nurses and doctors. Results Mean gestational age and birth weight were 27 + 6/7 weeks and 1009 g; and 28 + 0/7 weeks and 1127 g for group 1 and 2, respectively. Length of laryngoscopy was similar in both groups (61.1 s and 64.9 s) overall (p.77) and adjusted for weight (p.70) or gestational age (p.95). Laryngoscopy failed seven times in group 1 (43.8%) and four times (26.7%) in group 2 (p.46). Longer laryngoscopy was associated with lower oxygen saturation with lowest levels occurring after failed laryngoscopy attempts. Secondary outcomes were similar in both groups. In vitro data on 40 students, 40 nurses and 12 neonatologists showed significant faster laryngoscopy in students and nurses group 2 ( p   〈  .0001) unlike in neonatologists (p.13). Conclusion This study showed no difference in laryngoscopy duration in endotracheal catheterization when comparing semi-rigid and flexible catheters for minimal invasive surfactant application in preterm infants. In accordance with preliminary data and in contrast to published in-vitro trials, experienced neonatologists were able to perform endotracheal catheterization using both semi-rigid and flexible catheters at similar rates and ease, in vitro and in vivo. Trial registration ClinicalTrials.gov. NCT05024435 Registered 27 August 2021—Retrospectively registered.
    Type of Medium: Online Resource
    ISSN: 1471-2431
    URL: Article
    DOI: 10.1186/s12887-022-03714-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2041342-7
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  • 6
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    Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial
    The Endocrine Society ; 2020
    In:  The Journal of Clinical Endocrinology & Metabolism Vol. 105, No. 4 ( 2020-04-01), p. e1847-e1861
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 105, No. 4 ( 2020-04-01), p. e1847-e1861
    Abstract: Daily growth hormone (GH) injections can be burdensome for patients and carers. Somapacitan is a long-acting, reversible albumin-binding GH derivative in development for once-weekly administration in patients with growth hormone deficiency (GHD). Objective The objective of this study is to evaluate the efficacy, safety, and tolerability of once-weekly somapacitan vs once-daily GH. Design REAL 3 is a multicenter, randomized, controlled, double-blind (somapacitan doses), phase 2 study with a 26-week main and 26-week extension phase (NCT02616562). Setting This study took place at 29 sites in 11 countries. Patients Fifty-nine GH treatment-naive prepubertal children with GHD were randomly assigned; 58 completed the trial. Interventions Interventions comprised 3 somapacitan doses (0.04 [n = 16], 0.08 [n = 15] , or 0.16 mg/kg/wk [n = 14]) and daily GH (0.034 mg/kg/d [n = 14] ), administered subcutaneously. Main Outcome Measures The primary end point was height velocity (HV) at week 26. Secondary efficacy end points included HV SD score (SDS) and insulin-like growth factor-I (IGF-I) SDS. Results At week 26, mean (SD) annualized HV for the somapacitan groups was 8.0 (2.0), 10.9 (1.9), and 12.9 (3.5) cm/year, respectively, vs 11.4 (3.3) cm/year for daily GH; estimated treatment difference (somapacitan 0.16 mg/kg/week—daily GH): 1.7 [95% CI –0.2 to 3.6] cm/year. HV was sustained at week 52, and significantl y greater with somapacitan 0.16 mg/kg/week vs daily GH. Mean (SD) change from baseline in HV SDS at week 52 was 4.72 (2.79), 6.14 (3.36), and 8.60 (3.15) for the somapacitan groups, respectively, vs 7.41 (4.08) for daily GH. Model-derived mean (SD) IGF-I SDS for the somapacitan groups was −1.62 (0.86), −1.09 (0.78), and 0.31 (1.06), respectively, vs −0.40 (1.50) observed for daily GH. Safety and tolerability were consistent with the profile of daily GH. Conclusions In children with GHD, once-weekly somapacitan 0.16 mg/kg/week provided the closest efficacy match with similar safety and tolerability to daily GH after 26 and 52 weeks of treatment. A short visual summary of our work is available (1).
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/clinem/dgz310
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2020
    detail.hit.zdb_id: 2026217-6
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  • 7
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    Normal fetal lung development in a singleton child with bilateral renal agenesis—a paradox?
    Springer Science and Business Media LLC ; 2020
    In:  Der Gynäkologe Vol. 53, No. 11 ( 2020-11), p. 784-788
    Details
    In: Der Gynäkologe, Springer Science and Business Media LLC, Vol. 53, No. 11 ( 2020-11), p. 784-788
    Type of Medium: Online Resource
    ISSN: 0017-5994 , 1433-0393
    URL: Article
    DOI: 10.1007/s00129-020-04685-1
    RVK:
    XA 45550
    Language: German
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 1459161-3
    detail.hit.zdb_id: 3122868-9
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  • 8
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    When synchronized isn't synchronous- an experimental benchmarking study on the efficiency of SIMV in very-low-birth weight premature infants
    Edizioni Minerva Medica ; 2021
    In:  Minerva Pediatrics ( 2021-11)
    Details
    In: Minerva Pediatrics, Edizioni Minerva Medica, ( 2021-11)
    Type of Medium: Online Resource
    ISSN: 2724-5780
    URL: Article
    DOI: 10.23736/S2724-5276.21.06538-1
    Language: English
    Publisher: Edizioni Minerva Medica
    Publication Date: 2021
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