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- Cochius-den Otter, S, et al.
(författare)
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The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia
- 2019
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 9:11, s. e032122-
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Tidskriftsartikel (refereegranskat)abstract
- Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on ‘trial and error’. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking.Methods and analysisIn an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018–2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours; followed by continuous infusion of 1.6 mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) <0.05 is considered significant in all analyses.Ethics and disseminationEthics approval has been granted by the ethics committee in Rotterdam (MEC-2017-324) and the central Committee on Research Involving Human Subjects (NL60229.078.17) in the Netherlands. The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. Parental informed consent will be obtained.Trial registration numberNTR6982; Pre-results.
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- Allaire, C., et al.
(författare)
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Beam test measurements of Low Gain Avalanche Detector single pads and arrays for the ATLAS High Granularity Timing Detector
- 2018
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Ingår i: Journal of Instrumentation. - : Institute of Physics (IOP). - 1748-0221. ; 13
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Tidskriftsartikel (refereegranskat)abstract
- For the high luminosity upgrade of the LHC at CERN, ATLAS is considering the addition of a High Granularity Timing Detector (HGTD) in front of the end cap and forward calorimeters at vertical bar z vertical bar = 3:5 m and covering the region 2:4 < vertical bar eta vertical bar < 4 to help reducing the effect of pile-up. The chosen sensors are arrays of 50 mu m thin Low Gain Avalanche Detectors (LGAD). This paper presents results on single LGAD sensors with a surface area of 1.3 x 1.3 mm(2) and arrays with 2 x 2 pads with a surface area of 2 x 2 mm(2) or 3 x 3 mm(2) each and different implant doses of the p(+) multiplication layer. They are obtained from data collected during a beam test campaign in autumn 2016 with a pion beam of 120 GeV energy at the CERN SPS. In addition to several quantities measured inclusively for each pad, the gain, efficiency and time resolution have been estimated as a function of the position of the incident particle inside the pad by using a beam telescope with a position resolution of few mu m. Different methods to measure the time resolution are compared, yielding consistent results. The sensors with a surface area of 1.3 x 1.3 mm(2) have a time resolution of about 40 ps for a gain of 20 and of about 27 ps for a gain of 50 and fulfil the HGTD requirements. Larger sensors have, as expected, a degraded time resolution. All sensors show very good efficiency and time resolution uniformity.
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