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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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| 2. |
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| 3. |
- Knaapen, M, et al.
(författare)
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Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey
- 2019
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 9:5, s. e028861-
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Tidskriftsartikel (refereegranskat)abstract
- Appendicitis is a global disease affecting roughly 1 in every 12 people in the world, with the highest incidence between ages 10 and 19 years. To date, a wide variety of health outcomes have been reported in randomised controlled trials and meta-analyses evaluating treatments for appendicitis. This is especially the case in studies comparing non-operative treatment with operative treatment. A set of standard outcomes, to be reported in all future trials, is needed to allow for adequate comparison and interpretation of clinical trial results and to make data pooling possible. This protocol describes the development of such a global core outcome set (COS) to allow unified reporting of treatment interventions in children with acute uncomplicated appendicitis.Methods and analysisWe use current international standard methodology for the development and reporting of this COS. Its development consists of three phases: (1) an update of the most recent systematic review on outcomes reported in uncomplicated paediatric appendicitis research to identify additional outcomes, (2) a three-step global Delphi study to identify a set of core outcomes for which there is consensus between parents and (paediatric) surgeons and (3) an expert meeting to finalise the COS and its definitions. Children and young people will be involved through their parents during phase 2 and will be engaged directly using a customised face-to-face approach.Ethics and disseminationThe medical research ethics committee of the Academic Medical Center Amsterdam has approved the study. Each participating country/research group will ascertain ethics board approval. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at (international) conferences.Trial registration numberCOMET registration: 1119
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| 5. |
- Kalman, Björn, 1961-, et al.
(författare)
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Estimation of durability of new surface courses using accelerated load test and expert's opinions
- 2022
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Ingår i: Proceedings of the 11th International Conference on the Bearing Capacity of Roads, Railways and Airfields. - London : CRC Press. - 9781003222910 ; , s. 502-510
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Konferensbidrag (refereegranskat)abstract
- There is an increasing interest among road authorities in studying sustain ability assessment of road infrastructure. The durability of the surface course is a critical factor in these calculations and must be carefully considered in the analysis. New types of asphalt mixes with the potential to improve the results in the sustainability assessment have no proven track record and are thus more likely not to be used until solid perform ance data is available. To bridge the gap and diminish the uncertainty about the durability of Green asphalt mixes for surface courses, a combination of laboratory tests and tests in a circular road simulator were performed. Eight mixes were tested in total, four stone mastic asphalt mixes and four porous asphalt mixes. Each group contained a reference mix with well-established performance. The mixes were characterized with dynamic IDT, com plex shear modulus and water sensitivity using MiST (moisture induced stress test). Part of the loose mixes was oven aged at 85 °C simulate long term ageing. Plates of aged and virgin mixes were then tested in a circular road simulator in a program set up to check their sensitivity towards rutting, raveling, freeze-thaw cycles, polishing and fatigue. A combination of expert’s opinion from academia and national road administrations together with the data from the tests were used to estimate the performance of the new Green mixes.
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