Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis:a multicentre, randomised controlled trial (NeoPIns)
| العنوان: | Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis:a multicentre, randomised controlled trial (NeoPIns) |
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| المؤلفون: | B Manai, M Stocker, Fam van den Dungen, Mathias Nelle, Matteo Fontana, Faba Schuerman, L de Ligt, M Visnovska, S Alliston, SD Sie, Mark Alan Fontana, Angelique Hoffman-Haringsma, S Hill, MM van Weissenbruch, René F. Kornelisse, Albertine E Donker, D Glauser, Wendy van Herk, R Kornelisse, N Lanz, Laura H van der Meer-Kappelle, Groot A van Rossum, Sintha D. Sie, R Moonen, S Dutta, EG Visser, M Strik, W van Herk, Rob Moonen, LJ Schlapbach, Salhab el Helou, Urs Zimmerman, Martin Stocker, A Donker, M Batstra, Jantien W Wieringa, Luregn J. Schlapbach, Peter Andriessen, GJ van der Geijn, Wim C. J. Hop, J van der Velden, AC de Mol, U Zimmerman, LH van der Meer-Kappelle, A van Rossum, David Pogorzelski, Sten P. Willemsen, S Siiskonen, Jan Janota, A Haringsma, Ipe Gondriet, Juliette van Gijsel, S el Helou, Y.B. de Rijke, S Willemsen, Sourabh Dutta, Esther de Vries, S Hoekstein, E.G.E. de Vries, Mac Broeren, M Hofhuis, Amerik C. de Mol, J van Gijsel, Eline G. Visser, J Bolt-Wieringa, V Grey, Frank A B A Schuerman, K Hauff, Maren Tomaske, Marc-André Roy, S Donker, A Bakry, Madan Roy, HK van den Tooren-de, S Kittanakom, J Janota, Daniel Stok, J Asch van Wijk, K Kalaniti, M Tomaske, Annemarie M. C. van Rossum, Rita K van den Tooren-de Groot |
| المساهمون: | Pediatrics, Public Health, Obstetrics & Gynecology, Pediatric surgery, ACS - Diabetes & metabolism, Amsterdam Reproduction & Development (AR&D), Amsterdam Gastroenterology Endocrinology Metabolism |
| المصدر: | Stocker, M, van Herk, W, el Helou, S, Dutta, S, Fontana, M S, Schuerman, F A B A, van den Tooren-de Groot, R K, Wieringa, J W, Janota, J, van der Meer-Kappelle, L H, Moonen, R, Sie, S D, de Vries, E, Donker, A E, Zimmerman, U, Schlapbach, L J, de Mol, A C, Hoffman-Haringsma, A, Roy, M, Tomaske, M, Kornelisse, R F, van Gijsel, J, Visser, E G, Willemsen, S P, van Rossum, A M C & NeoPInS Study Group 2017, ' Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis : a multicentre, randomised controlled trial (NeoPIns) ', The Lancet, vol. 390, no. 10097, pp. 871-881 . https://doi.org/10.1016/S0140-6736(17)31444-7 Lancet (UK), 390(10097), 871-881. Elsevier Ltd. The Lancet, 390(10097), 871-881. Elsevier Limited |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Calcitonin, Male, Pediatrics, medicine.medical_specialty, Internationality, Time Factors, medicine.drug_class, Antibiotics, Decision Making, Gestational Age, Procalcitonin, Infant, Newborn, Diseases, law.invention, Sepsis, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030225 pediatrics, Antibiotic therapy, medicine, Humans, 030212 general & internal medicine, Intention-to-treat analysis, business.industry, Infant, Newborn, Gestational age, Infant, General Medicine, medicine.disease, Anti-Bacterial Agents, Early Diagnosis, Treatment Outcome, Female, Parental consent, Drug Monitoring, business, Biomarkers |
| الوصف: | Background Up to 7% of term and late-preterm neonates in high-income countries receive antibiotics during the first 3 days of life because of suspected early-onset sepsis. The prevalence of culture-proven early-onset sepsis is 0·1% or less in high-income countries, suggesting substantial overtreatment. We assess whether procalcitonin-guided decision making for suspected early-onset sepsis can safely reduce the duration of antibiotic treatment. Methods We did this randomised controlled intervention trial in Dutch (n=11), Swiss (n=4), Canadian (n=2), and Czech (n=1) hospitals. Neonates of gestational age 34 weeks or older, with suspected early-onset sepsis requiring antibiotic treatment were stratified into four risk categories by their treating physicians and randomly assigned [1:1] using a computer-generated list stratified per centre to procalcitonin-guided decision making or standard care-based antibiotic treatment. Neonates who underwent surgery within the first week of life or had major congenital malformations that would have required hospital admission were excluded. Only principal investigators were masked for group assignment. Co-primary outcomes were non-inferiority for re-infection or death in the first month of life (margin 2·0%) and superiority for duration of antibiotic therapy. Intention-to-treat and per-protocol analyses were done. This trial was registered with ClinicalTrials.gov, number NCT00854932. Findings Between May 21, 2009, and Feb 14, 2015, we screened 2440 neonates with suspected early-onset sepsis. 622 infants were excluded due to lack of parental consent, 93 were ineligible for reasons unknown (68), congenital malformation (22), or surgery in the first week of life (3). 14 neonates were excluded as 100% data monitoring or retrieval was not feasible, and one neonate was excluded because their procalcitonin measurements could not be taken. 1710 neonates were enrolled and randomly assigned to either procalcitonin-guided therapy (n=866) or standard therapy (n=844). 1408 neonates underwent per-protocol analysis (745 in the procalcitonin group and 663 standard group). For the procalcitonin group, the duration of antibiotic therapy was reduced (intention to treat: 55·1 vs 65·0 h, p |
| اللغة: | English |
| تدمد: | 0140-6736 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a2fcd49b436336d996370910b9ffacc0 https://research.vumc.nl/en/publications/c69a05d1-c20f-4c78-ae0e-2da2022b86ae |
| حقوق: | RESTRICTED |
| رقم الأكسشن: | edsair.doi.dedup.....a2fcd49b436336d996370910b9ffacc0 |
| قاعدة البيانات: | OpenAIRE |
Full Text via ClinicalKey | تدمد: | 01406736 |
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