15 results on '"Iveli, Pablo"'
Search Results
2. Hepatotoxicidad en el lactante sano expuesto a nevirapina durante el embarazo
- Author
-
Iveli, Pablo, Noguera-Julian, Antoni, Soler-Palacín, Pere, Martín-Nalda, Andrea, Rovira-Girabal, Núria, Fortuny-Guasch, Clàudia, and Figueras-Nadal, Concepció
- Published
- 2016
- Full Text
- View/download PDF
3. Prescripciones off-label en psiquiatría infanto-juvenil. ¿Por qué, cuándo y cómo?
- Author
-
Iveli, María Florencia, primary, Monti, Mariano, additional, Benito, María Eugenia, additional, and Iveli, Pablo, additional
- Published
- 2022
- Full Text
- View/download PDF
4. recommendations by the Conect4Children expert advice group
- Author
-
Ramanan, Athimalaipet V., Modi, Neena, de Wildt, Saskia N., Aurich, Beate, Bakhtadze, Sophia, Sirvent, Francisco J.Bautista, Cabañas, Fernando, Campbell, Lisa, Casanova, Michaela, Charlton, Philippa, Crandall, Wallace, Eichler, Irmgard, Fregonese, Laura, Hawcutt, Daniel B., Iveli, Pablo, Jaki, Thomas, Jocic-Jakubi, Bosanka, Johnson, Mats, Kaguelidou, Florentina, Karadag, Bülent, Kelly, Lauren E., Lim, Ming, Moreno, Carmen, Neumann, Eva, Ollivier, Cécile, Oualha, Mehdi, Raffaeli, Genny, Ribeiro, Maria A., Roilides, Emmanuel, de Rojas, Teresa, Simón, Alba Rubio San, Ruperto, Nicolino, Scarpa, Maurizio, Schwab, Matthias, Siapkara, Angeliki, Singh, Yogen, Smits, Anne, Striano, Pasquale, Urru, Silvana A.M., Vivarelli, Marina, de Wildt, Saskia, Zivkoviz, Zorica, and NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
- Subjects
Pediatrics, Perinatology, and Child Health - Abstract
Funding Information: Competing interests: A.V.R. has received Speaker fees/Consultant for Abbvie, Novartis, UCB, SOBI, Eli Lilly and Roche. N.M. reports grants outside the submitted work in the last five years from the Medical Research Council, National Institute of Health Research, March of Dimes, British Heart Foundation, HCA international, Health Data Research UK, Shire Pharmaceuticals, Chiesi Pharmaceuticals, Prolacta Life Sciences, and Westminster Children’s Research Fund; N.M. is a member of the Nestle Scientific Advisory Board and accepts no personal remuneration for this role. N.M. reports travel and accommodation reimbursements from Chiesi, Nestle and Shire. N.M. is a member of C4C, International Neonatal Collaboration (INC), UK National Research Ethics Advisory Service and MHRA advisory groups and/or working parties. S.W. has received compensation as a member of the scientific advisory board of AM Pharma, Novartis and Khondrion and receives research funding from IMI2 for the Conect4children project. B.A. has worked for GlaxoSmithKline between October 2006 and September 2009 and holds company shares. Between October 2009 and May 2015, she has worked for Novartis. M.S. has recieved research grant and honoraria for meetings and Advisory Boards from Alexion, Sanofi/Genzyme, Takeda, CHIESI, Ultragenix, Orchard, Orphazyme. P.I. is a permanent employee of Bayer AG, Germany. M.V. has received compensation for Advisory boards or Steering committes from Roche, Novartis, Achillion, Apellis, Retrophin/Travere, Alexion pharmaceuticals. C.M. has been a consultant to or has received honoraria from Janssen, Angelini, Servier, Nuvelution, Otsuka, Lundbeck, Pfizer, Neuraxpharm and Esteve outside the submitted work. She declares conflicts of interest unrelated to the present work. M.C. had advisory roles for AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Lilly, and Roche in the last 2 years (outside the topic of the submitted work, for oncology drugs). M.J. has received research grants from Shire and has been engaged as a speaker or consultant by Shire, Ginsana, PCM Scientific Evolan, and New Nordic, all unrelated to the present work. P.S. has received speaker fees and participated at advisory boards for Biomarin, Zogenyx, GW Pharmaceuticals, and has received research funding by ENECTA BV, GW Pharmaceuticals, Kolfarma srl., Eisai. E.R. has received speaker fees and participated at advisory boards for Eisai and has received research funding by GW Pharmaceuticals, Pfizer, Italian Ministry of Health (MoH) and the Italian Medicine Agency (AIFA). This work was developed within the framework of the DINOGMI Department of Excellence of MIUR 2018-2022 (legge 232 del 2016). M.A.R. is a member of the c4c Ethics Expert Group and received compensation for ethical consulting activities from Bayer AG Wallace Crandall is employee of Eli Lilly and Co. P.C. is an employee of UCB, and owns stock in the company. She was previously an employee of GSK and owns stock in the company. N.R. has received honoraria for consultancies or speaker bureaus from the following pharmaceutical companies in the past 3 years: Ablynx, Amgen, Astrazeneca-Medimmune, Aurinia, Bayer, Bristol Myers and Squibb, Cambridge Healthcare Research (CHR), Celgene, Domain therapeutic, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Idorsia, Janssen, Novartis, Pfizer, Sobi, UCB. The IRCCS Istituto Giannina Gaslini (IGG), where NR works as full-time public employee has received contributions from the following industries in the last 3 years: Bristol Myers and Squibb, Eli-Lilly, F Hoffmann-La Roche, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties. M.L. receives/has received consultation fees from CSL Behring, Novartis, Roche and Octopharma, travel grants from Merck Serono, and been awarded educational grants to organise meetings by Novartis, Biogen Idec, Merck Serono and Bayer. All other authors have no disclosures. Funding Information: Conect4children has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The views expressed in this article are the personal views of the author(s) and should not be interpreted as made on behalf of, or reflecting the position of, the regulatory agency/agencies or organisations with which the author(s) is/are employed/affiliated . Publisher Copyright: © 2021, The Author(s). Background: The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. Methods: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. Findings: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area. publishersversion epub_ahead_of_print
- Published
- 2022
5. Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group
- Author
-
Ramanan, Athimalaipet V., Modi, Neena, de Wildt, Saskia N., Aurich, Beate, Bakhtadze, Sophia, Sirvent, Francisco J. Bautista, Cabañas, Fernando, Campbell, Lisa, Casanova, Michaela, Charlton, Philippa, Crandall, Wallace, Eichler, Irmgard, Fregonese, Laura, Hawcutt, Daniel B., Iveli, Pablo, Jaki, Thomas, Jocic-Jakubi, Bosanka, Johnson, Mats, Kaguelidou, Florentina, Karadag, Bülent, Kelly, Lauren E., Lim, Ming, Moreno, Carmen, Neumann, Eva, Ollivier, Cécile, Oualha, Mehdi, Raffaeli, Genny, Ribeiro, Maria A., Roilides, Emmanuel, de Rojas, Teresa, Simón, Alba Rubio San, Ruperto, Nicolino, Scarpa, Maurizio, Schwab, Matthias, Siapkara, Angeliki, Singh, Yogen, Smits, Anne, Striano, Pasquale, Urru, Silvana A. M., Vivarelli, Marina, de Wildt, Saskia, Zivkoviz, Zorica, Pediatric Surgery, and Ramanan A. V. , Modi N., de Wildt S. N. , Aurich B., Bakhtadze S., Sirvent F. J. B. , Cabañas F., Campbell L., Casanova M., Charlton P., et al.
- Subjects
2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Expert advice ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,MEDLINE ,Sağlık Bilimleri ,Pediatrics ,Clinical Medicine (MED) ,Çocuk Sağlığı ve Hastalıkları ,Child Health and Diseases ,Special Article ,03 medical and health sciences ,0302 clinical medicine ,Health Sciences ,Health care ,Humans ,Klinik Tıp (MED) ,030212 general & internal medicine ,Pediatrics, Perinatology, and Child Health ,Pediatri, Perinatoloji ve Çocuk Sağlığı ,Child ,Pandemics ,Internal Medicine Sciences ,Klinik Tıp ,business.industry ,Research ,COVID-19 ,Dahili Tıp Bilimleri ,CLINICAL MEDICINE ,Public relations ,Tıp ,3. Good health ,Europe ,Clinical research ,030220 oncology & carcinogenesis ,Pediatrics, Perinatology and Child Health ,Medicine ,PEDİATRİ ,Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] ,business - Abstract
Background The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. Methods We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. Findings We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.
- Published
- 2021
- Full Text
- View/download PDF
6. Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience
- Author
-
Duarte-Salles, Talita, primary, Vizcaya, David, additional, Pistillo, Andrea, additional, Casajust, Paula, additional, Sena, Anthony G., additional, Lai, Lana Yin Hui, additional, Prats-Uribe, Albert, additional, Ahmed, Waheed-Ul-Rahman, additional, Alshammari, Thamir M., additional, Alghoul, Heba, additional, Alser, Osaid, additional, Burn, Edward, additional, You, Seng Chan, additional, Areia, Carlos, additional, Blacketer, Clair, additional, DuVall, Scott, additional, Falconer, Thomas, additional, Fernandez-Bertolin, Sergio, additional, Fortin, Stephen, additional, Golozar, Asieh, additional, Gong, Mengchun, additional, Tan, Eng Hooi, additional, Huser, Vojtech, additional, Iveli, Pablo, additional, Morales, Daniel R., additional, Nyberg, Fredrik, additional, Posada, Jose D., additional, Recalde, Martina, additional, Roel, Elena, additional, Schilling, Lisa M., additional, Shah, Nigam H., additional, Shah, Karishma, additional, Suchard, Marc A., additional, Zhang, Lin, additional, Zhang, Ying, additional, Williams, Andrew E., additional, Reich, Christian G., additional, Hripcsak, George, additional, Rijnbeek, Peter, additional, Ryan, Patrick, additional, Kostka, Kristin, additional, and Prieto-Alhambra, Daniel, additional
- Published
- 2021
- Full Text
- View/download PDF
7. Thirty-day outcomes of children and adolescents with COVID-19:An international experience
- Author
-
Duarte-Salles, Talita, Vizcaya, David, Pistillo, Andrea, Casajust, Paula, Sena, Anthony G., Hui Lai, Lana Yin, Prats-Uribe, Albert, Ahmed, Waheed Ul Rahman, Alshammari, Thamir M., Alghoul, Heba, Alser, Osaid, Burn, Edward, You, Seng Chan, Areia, Carlos, Blacketer, Clair, DuVall, Scott, Falconer, Thomas, Fernandez-Bertolin, Sergio, Fortin, Stephen, Golozar, Asieh, Gong, Mengchun, Tan, Eng Hooi, Huser, Vojtech, Iveli, Pablo, Morales, Daniel R., Nyberg, Fredrik, Posada, Jose D., Recalde, Martina, Roel, Elena, Schilling, Lisa M., Shah, Nigam H., Shah, Karishma, Suchard, Marc A., Zhang, Lin, Zhang, Ying, Williams, Andrew E., Reich, Christian G., Hripcsak, George, Rijnbeek, Peter, Ryan, Patrick, Kostka, Kristin, Prieto-Alhambra, Daniel, Duarte-Salles, Talita, Vizcaya, David, Pistillo, Andrea, Casajust, Paula, Sena, Anthony G., Hui Lai, Lana Yin, Prats-Uribe, Albert, Ahmed, Waheed Ul Rahman, Alshammari, Thamir M., Alghoul, Heba, Alser, Osaid, Burn, Edward, You, Seng Chan, Areia, Carlos, Blacketer, Clair, DuVall, Scott, Falconer, Thomas, Fernandez-Bertolin, Sergio, Fortin, Stephen, Golozar, Asieh, Gong, Mengchun, Tan, Eng Hooi, Huser, Vojtech, Iveli, Pablo, Morales, Daniel R., Nyberg, Fredrik, Posada, Jose D., Recalde, Martina, Roel, Elena, Schilling, Lisa M., Shah, Nigam H., Shah, Karishma, Suchard, Marc A., Zhang, Lin, Zhang, Ying, Williams, Andrew E., Reich, Christian G., Hripcsak, George, Rijnbeek, Peter, Ryan, Patrick, Kostka, Kristin, and Prieto-Alhambra, Daniel
- Abstract
OBJECTIVES: To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children and adolescents diagnosed or hospitalized with coronavirus disease 2019 (COVID-19) and to compare them in secondary analyses with patients diagnosed with previous seasonal influenza in 2017–2018. METHODS: International network cohort using real-world data from European primary care records (France, Germany, and Spain), South Korean claims and US claims, and hospital databases. We included children and adolescents diagnosed and/or hospitalized with COVID-19 at age <18 between January and June 2020. We described baseline demographics, comorbidities, symptoms, 30-day in-hospital treatments, and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome, multisystem inflammatory syndrome in children, and death. RESULTS: A total of 242 158 children and adolescents diagnosed and 9769 hospitalized with COVID-19 and 2 084 180 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were more common among those hospitalized with versus diagnosed with COVID-19. Dyspnea, bronchiolitis, anosmia, and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital prevalent treatments for COVID-19 included repurposed medications (<10%) and adjunctive therapies: systemic corticosteroids (6.8%–7.6%), famotidine (9.0%–28.1%), and antithrombotics such as aspirin (2.0%–21.4%), heparin (2.2%–18.1%), and enoxaparin (2.8%–14.8%). Hospitalization was observed in 0.3% to 1.3% of the cohort diagnosed with COVID-19, with undetectable (n < 5 per database) 30-day fatality. Thirty-day outcomes including pneumonia and hypoxemia were more frequent in COVID-19 than influenza. CONCLUSIONS: Despite negligible fatality, complications including hospitalization, hypoxemia, and pneumonia were more frequent in children and adolescents with COVID-19 than with inf
- Published
- 2021
8. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial.
- Author
-
Stahl, Andreas, Sukgen, Emine A., Wu, Wei-Chi, Lepore, Domenico, Nakanishi, Hidehiko, Mazela, Jan, Moshfeghi, Darius M., Vitti, Robert, Athanikar, Aditya, Chu, Karen, Iveli, Pablo, Zhao, Fei, Schmelter, Thomas, Leal, Sergio, Koefuencue, Evra, Azuma, Noriyuki, FIREFLEYE Study Group, and Köfüncü, Evra
- Abstract
Importance: Laser photocoagulation, which is the standard treatment for retinopathy of prematurity (ROP), can have adverse events. Studies of anti-vascular endothelial growth factor injections have suggested efficacy in the treatment of ROP, but few studies have directly compared them with laser treatments.Objective: To compare intravitreal aflibercept vs laser photocoagulation in infants with ROP requiring treatment.Design, Setting, and Participants: This noninferiority, phase 3, 24-week, randomized clinical trial was conducted in 27 countries (64 hospital sites) throughout Asia, Europe, and South America. Overall, 118 infants (gestational age ≤32 weeks at birth or birth weight ≤1500 g) with ROP severity (zone I stage 1+ [stage 1 plus increased disease activity], zone I stage 2+, zone I stage 3, zone I stage 3+, zone II stage 2+, or zone II stage 3+) requiring treatment or with aggressive posterior ROP in at least 1 eye were enrolled between September 25, 2019, and August 28, 2020 (the last visit occurred on February 12, 2021).Interventions: Infants were randomized 2:1 to receive a 0.4-mg dose of intravitreal aflibercept (n = 75) or laser photocoagulation (n = 43) at baseline. Additional treatment was allowed as prespecified.Main Outcomes and Measures: The primary outcome was the proportion of infants without active ROP and unfavorable structural outcomes 24 weeks after starting treatment (assessed by investigators). The requirement for rescue treatment was considered treatment failure. Intravitreal aflibercept was deemed noninferior if the lower limit of the 1-sided 95% bayesian credible interval for the treatment difference was greater than -5%.Results: Among 118 infants randomized, 113 were treated (mean gestational age, 26.3 [SD, 1.9] weeks; 53 [46.9%] were female; 16.8% had aggressive posterior ROP, 19.5% had zone I ROP, and 63.7% had zone II ROP) and 104 completed the study. Treatment (intravitreal aflibercept: n = 75; laser photocoagulation: n = 38) was mostly bilateral (92.9%), and 82.2% of eyes in the intravitreal aflibercept group received 1 injection per eye. Treatment success was 85.5% with intravitreal aflibercept vs 82.1% with laser photocoagulation (between-group difference, 3.4% [1-sided 95% credible interval, -8.0% to ∞]). Rescue treatment was required in 4.8% (95% CI, 1.9% to 9.6%) of eyes in the intravitreal aflibercept group vs 11.1% (95% CI, 4.9% to 20.7%) of eyes in the laser photocoagulation group. The serious adverse event rates were 13.3% (ocular) and 24.0% (systemic) in the intravitreal aflibercept group compared with 7.9% and 36.8%, respectively, in the laser photocoagulation group. Three deaths, which occurred 4 to 9 weeks after intravitreal aflibercept treatment, were considered unrelated to aflibercept by the investigators.Conclusions and Relevance: Among infants with ROP, intravitreal aflibercept compared with laser photocoagulation did not meet criteria for noninferiority with respect to the primary outcome of the proportion of infants achieving treatment success at week 24. Further data would be required for more definitive conclusions regarding the comparative effects of intravitreal aflibercept and laser photocoagulation in this population.Trial Registration: ClinicalTrials.gov Identifier: NCT04004208. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
9. Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group.
- Author
-
Ramanan, Athimalaipet V., Modi, Neena, de Wildt, Saskia N., c4c Learning from COVID-19 Group, Aurich, Beate, Bakhtadze, Sophia, Sirvent, Francisco J. Bautista, Cabañas, Fernando, Campbell, Lisa, Casanova, Michaela, Charlton, Philippa, Crandall, Wallace, Eichler, Irmgard, Fregonese, Laura, Hawcutt, Daniel B., Iveli, Pablo, Jaki, Thomas, Jocic-Jakubi, Bosanka, Johnson, Mats, and Kaguelidou, Florentina
- Published
- 2022
- Full Text
- View/download PDF
10. Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study
- Author
-
Duarte-Salles, Talita, primary, Vizcaya, David, additional, Pistillo, Andrea, additional, Casajust, Paula, additional, Sena, Anthony G., additional, Lai, Lana Yin Hui, additional, Prats-Uribe, Albert, additional, Ahmed, Waheed-Ul-Rahman, additional, Alshammari, Thamir M, additional, Alghoul, Heba, additional, Alser, Osaid, additional, Burn, Edward, additional, You, Seng Chan, additional, Areia, Carlos, additional, Blacketer, Clair, additional, DuVall, Scott, additional, Falconer, Thomas, additional, Fernandez-Bertolin, Sergio, additional, Fortin, Stephen, additional, Golozar, Asieh, additional, Gong, Mengchun, additional, Tan, Eng Hooi, additional, Huser, Vojtech, additional, Iveli, Pablo, additional, Morales, Daniel R., additional, Nyberg, Fredrik, additional, Posada, Jose D., additional, Recalde, Martina, additional, Roel, Elena, additional, Schilling, Lisa M., additional, Shah, Nigam H., additional, Shah, Karishma, additional, Suchard, Marc A., additional, Zhang, Lin, additional, Zhang, Ying, additional, Williams, Andrew E., additional, Reich, Christian G., additional, Hripcsak, George, additional, Rijnbeek, Peter, additional, Ryan, Patrick, additional, Kostka, Kristin, additional, and Prieto-Alhambra, Daniel, additional
- Published
- 2020
- Full Text
- View/download PDF
11. Development of a neonatal adverse event severity scale through a Delphi consensus approach
- Author
-
Salaets, Thomas, Turner, Mark A, Short, Mary, Ward, Robert M, Hokuto, Isamu, Ariagno, Ronald L, Klein, Agnes, Beauman, Sandra, Wade, Kelly, Thomson, Merran, Roberts, Eve, Harrison, Judy, Quinn, Theresa, Baer, Gerri, Davis, Jonathan, Allegaert, Karel, Allen, Marilee, Allen, Albert, Freimane, Dina Apele, Aschner, Judy, Ballard, Roberta, Belew, Yodit, Bax, Ralph, Bellflower, Bobby, Bhatt-Mehta, Varsha, Blum, Mike, Bonardi, Chiara, Bondurant, Patti, Boylan, Geraldine, Buracchio, Teresa, Burckart, Gilbert, Burnett, Amber, Burnham, Janelle, Carlson, Cheryl, Chen, Alice, Clay, Bob, Cohen, Alan, Connolly, Eamonn, Connor, Edward, Darsey, Edress, De Lisa, Roberto, Degl, Jennifer, Dempsey, Eugene, Diacovo, Tom, Dionne, Janis, Duchon, Jennifer, Eklund, Wakako, Fabbri, Laura, Fielder, Alistair, Freilich, Emily, Furst-Recktenwald, Sabine, Graham, Tamorah, Green, Dionna, Grogan, Cristal, Heiselman, Darell, Hellstrom, Ann, Herold, Ralf, Hibbs, Anna Maria, Hirschfeld, Steven, Brown, Mary Hise, Holberton, Jim, Iveli, Pablo, Jobe, Alan, Kayton, Allyson, Kenner, Carole, Kraft, Walter, Kusuda, Satoshi, Lacaze, Thierry, Lewis, Tamorah, Lui, Kei, Lutsar, Irja, Mangili, Alexandra, Mangum, Barry, McCune, Susan, McDonald, Karen, McGuire, Courtney, McPherson, Christopher, Miller, Thomas, Ming, Jeffrey, Mitzner, Alison, Modi, Neena, Morrison, Maya, Morsing, Eva, Mulugeta, Lily, Nakamura, Hide, Nelson, Skip, Noel, Gary, Olshansky, Miki, Oschman, Alex, Ozsahin, Hulya, Padula, Mike, Peiris, Vasum, Koplowitz, Luana Pesco, Pham, Josh, Pilon, Aprile, Portman, Ron, Pressler, Ronit, Rabe, Heike, Raju, Tonse, Roepke, Douglas Andrew, Savani, Rashmin, Schnell, Patrick, Segal, Robert, Senterre, Thibault, Shah, Prakesh, Sheridan, Philip, Sherwin, Catherine, Singh, Rajendra, Soll, Roger, Soul, Janet, Spence, Kaye, Storari, Linda, Taminiau, Jan, Tseng, Brian, Van Den Anker, John, Varga, Judy, Venkataraman, Preeti, Vivas, Norma, Walker, Karen, Wilson, Janice, Zajicek, Anne, Zaloga, Gary, Zeldis, Stav, and Pediatrics
- Subjects
medicine.medical_specialty ,Consensus ,severity grading ,drug safety ,Delphi Technique ,Endpoint Determination ,Delphi method ,adverse event ,Severity grading ,macromolecular substances ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,030225 pediatrics ,Medicine ,Humans ,030212 general & internal medicine ,Adverse effect ,computer.programming_language ,Clinical Trials as Topic ,business.industry ,Infant, Newborn ,Age appropriate ,Clinical trial ,Scale (social sciences) ,Pediatrics, Perinatology and Child Health ,Emergency medicine ,Severity Criteria ,Original Article ,neonate ,business ,computer ,Delphi - Abstract
BackgroundAssessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed.MethodsA stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation.ResultsNeonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available.DiscussionThe INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.
- Published
- 2019
12. Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity: Two-Year Efficacy and Safety Outcomes in the Nonrandomized Controlled Trial FIREFLEYE next.
- Author
-
Stahl, Andreas, Nakanishi, Hidehiko, Lepore, Domenico, Wu, Wei-Chi, Azuma, Noriyuki, Jacas, Carlos, Vitti, Robert, Athanikar, Aditya, Chu, Karen, Iveli, Pablo, Zhao, Fei, Leal, Sergio, Schlief, Sarah, Schmelter, Thomas, Miller, Thomas, Köfüncü, Evra, and Fielder, Alistair
- Published
- 2024
- Full Text
- View/download PDF
13. Correction: Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group.
- Author
-
Ramanan, Athimalaipet V., Modi, Neena, de Wildt, Saskia N., Aurich, Beate, Bakhtadze, Sophia, Sirvent, Francisco J. Bautista, Cabañas, Fernando, Campbell, Lisa, Casanova, Michaela, Charlton, Philippa, Crandall, Wallace, Eichler, Irmgard, Fregonese, Laura, Hawcutt, Daniel B., Iveli, Pablo, Jaki, Thomas, Jocic-Jakubi, Bosanka, Johnson, Mats, Kaguelidou, Florentina, and Karadag, Bülent
- Published
- 2023
- Full Text
- View/download PDF
14. Off-label prescriptions in child and adolescent psychiatry. Why, when and how?
- Author
-
Iveli MF, Monti M, Benito ME, and Iveli P
- Subjects
- Adolescent, Humans, Child, Prescriptions, Argentina, Practice Patterns, Physicians', Off-Label Use, Adolescent Psychiatry
- Abstract
In the paediatric population, paticulary in the field of child and adolescent psychiatry, off-label indications are the rule rather than the exception. This may occur when a drug is indicated for a pathology, age, route of administration or treatment length other than those described in the product label. Argentina, unlike other countries, has no explicit regulation on off-label prescribing. Therefore, the prescription of a medicine in a manner different from that approved by the National Administration of Medicines, Food and Medical Technology (ANMAT) does not have a regulatory framework regarding the conditions that must be met at the time of treatment. Although off-label use is not prohibited, it carries an additional risk. In order to encourage research in paediatrics, regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have introduced legislative reform. The following paper will review the current framework of the regulatory agencies that are relevant to the paediatric population and will analyse criteria to guide physicians in the rational use of off-label pharmacotherapy., Competing Interests: The authors have no conflicts of interest to declare., (Creative Commons BY-NC-ND 4.0)
- Published
- 2022
- Full Text
- View/download PDF
15. Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study.
- Author
-
Duarte-Salles T, Vizcaya D, Pistillo A, Casajust P, Sena AG, Lai LYH, Prats-Uribe A, Ahmed WU, Alshammari TM, Alghoul H, Alser O, Burn E, You SC, Areia C, Blacketer C, DuVall S, Falconer T, Fernandez-Bertolin S, Fortin S, Golozar A, Gong M, Tan EH, Huser V, Iveli P, Morales DR, Nyberg F, Posada JD, Recalde M, Roel E, Schilling LM, Shah NH, Shah K, Suchard MA, Zhang L, Zhang Y, Williams AE, Reich CG, Hripcsak G, Rijnbeek P, Ryan P, Kostka K, and Prieto-Alhambra D
- Abstract
Objectives To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children/adolescents diagnosed or hospitalized with COVID-19. Secondly, to describe health outcomes amongst children/adolescents diagnosed with previous seasonal influenza. Design International network cohort. Setting Real-world data from European primary care records (France/Germany/Spain), South Korean claims and US claims and hospital databases. Participants Diagnosed and/or hospitalized children/adolescents with COVID-19 at age <18 between January and June 2020; diagnosed with influenza in 2017-2018. Main outcome measures Baseline demographics and comorbidities, symptoms, 30-day in-hospital treatments and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome (ARDS), multi-system inflammatory syndrome (MIS-C), and death. Results A total of 55,270 children/adolescents diagnosed and 3,693 hospitalized with COVID-19 and 1,952,693 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were all more common among those hospitalized vs diagnosed with COVID-19. The most common COVID-19 symptom was fever. Dyspnea, bronchiolitis, anosmia and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital treatments for COVID-19 included repurposed medications (<10%), and adjunctive therapies: systemic corticosteroids (6.8% to 37.6%), famotidine (9.0% to 28.1%), and antithrombotics such as aspirin (2.0% to 21.4%), heparin (2.2% to 18.1%), and enoxaparin (2.8% to 14.8%). Hospitalization was observed in 0.3% to 1.3% of the COVID-19 diagnosed cohort, with undetectable (N<5 per database) 30-day fatality. Thirty-day outcomes including pneumonia, ARDS, and MIS-C were more frequent in COVID-19 than influenza. Conclusions Despite negligible fatality, complications including pneumonia, ARDS and MIS-C were more frequent in children/adolescents with COVID-19 than with influenza. Dyspnea, anosmia and gastrointestinal symptoms could help differential diagnosis. A wide range of medications were used for the inpatient management of pediatric COVID-19.
- Published
- 2020
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.