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617 results on '"Gibbons, Kristen"'

5. Longitudinal cohort study investigating neurodevelopmental and socioemotional outcomes in school-entry aged children after open heart surgery in Australia and New Zealand: the NITRIC follow-up study protocol.

Author

Long, Debbie, Anderson, Vicki, Crossley, Louise, Sood, Nikita, Charles, Karina, MacDonald, Anna, Bora, Samudragupta, Pestell, Carmela, Murrell, Kathryn, Pride, Natalie, Anderson, Peter, Badawi, Nadia, Rose, Brian, Baillie, Heidi, Masterson, Kate, Chumbes Flores, Jenipher, Sherring, Claire, Raman, Sainath, Beca, John, Erickson, Simon, Festa, Marino, Anderson, Benjamin, Venugopal, Prem, Yim, Deane, Andrews, David, Cheung, Michael, Brizard, Christian, Gentles, Thomas, Iyengar, Ajay, Nicholson, Ian, Ayer, Julian, Butt, Warwick, Schlapbach, Luregn, and Gibbons, Kristen

Subjects
Congenital heart disease, Developmental neurology & neurodisability, Paediatric cardiac surgery, Paediatric cardiology, Paediatric intensive & critical care, Infant, Child, Humans, Aged, Child, Preschool, Follow-Up Studies, Longitudinal Studies, New Zealand, Nitric Oxide, Prospective Studies, Quality of Life, Australia, Cohort Studies, Cardiac Surgical Procedures
Abstract

INTRODUCTION: Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children

Published
2023

9. Machine learning to predict poor school performance in paediatric survivors of intensive care: a population-based cohort study

Author

Gilholm, Patricia, Gibbons, Kristen, Brüningk, Sarah, Klatt, Juliane, Vaithianathan, Rhema, Long, Debbie, and Millar, Johnny

Subjects
Genetic disorders -- Prognosis, High schools -- Analysis, Literacy programs -- Analysis, Machine learning -- Analysis, Hospital patients -- Prognosis, Pediatric intensive care -- Analysis, Health care industry
Abstract

Purpose Whilst survival in paediatric critical care has improved, clinicians lack tools capable of predicting long-term outcomes. We developed a machine learning model to predict poor school outcomes in children surviving intensive care unit (ICU). Methods Population-based study of children < 16 years requiring ICU admission in Queensland, Australia, between 1997 and 2019. Failure to meet the National Minimum Standard (NMS) in the National Assessment Program-Literacy and Numeracy (NAPLAN) assessment during primary and secondary school was the primary outcome. Routine ICU information was used to train machine learning classifiers. Models were trained, validated and tested using stratified nested cross-validation. Results 13,957 childhood ICU survivors with 37,200 corresponding NAPLAN tests after a median follow-up duration of 6 years were included. 14.7%, 17%, 15.6% and 16.6% failed to meet NMS in school grades 3, 5, 7 and 9. The model demonstrated an Area Under the Receiver Operating Characteristic curve (AUROC) of 0.8 (standard deviation SD, 0.01), with 51% specificity to reach 85% sensitivity [relative Area Under the Precision Recall Curve (rel-AUPRC) 3.42, SD 0.06]. Socio-economic status, illness severity, and neurological, congenital, and genetic disorders contributed most to the predictions. In children with no comorbidities admitted between 2009 and 2019, the model achieved a AUROC of 0.77 (SD 0.03) and a rel-AUPRC of 3.31 (SD 0.42). Conclusions A machine learning model using data available at time of ICU discharge predicted failure to meet minimum educational requirements at school age. Implementation of this prediction tool could assist in prioritizing patients for follow-up and targeting of rehabilitative measures., Author(s): Patricia Gilholm [sup.1], Kristen Gibbons [sup.1], Sarah Brüningk [sup.2] [sup.3], Juliane Klatt [sup.2] [sup.3], Rhema Vaithianathan [sup.4], Debbie Long [sup.1] [sup.5], Johnny Millar [sup.6] [sup.7] [sup.8], Wojtek Tomaszewski [sup.4], [...]

Published
2023
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10. Establishing a paediatric critical care core quality measure set using a multistakeholder, consensus-driven process

Author

Schults, Jessica A., Charles, Karina R., Millar, Johnny, Rickard, Claire M., Chopra, Vineet, Lake, Anna, Gibbons, Kristen, Long, Debbie, Rahiman, Sarfaraz, Hutching, Katrina, Winderlich, Jacinta, Spotswood, Naomi E., Johansen, Amy, Secombe, Paul, Pizimolas, Georgina A., Tu, Quyen, Waak, Michaela, Allen, Meredith, McMullan, Brendan, and Hall, Lisa

Published
2024
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11. Host gene expression signatures to identify infection type and organ dysfunction in children evaluated for sepsis: a multicentre cohort study

Author

Levin, Michael, Coin, Lachlan, Gormley, Stuart, Hamilton, Shea, Hoggart, Clive, Kaforou, Myrsini, Sancho-Shimizu, Vanessa, Wright, Victoria, Abdulla, Amina, Agapow, Paul, Bartlett, Maeve, Eleftherohorinou, Hariklia, Galassini, Rachel, Inwald, David, Mashbat, Meg, Menikou, Stephanie, Mustafa, Sobia, Nadel, Simon, Rahman, Rahmeen, Shailes, Hannah, Thakker, Clare, Bokhandi, S., Power, Sue, Barham, Heather, Pathan, N., Ridout, Jenna, White, Deborah, Thurston, Sarah, Faust, S., Patel, S., McCorkell, Jenni, Davies, P., Crate, Lindsey, Navarra, Helen, Carter, Stephanie, Ramaiah, R., Patel, Rekha, Tuffrey, Catherine, Gribbin, Andrew, McCready, Sharon, Peters, Mark, Hardy, Katie, Standing, Fran, O'Neill, Lauren, Abelake, Eugenia, Deep, Akash, Nsirim, Eniola, Pollard, Andrew, Willis, Louise, Young, Zoe, Royad, C., White, Sonia, Fortune, Peter-Marc, Hudnott, Phil, Martinón-Torres, Federico, Salas, Antonio, Álvez González, Fernando, Barral-Arca, Ruth, Cebey-López, Miriam, Curras-Tuala, María José, García, Natalia, García Vicente, Luisa, Gómez-Carballa, Alberto, Gómez Rial, Jose, Grela Beiroa, Andrea, Justicia Grande, Antonio, Leboráns Iglesias, Pilar, Martínez Santos, Alba Elena, Martinón-Torres, Nazareth, Martinón Sánchez, José María, Morillo Gutiérrez, Beatriz, Mosquera Pérez, Belén, Obando Pacheco, Pablo, Pardo-Seco, Jacobo, Pischedda, Sara, Rivero-Calle, Irene, Rodríguez-Tenreiro, Carmen, Redondo-Collazo, Lorenzo, Salas Ellacuriaga, Antonio, Fernández, Sonia Serén, del Sol Porto Silva, María, Vega, Ana, Vilanova Trillo, Lucía, Reyes, Susana Beatriz, Cruz León León, María, Navarro Mingorance, Álvaro, Gabaldó Barrio, Xavier, Oñate Vergara, Eider, Concha Torre, Andrés, Vivanco, Ana, Fernández, Reyes, Giménez Sánchez, Francisco, Sánchez Forte, Miguel, Rojo, Pablo, Contreras, J. Ruiz, Palacios, Alba, Epalza Ibarrondo, Cristina, Fernández Cooke, Elizabeth, Navarro, Marisa, Álvarez Álvarez, Cristina, José Lozano, María, Carreras, Eduardo, Brió Sanagustín, Sonia, Neth, Olaf, Martínez Padilla, Mª del Carmen, Prieto Tato, Luis Manuel, Guillén, Sara, Fernández Silveira, Laura, Moreno, David, de Groot, R., Tutu van Furth, A.M., van der Flier, M., Boeddha, N.P., Driessen, G.J.A., Emonts, M., Hazelzet, J.A., Kuijpers, T.W., Pajkrt, D., Sanders, E.A.M., van de Beek, D., van der Ende, A., Philipsen, H.L.A., Adeel, A.O.A., Breukels, M.A., Brinkman, D.M.C., de Korte, C.C.M.M., de Vries, E., de Waal, W.J., Dekkers, R., Dings-Lammertink, A., Doedens, R.A., Donker, A.E., Dousma, M., Faber, T.E., Gerrits, G.P.J.M., Gerver, J.A.M., Heidema, J., Homan-van der Veen, J., Jacobs, M.A.M., Jansen, N.J.G., Kawczynski, P., Klucovska, K., Kneyber, M.C.J., Koopman-Keemink, Y., Langenhorst, V.J., Leusink, J., Loza, B.F., Merth, I.T., Miedema, C.J., Neeleman, C., Noordzij, J.G., Obihara, C.C., van Overbeek- van Gils, A.L.T., Poortman, G.H., Potgieter, S.T., Potjewijd, J., Rosias, P.P.R., Sprong, T., ten Tussher, G.W., Thio, B.J., Tramper-Stranders, G.A., van Deuren, M., van der Meer, H., van Kuppevelt, A.J.M., van Wermeskerken, A.M., Verwijs, W.A., Wolfs, T.F.W., Schlapbach, Luregn J., Agyeman, Philipp, Aebi, Christoph, Giannoni, Eric, Stocker, Martin, Posfay-Barbe, Klara M., Heininger, Ulrich, Bernhard-Stirnemann, Sara, Niederer-Loher, Anita, Kahlert, Christian, Hasters, Paul, Relly, Christa, Baer, Walter, Berger, Christoph, Carrol, Enitan D., Paulus, Stéphane, Frederick, Hannah, Jennings, Rebecca, Johnston, Joanne, Kenwright, Rhian, Fink, Colin G, Pinnock, Elli, Emonts, Marieke, Agbeko, Rachel, Anderson, Suzanne, Secka, Fatou, Bojang, Kalifa, Sarr, Isatou, Kebbeh, Ngange, Sey, Gibbi, Saidykhan, Momodou, Cole, Fatoumata, Thomas, Gilleh, Antonio, Martin, Zenz, Werner, Kohlfürst, Daniela S., Binder, Alexander, Schweintzger, Nina A., Sagmeister, Manfred, Baumgart, Hinrich, Baumgartner, Markus, Behrends, Uta, Biebl, Ariane, Birnbacher, Robert, Blanke, Jan-Gerd, Boelke, Carsten, Breuling, Kai, Brunner, Jürgen, Buller, Maria, Dahlem, Peter, Dietrich, Beate, Eber, Ernst, Elias, Johannes, Emhofer, Josef, Etschmaier, Rosa, Farr, Sebastian, Girtler, Ylenia, Grigorow, Irina, Heimann, Konrad, Ihm, Ulrike, Jaros, Zdenek, Kalhoff, Hermann, Kaulfersch, Wilhelm, Kemen, Christoph, Klocker, Nina, Köster, Bernhard, Kohlmaier, Benno, Komini, Eleni, Kramer, Lydia, Neubert, Antje, Ortner, Daniel, Pescollderungg, Lydia, Pfurtscheller, Klaus, Reiter, Karl, Ristic, Goran, Rödl, Siegfried, Sellner, Andrea, Sonnleitner, Astrid, Sperl, Matthias, Stelzl, Wolfgang, Till, Holger, Trobisch, Andreas, Vierzig, Anne, Vogel, Ulrich, Weingarten, Christina, Welke, Stefanie, Wimmer, Andreas, Wintergerst, Uwe, Wüller, Daniel, Zaunschirm, Andrew, Ziuraite, Ieva, Žukovskaja, Veslava, Hibberd, Martin L., Davila, Sonia, Delany, Isabel, Schlapbach, Luregn J, Raman, Sainath, Sharp, Nathalie, Phillips, Natalie, Irwin, Adam, Balch, Ross, Harley, Amanda, Johnson, Kerry, Sever, Zoe, George, Shane, Grimwood, Keith, Snelling, Peter J, Chavan, Arjun, Kitcatt, Eleanor, Lawton, Luke, Hempenstall, Allison, Pilot, Pelista, Gibbons, Kristen S, Le Marsney, Renate, Blumenthal, Antje, Ganesamoorthy, Devika, Pardo, Carolyn, Kling, Jessica, McPherson, Stephen, MacDonald, Anna D, Bialasiewicz, Seweryn, Pham, Trang, Wilson, Clare, Sharp, Natalie, Kling, Jessica C, McPherson, Stephen J, Herberg, Jethro A, and Coin, Lachlan J M

Published
2024
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16. Trends in Childhood Oncology Admissions to ICUs in Australia and New Zealand

Author

Wraight, Tracey I., Namachivayam, Siva P., Maiden, Matthew J., Erickson, Simon J., Oberender, Felix, Singh, Puneet, Gard, Jye, Ganeshalingham, Anusha, Millar, Johnny, Ganeshalingam, Anusha, Sherring, Claire, Erickson, Simon, Barr, Samantha, Raman, Sainath, Long, Debbie, Schlapbach, Luregn, Gibbons, Kristen, George, Shane, Singh, Puneet, Smith, Vicky, Butt, Warwick, Delzoppo, Carmel, Millar, Johnny, Gelbart, Ben, Oberender, Felix, Ganu, Subodh, Letton, Georgia, Festa, Marino, and Harper, Gail

Published
2023
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19. Adaptive Clinical Trials in Pediatric Critical Care: A Systematic Review

Author

Gilholm, Patricia, Ergetu, Endrias, Gelbart, Ben, Raman, Sainath, Festa, Marino, Schlapbach, Luregn J., Long, Debbie, Gibbons, Kristen S., Pellegrini, Breanna, George, Shane, Oberender, Felix, Erickson, Simon, Chumbes Flores, Jenipher, Charles, Karina, Waak, Michaela, Butt, Warwick, Delzoppo, Carmel, Masterson, Kate, Millar, Johnny, Ganeshalingam, Anusha, Sherring, Claire, Singh, Puneet, Smith, Vicky, Schults, Jessica, and Darvas, Jennifer

Published
2023
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22. Hemorrhage, Disseminated Intravascular Coagulopathy, and Thrombosis Complications Among Critically Ill Patients with COVID-19: An International COVID-19 Critical Care Consortium Study

Author

Fanning, Jonathon P., Weaver, Natasha, Fanning, Robert B., Griffee, Matthew J., Cho, Sung-Min, Panigada, Mauro, Obonyo, Nchafatso G., Zaaqoq, Akram M., Rando, Hannah, Chia, Yew Woon, Fan, Bingwen Eugene, Sela, Declan, Chiumello, Davide, Coppola, Silvia, Labib, Ahmed, Whitman, Glenn J. R., Arora, Rakesh C., Kim, Bo S., Motos, Anna, Torres, Antoni, Barbé, Ferran, Grasselli, Giacomo, Zanella, Alberto, Etchill, Eric, Usman, Asad Ali, Feth, Maximilian, White, Nicole M., Suen, Jacky Y., Li Bassi, Gianluigi, Peek, Giles J., Fraser, John F., Dalton, Heidi, Al-Dabbous, Tala, Alfoudri, Huda, Shamsah, Mohammed, Elapavaluru, Subbarao, Berg, Ashley, Horn, Christina, Mayasi, Yunis, Schroll, Stephan, Meyer, Dan, Velazco, Jorge, Ploskanych, Ludmyla, Fikes, Wanda, Bagewadi, Rohini, Dao, Marvin, White, Haley, Berrios Laviena, Alondra, Ehlers, Ashley, Shalabi-McGuire, Maysoon, Witt, Trent, Grazioli, Lorenzo, Lorini, Luca, Wilson Grandin, E., Nunez, Jose, Reyes, Tiago, O’Briain, Diarmuid, Hunter, Stephanie, Ramanan, Mahesh, Affleck, Julia, Hurkadli Veerendra, Hemanth, Rai, Sumeet, Russell-Brown, Josie, Nourse, Mary, Joseph, Mark, Mitchell, Brook, Tenzer, Martha, Abe, Ryuzo, Jin Cho, Hwa, Seok Jeong, In, Rahman, Nadeem, Kakar, Vivek, Brozzi, Nicolas, Mehkri, Omar, Krishnan, Sudhir, Duggal, Abhijit, Houltham, Stuart, Graf, Jerónimo, Diaz, Roderigo, Orrego, Roderigo, Delgado, Camila, González, Joyce, Soledad Sanchez, Maria, Piagnerelli, Michael, Valenzuela Sarrazin, Josefa, Zabert, Gustavo, Espinosa, Lucio, Delgado, Paulo, Delgado, Victoria, Rincón, Diego Fernando Bautista, Yanten, Angela Maria Marulanda, Bustamante Duque, Melissa, Brodie, Daniel, Elhazmi, Alyaa, Al-Hudaib, Abdullah, Callahan, Maria, Azhari Taufik, M., Yasmin Wardoyo, Elizabeth, Gunawan, Margaretha, Trisnaningrum, Nurindah S, Irawany, Vera, Rayhan, Muhammad, Panigada, Mauro, Pesenti, Antonio, Zanella, Alberto, Grasselli, Giacomo, Colombo, Sebastiano, Martinet, Chiara, Florio, Gaetano, Antonelli, Massimo, Carelli, Simone, Grieco, Domenico L., Asaki, Motohiro, Hoshino, Kota, Salazar, Leonardo, Monsalve, Mary Alejandra Mendoza, Laffey, John, McNicholas, Bairbre, Cosgrave, David, McCaffrey, Joseph, Bone, Allison, Hakeem, Yusuff, Winearls, James, Tallott, Mandy, Thomson, David, Arnold-Day, Christel, Cupido, Jerome, Fanie, Zainap, Miller, Malcom, Seymore, Lisa, van Straaten, Dawid, Ait Hssain, Ali, Aliudin, Jeffrey, Alqahtani, Al-Reem, Mohamed, Khoulod, Mohamed, Ahmed, Tan, Darwin, Villanueva, Joy, Zaqout, Ahmed, Kurtzman, Ethan, Ademi, Arben, Dobrita, Ana, El Aoudi, Khadija, Segura, Juliet, Giwangkancana, Gezy, Ohshimo, Shinichiro, Osatnik, Javier, Joosten, Anne, Torres, Antoni, Yang, Minlan, Motos, Ana, Luna, Carlos, Arancibia, Francisco, Williams, Virginie, Noel, Alexandre, Luque, Nestor, Fantini, Marina, García, Ruth Noemi Jorge, Chicote Alvarez, Enrique, Greti, Anna, Ceccato, Adrian, Sanchez, Angel, Loza Vazquez, Ana, Roche-Campo, Ferran, Franch-Llasat, Diego, Tuazon, Divina, Amato, Marcelo, Cassimiro, Luciana, Pola, Flavio, Ribeiro, Francis, Fonseca, Guilherme, Dalton, Heidi, Desai, Mehul, Osborn, Erik, Deeb, Hala, Arcadipane, Antonio, Martucci, Gennaro, Panarello, Giovanna, Vitiello, Chiara, Bianco, Claudia, Occhipinti, Giovanna, Rossetti, Matteo, Cuffaro, Raffaele, Cho, Sung-Min, Whitman, Glenn, Shimizu, Hiroaki, Moriyama, Naoki, Kim, Jae-Burm, Kitamura, Nobuya, Gebauer, Johannes, Yokoyama, Toshiki, Al-Fares, Abdulrahman, Buabbas, Sarah, Alamad, Esam, Alawadhi, Fatma, Alawadi, Kalthoum, Tanaka, Hiro, Hashimoto, Satoru, Yamazaki, Masaki, Oh, Tak-Hyuck, Epler, Mark, Forney, Cathleen, Kruse, Louise, Feister, Jared, Williamson, Joelle, Grobengieser, Katherine, Gnall, Eric, Golden, Sasha, Caroline, Mara, Shapiro, Timothy, Karaj, Colleen, Thome, Lisa, Sher, Lynn, Vanderland, Mark, Welch, Mary, McDermott, Sherry, Brain, Matthew, Mineall, Sarah, Kimura, Dai, Brazzi, Luca, Sales, Gabriele, Montrucchio, Giorgia, Ogston, Tawnya, Nagpal, Dave, Fischer, Karlee, Lorusso, Roberto, Rangappa, Rajavardhan, Rai, Sujin, Appu, Argin, Esperatti, Mariano, Angélica Fuentes, Nora, Eugenia Gonzalez, Maria, O’Briain, Diarmuid, Carton, Edmund G., Sen, Ayan, Palacios, Amanda, Rainey, Deborah, Samoukoviv, Gordan, Campisi, Josie, Durham, Lucia, Neumann, Emily, Seefeldt, Cassandra, Falcucci, Octavio, Emmrich, Amanda, Guy, Jennifer, Johns, Carling, Potzner, Kelly, Zimmermann, Catherine, Espinal, Angelia, Buchtele, Nina, Schwameis, Michael, Korhnfehl, Andrea, Brock, Roman, Staudinger, Thomas, Stecher, Stephanie-Susanne, Barnikel, Michaela, Antón, Sófia, Pawlikowski, Alexandra, Zaaqoq, Akram, Anh Galloway, Lan, Merley, Caitlin, Nichol, Alistair, Csete, Marc, Quesada, Luisa, Saba, Isabela, Kasugai, Daisuke, Hiraiwa, Hiroaki, Tanaka, Taku, Marwali, Eva, Purnama, Yoel, Rahayu Dewayanti, Santi, Ardiyan, Arifa Juzar, Dafsah, Siagian, Debby, Chen, Yih-Sharng, Ogino, Mark, Ratsep, Indrek, Post, Andra-Maris, Sillaots, Piret, Krund, Anneli, Lehiste, Merili-Helen, Lepik, Tanel, Manetta, Frank, Mihelis, Effe, Claire Sarmiento, Iam, Narasimhan, Mangala, Varrone, Michael, Komats, Mamoru, Garcia-Diaz, Julia, Harmon, Catherine, Veena Satyapriya, S., Bhatt, Amar, Mokadam, Nahush A., Uribe, Alberto, Gonzalez, Alicia, Shi, Haixia, McKeown, Johnny, Pasek, Joshua, Fiorda, Juan, Echeverria, Marco, Moreno, Rita, Zakhary, Bishoy, Cavana, Marco, Cucino, Alberto, Foti, Giuseppe, Giani, Marco, Fumagalli, Benedetta, Chiumello, Davide, Castagna, Valentina, Dell’Amore, Andrea, Navalesi, Paolo, Shum, Hoi-Ping, Vuysteke, Alain, Usman, Asad, Acker, Andrew, Smood, Benjamin, Mergler, Blake, Sertic, Federico, Subramanian, Madhu, Sperry, Alexandra, Rizer, Nicolas, Burhan, Erlina, Rasmin, Menaldi, Akmal, Ernita, Sitompul, Faya, Lolong, Navy, Naivedh, Bhat, Erickson, Simon, Barrett, Peter, Dean, David, Daugherty, Julia, Loforte, Antonio, Khan, Irfan, Abraar Quraishi, Mohammed, DeSantis, Olivia, So, Dominic, Kandamby, Darshana, Mandei, Jose M., Natanael, Hans, YudhaLantang, Eka, Lantang, Anastasia, Oto Wijaya, Surya, Jung, Anna, Ng, George, Yiu Ng, Wing, Yeung Ng, Pauline, Fang, Shu, Tabah, Alexis, Ratcliffe, Megan, Duroux, Maree, Adachi, Shingo, Nakao, Shota, Blanco, Pablo, Prieto, Ana, Sánchez, Jesús, Nicholson, Meghan, Butt, Warwick, Serratore, Alyssa, Delzoppo, Carmel, Janin, Pierre, Yarad, Elizabeth, Totaro, Richard, Coles, Jennifer, Pujo, Bambang, Balk, Robert, Vissing, Andy, Kapania, Esha, Hays, James, Fox, Samuel, Yantosh, Garrett, Mishin, Pavel, Yuliarto, Saptadi, Hari Santoso, Kohar, Djajalaksana, Susanthy, Zainul Fatoni, Arie, Fukuda, Masahiro, Liu, Keibun, Pelosi, Paolo, Battaglini, Denise, Masa Jiménez, Juan Fernando, Bastos, Diego, Gaião, Sérgio, Rusmawatiningtyas, Desy, Cho, Young-Jae, Hwan Lee, Su, Kawasaki, Tatsuya, Munshi, Laveena, Sakiyalak, Pranya, Nitayavardhana, Prompak, Seitz, Tamara, Arora, Rakesh, Kent, David, Marino, Daniel, Parwar, Swapnil, Cheng, Andrew, Miller, Jennene, Fujitani, Shigeki, Shimizu, Naoki, Madhok, Jai, Owyang, Clark, Buscher, Hergen, Reynolds, Claire, Maasikas, Olavi, Beljantsev, Aleksan, Mihnovits, Vladislav, Akimoto, Takako, Aizawa, Mariko, Horibe, Kanako, Onodera, Ryota, Hodgson, Carol, Burrell, Aidan, Young, Meredith, George, Timothy, Shekar, Kiran, McGuinness, Niki, Irvine, Lacey, Flynn, Brigid, Endo, Tomoyuki, Sugiyama, Kazuhiro, Shimizu, Keiki, Fan, Eddy, Exconde, Kathleen, Ichiba, Shingo, Lussier, Leslie, Lotz, Gösta, Malfertheiner, Maximilian, Maier, Lars, Dreier, Esther, Permata Kusumastuti, Neurinda, McCloskey, Colin, Dabaliz, Al-Awwab, Elshazly, Tarek B, Smith, Josiah, Szuldrzynski, Konstanty S., Bielański, Piotr, Hakeem, Yusuff, Wille, Keith, Murthy, Srinivas, Parhar, Ken Kuljit S., Fiest, Kirsten M., Codan, Cassidy, Shahid, Anmol, Fayed, Mohamed, Evans, Timothy, Garcia, Rebekah, Gutierrez, Ashley, Shimizu, Hiroaki, Song, Tae, Rose, Rebecca, Bennett, Suzanne, Richardson, Denise, Peek, Giles, Arora, Lovkesh, Rappapport, Kristina, Rudolph, Kristina, Sibenaller, Zita, Stout, Lori, Walter, Alicia, Herr, Daniel, Vedadi, Nazli, Bartlett, Robert, Pesenti, Antonio, Thompson, Shaun, Hoffman, Julie, Ying, Xiaonan, Kennedy, Ryan, Elhadi, Muhammed, Griffee, Matthew, Ciullo, Anna, Kida, Yuri, Ferrer Roca, Ricard, Riera, JordI, Contreras, Sofia, Alegre, Cynthia, Kay, Christy, Fischer, Irene, Renner, Elizabeth, Taniguci, Hayato, Fraser, John, Li Bassi, Gianluigi, Suen, Jacky, Barnett, Adrian, White, Nicole, Gibbons, Kristen, Forsyth, Simon, Corley, Amanda, Pearse, India, Hinton, Samuel, Abbate, Gabriella, Hassan, Halah, Heinsar, Silver, Karnik, Varun A, Ki, Katrina, O’Neill, Hollier F., Obonyo, Nchafatso, Pretti Pimenta, Leticia, Reid, Janice D., Sato, Kei, Shekar, Kiran, Vuorinen, Aapeli, Wildi, Karin S., Wilson, Emily S., Yerkovich, Stephanie, Lee, James, Plotkin, Daniel, Wanjiru Citarella, Barbara, Merson, Laura, Hartley, Emma, Lubis, Bastian, Ikeyama, Takanari, Bhaskar, Balu, Jung, Jae-Seung, McGuinness, Shay, Eastwood, Glenn, Rossi Marta, Sandra, Guarracino, Fabio, Gerle, Stacy, Coxon, Emily, Claro, Bruno, Loverde, Daniel, Patil, Namrata, Parrini, Vieri, McBride, Angela, Negaard, Kathryn, Ratsch, Angela, Abdelaziz, Ahmad, David Uribe, Juan, Peris, Adriano, Sanders, Mark, Emerson, Dominic, Kamal, Muhammad, Povoa, Pedro, Francis, Roland, Cherif, Ali, Joseph, Sunimol, Di Nardo, Matteo, Heard, Micheal, Kyle, Kimberly, Blackwell, Ray A, Piagnerelli, Michael, Biston, Patrick, Won Jeong, Hye, Smith, Reanna, Prawira, Yogi, Montrucchio, Giorgia, Huerta Garcia, Arturo, Salterain, Nahikari, Meyns, Bart, Moreno, Marsha, Walia, Rajat, Mehta, Amit, Schweda, Annette, Supriatna, Moh, Kirakli, Cenk, Williams, Melissa, Hoon Kim, Kyung, Assad, Alexandra, Giraldo, Estefania, Karolak, Wojtek, Balik, Martin, Pocock, Elizabeth, Gajkowski, Evan, Masafumi, Kanamoto, Barrett, Nicholas, Takeyama, Yoshihiro, Park, Sunghoon, Amin, Faizan, Meilyana Andriyani, Fina, Sudakevych, Serhii, Ratsch, Angela, Vera, Magdalena, Cornejo, Rodrigo, Schwarz, Patrícia, Carolina Mardini, Ana, de Paula, Thais, Serpa Neto, Ary, Villoldo, Andrea, Siciliano Colafranceschi, Alexandre, Ubeda Iglesias, Alejandro, Granjean, Juan, Melro, Lívia Maria Garcia, Fioravante Romualdo, Giovana, Gaia, Diego, Souza, Helmgton, Galas, Filomena, Máñez Mendiluce, Rafael, Sosa, Alejandra, Martinez, Ignacio, Kurosawa, Hiroshi, Salgado, Juan, Hugi-Mayr, Beate, Charbonneau, Eric, Salvatore Barzilai, Vitor, Monteiro, Veronica, Ribeiro de Souza, Rodrigo, Harper, Michael, Suzuki, Hiroyuki, Adams, Celina, Brieva, Jorge, Nyale, George, Saleem Eltatar, Faisal, Fatani, Jihan, Baeissa, Husam, Masri, Ayman AL, Rabie, Ahmed, Yee Hui, Mok, Yamane, Masahiro, Jung, Hanna, Mojisola Margaret, Ayorinde, Nacpil, Newell, Ruck, Katja, Bakken, Rhonda, Jara, Claire, Felton, Tim, Berra, Lorenzo, Shah, Bobby, Chakraborty, Arpan, Cardona, Monika, Capatos, Gerry, Akkanti, Bindu, Orija, Abiodun, Jain, Harsh, Ito, Asami, Housni, Brahim, Low, Sennen, Iihara, Koji, Chavez, Joselito, Ramanathan, Kollengode, Zabert, Gustavo, Naidoo, Krubin, Seppelt, Ian, VanDyk, Marlice, MacDonald, Sarah, Ichiba, Shingo, McGregor, Randy, Siebenaler, Teka, Flynn, Hannah, Lofton, Kristi, Aokage, Toshiyuki, Shigemitsu, Kazuaki, Moscatelli, Andrea, Fiorentino, Giuseppe, Baumgaertel, Matthias, Eddy, Serge, Assy, Jana, Hutahaean, Amelya, Roush, Holly, Sichting, Kay A, Alessandri, Francesco, Burns, Debra, Rabie, Ahmed, Salt, Gavin, Garabedian, Carl P., Millar, Jonathan, Sim, Malcolm, Mattke, Adrian, McAuley, Danny, Tadili, Jawad, Frenzel, Tim, Bar-Lavie, Yaron, Blandino Ortiz, Aaron, Stone, Jackie, Tabah, Alexis, Attokaran, Antony, Farquharson, Michael, Patel, Brij, Gunning, Derek, Baillie, Kenneth, Watson, Pia, Tamai, Kenji, Ketut Sajinadiyasa, Gede, Kanyawati, Dyah, Salgado, Marcello, Sassine, Assad, Yudo, Bhirowo, McCaul, Scott, Lee, Bongjin, Min Lee, Sang, Afek, Arnon, Iwashita, Yoshiaki, Pujo Semedi, Bambang, Permata Kusumastuti, Neurinda, Metiva, Jack, Van Belle, Nicole, Martin-Loeches, Ignacio, Ivatt, Lenny, Yew Woon, Chia, Mi Kang, Hyun, Smith, Timothy, James, Erskine, Al-Rawas, Nawar, Iwasaki, Yudai, Chan King-Chung, Kenny, Gudzenko, Vadim, Hugi-Mayr, Beate, Taccone, Fabio, Perdhana, Fajar, Lamarche, Yoan, Miguel Ribeiro, Joao, Bradic, Nikola, Van den Bossche, Klaartje, Lansink, Oude, Singh, Gurmeet, Debeuckelaere, Gerdy, Stelfox, Henry T., Yi, Cassia, Elia, Jennifer, Tribble, Thomas, Shankar, Shyam, Padmanabhan, Raj, Hallinan, Bill, Paoletti, Luca, Leyva, Yolanda, Fykuda, Tatuma, Badulak, Jenelle, Koch, Jillian, Hackman, Amy, Janowaik, Lisa, Hernandez, Deb, Osofsky, Jennifer, Donadello, Katia, Lawang, Aizah, Fine, Josh, Davidson, Benjamin, and Vazquez, Andres Oswaldo Razo

Published
2023
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26. Early short course of neuromuscular blocking agents in patients with COVID-19 ARDS: a propensity score analysis

Author

Li Bassi, Gianluigi, Gibbons, Kristen, Suen, Jacky Y., Dalton, Heidi J., White, Nicole, Corley, Amanda, Shrapnel, Sally, Hinton, Samuel, Forsyth, Simon, Laffey, John G., Fan, Eddy, Fanning, Jonathon P., Panigada, Mauro, Bartlett, Robert, Brodie, Daniel, Burrell, Aidan, Chiumello, Davide, Elhazmi, Alyaa, Esperatti, Mariano, Grasselli, Giacomo, Hodgson, Carol, Ichiba, Shingo, Luna, Carlos, Marwali, Eva, Merson, Laura, Murthy, Srinivas, Nichol, Alistair, Ogino, Mark, Pelosi, Paolo, Torres, Antoni, Ng, Pauline Yeung, and Fraser, John F.

Published
2022
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27. Pediatric Thromboelastograph 6s and Laboratory Coagulation Reference Values

Author

Moynihan, Katie M., Johnson, Kerry, Rane, Mark, Norman, Andrew, Humphreys, Susan, Stocker, Christian, Gibbons, Kristen, and Roy, John

Subjects
Blood coagulation tests -- Methods -- Demographic aspects, Reference values (Medicine) -- Research, Pediatric research, Diagnosis, Laboratory -- Methods, Health
Abstract

Context.--Specific reference intervals (RIs) facilitate accurate interpretation of results. Coagulation assay results may vary by demographics and also between reagents and analyzers used. Current Thromboelastograph 6s (TEG 6s) Hemostasis Analyzer RIs were generated from adult samples. Objective.--To generate reagent analyzer-specific pediatric RIs for TEG 6s and coagulation parameters. Design.--A prospective, observational, single-center study of healthy children undergoing general anesthesia (January 3, 2017 to January 3, 2019). Venous blood samples were obtained for TEG 6s (Kaolin, Kaolin-Heparinase, Rapid and Functional Fibrinogen assays) and coagulation parameters (activated partial thromboplastin time, prothrombin time, thrombin clotting time, Echis time, antithrombin activity, and fibrinogen concentration using Instrumentation Laboratory ACL-TOP analyzers). Differences between activated partial thromboplastin time and prothrombin time reagents were investigated using mixed-effects regression, comparing maximum coefficients-of-variation with assay-specific allowable variation. RIs (lower/upper limits 2.5th of 97.5th percentiles) were generated using the following 2 methods: within discrete age-groups (neonates [ Results.--Variation between prothrombin time and activated partial thromboplastin time assays using different reagents was clinically significant. Reagent-analyzer specific pediatric RIs were generated using data from 254 children. Discrete and model-based RIs varied by age for all coagulation parameters and TEG 6s variables in all assays. Conclusions.--We report reagent-analyzer specific pediatric RIs for TEG 6s and coagulation parameters. Observed variation reinforces recommendations for laboratory-specific RIs. These findings improve accuracy of interpretation of clinical results, provide a foundation for comparison and validation of tests in pathology, and illustrate feasibility and advantages of model-based RI approaches. (Arch Pathol Lab Med. 2021;145:1413-1423; doi: 10.5858/arpa.2020-0647-OA), Reference intervals (RIs) are generally defined as the 95% CIs from a healthy population where lower and upper limits are 2.5th and 97.5th percentiles, respectively. (1-3) Accurate RIs for the [...]

Published
2021
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30. Provision of continuous renal replacement therapy in children in intensive care in Australia and New Zealand

Author

Killick, Caroline J., Oberender, Felix, Ganu, Subodh, Gibbons, Kristen, Agarwal, Sidharth, Chiletti, Roberto, Erickson, Simon, Jackson, Hamish, Numa, Andrew, Plumpton, Kevin, Wiseman, Greg, Nakazawa, Kiraka, Ganu, Subodh, and Hunter, John

Abstract

The objective of this study was to describe current use, clinical practice, and outcomes of continuous renal replacement therapy (CRRT) in children in the intensive care unit (ICU) in Australia and New Zealand.

Published
2024
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31. Statistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial

Author

Gibbons, Kristen S., Schlapbach, Luregn J., Horton, Stephen B., Long, Debbie A., Beca, John, Erickson, Simon, Festa, Marino, d’Udekem, Yves, Alphonso, Nelson, Winlaw, David, Johnson, Kerry, Delzoppo, Carmel, van Loon, Kim, Gannon, Brenda, Fooken, Jonas, Blumenthal, Antje, Young, Paul J., Butt, Warwick, and Schibler, Andreas

Published
2021
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32. Serum Levels of Vitamin C and Thiamin in Children With Suspected Sepsis: A Prospective Observational Cohort Study

Author

McWhinney, Brett, Ungerer, Jacobus, LeMarsey, Renate, Phillips, Natalie, Raman, Sainath, Gibbons, Kristen, Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598, McWhinney, Brett, Ungerer, Jacobus, LeMarsey, Renate, Phillips, Natalie, Raman, Sainath, Gibbons, Kristen, and Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598

Abstract

OBJECTIVES: Vitamin C and thiamin have been trialed as adjunctive therapies in adults with septic shock but their role in critically ill children is unclear. We assessed serum levels of vitamin C and thiamin in children evaluated for sepsis. DESIGN: Single-center prospective observational study. Serum levels of vitamin C and thiamin were measured on admission and association with multiple organ dysfunction syndrome (MODS) was explored using logistic regression. SETTING: Emergency department and PICU in a tertiary children’s hospital, Queensland, Australia. PATIENTS: Children greater than 1 month and less than 17 years evaluated for sepsis. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: Vitamin levels were determined in 221 children with a median age of 3.5 (interquartile range [IQR] 1.6, 8.3) years. Vitamin C levels were inversely correlated with severity as measured by pediatric Sequential Organ Failure Assessment (Spearman’s rho = –0.16, p = 0.018). Median (IQR) vitamin C levels on admission were 35.7 (17.9, 54.1) µmol/L, 36.1 (21.4, 53.7) µmol/L, and 17.9 (6.6, 43.0) µmol/L in children without organ dysfunction, single organ dysfunction, and MODS, respectively (p = 0.017). In multivariable analyses, low levels of vitamin C at the time of sampling were associated with greater odds of MODS (adjusted odds ratio [aOR] 3.04; 95% CI, 1.51–6.12), and vitamin C deficiency was associated with greater odds of MODS at 24 hours after sampling (aOR 3.38; 95% CI, 1.53–7.47). Median (IQR) thiamin levels were 162 (138, 192) nmol/L, 185 (143, 200) nmol/L, and 136 (110, 179) nmol/L in children without organ dysfunction, single organ dysfunction, and MODS, respectively (p = 0.061). We failed to identify an association between thiamin deficiency and either MODS at sampling (OR 2.52; 95% CI, 0.15–40.86) or MODS at 24 hours (OR 2.96; 95% CI, 0.18–48.18). CONCLUSIONS: Critically ill children evaluated for sepsis frequently manifest decreased levels of vitamin C, with low

Published
2024

33. Resuscitation With Early Adrenaline Infusion for Children With Septic Shock: A Randomized Pilot Trial

Author

Harley, Amanda, George, Shane, Phillips, Natalie, King, Megan, Long, Debbie, Keijzers, Gerben, Lister, Paula, Raman, Sainath, Bellomo, Rinaldo, Gibbons, Kristen, Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598, Harley, Amanda, George, Shane, Phillips, Natalie, King, Megan, Long, Debbie, Keijzers, Gerben, Lister, Paula, Raman, Sainath, Bellomo, Rinaldo, Gibbons, Kristen, and Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598

Abstract

OBJECTIVES: In children with septic shock, guidelines recommend resuscitation with 40–60 mL/kg of fluid boluses, yet there is a lack of evidence to support this practice. We aimed to determine the feasibility of a randomized trial comparing early adrenaline infusion with standard fluid resuscitation in children with septic shock. DESIGN: Open-label parallel randomized controlled, multicenter pilot study. The primary end point was feasibility; the exploratory clinical endpoint was survival free of organ dysfunction by 28 days. SETTING: Four pediatric Emergency Departments in Queensland, Australia. PATIENTS: Children between 28 days and 18 years old with septic shock. INTERVENTIONS: Patients were assigned 1:1 to receive a continuous adrenaline infusion after 20 mL/kg fluid bolus resuscitation (n = 17), or standard care fluid resuscitation defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to inotrope commencement (n = 23). MEASUREMENTS AND MAIN RESULTS: Forty of 58 eligible patients (69%) were consented with a median age of 3.7 years (interquartile range [IQR], 0.9–12.1 yr). The median time from randomization to inotropes was 16 minutes (IQR, 12–26 min) in the intervention group, and 49 minutes (IQR, 29–63 min) in the standard care group. The median amount of fluid delivered during the first 24 hours was 0 mL/kg (IQR, 0–10.0 mL/kg) in the intervention group, and 20.0 mL/kg (14.6–28.6 mL/kg) in the standard group (difference, –20.0; 95% CI, –28.0 to –12.0). The number of days alive and free of organ dysfunction did not differ between the intervention and standard care groups, with a median of 27 days (IQR, 26–27 d) versus 26 days (IQR, 25–27 d). There were no adverse events reported associated with the intervention. CONCLUSIONS: In children with septic shock, a protocol comparing early administration of adrenaline versus standard care achieved separation between the study arms in relation to inotrope and fluid bolus use.

Published
2024

34. Resuscitation With Vitamin C, Hydrocortisone, and Thiamin in Children With Septic Shock: A Multicenter Randomized Pilot Study

Author

Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598, Raman, Sainath, Buckley, David, George, Shane, King, Megan, Ridolfi, Roberta, Harley, Amanda, Cree, Michele, Long, Debbie, Erickson, Simon, Singh, Puneet, Festa, Marino, Gibbons, Kristen, Bellomo, Rinaldo, Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598, Raman, Sainath, Buckley, David, George, Shane, King, Megan, Ridolfi, Roberta, Harley, Amanda, Cree, Michele, Long, Debbie, Erickson, Simon, Singh, Puneet, Festa, Marino, Gibbons, Kristen, and Bellomo, Rinaldo

Abstract

OBJECTIVES: Adjunctive therapy with vitamin C, hydrocortisone, and thiamin has been evaluated in adults, but randomized controlled trial (RCT) data in children are lacking. We aimed to test the feasibility of vitamin C, hydrocortisone, and thiamin in PICU patients with septic shock; and to explore whether the intervention is associated with increased survival free of organ dysfunction. DESIGN: Open-label parallel, pilot RCT multicenter study. The primary endpoint was feasibility. Clinical endpoints included survival free of organ dysfunction censored at 28 days and nine secondary outcomes, shock reversal, and two proxy measures of intervention efficacy. SETTING: Six PICUs in Australia and New Zealand. PATIENTS: Children of age between 28 days and 18 years requiring vasoactive drugs for septic shock between August 2019 and March 2021. INTERVENTIONS: Patients were assigned 1:1 to receive 1 mg/kg hydrocortisone every 6 hours (q6h), 30 mg/kg ascorbic acid q6h, and 4 mg/kg thiamin every 12 hours (n = 27), or standard septic shock management (n = 33). MEASUREMENTS AND MAIN RESULTS: Sixty of 77 (78%) eligible patients consented with 91% of approached parents providing consent. The median time from randomization to intervention was 44 (interquartile range [IQR] 29–120) min. Seventy of seventy-seven (28%) patients had received IV steroids before randomization. Median survival alive and free of organ dysfunction was 20.0 (0.0–26.0) days in the intervention and 21.0 (0.0–25.0) days in the standard care group. Median PICU length of stay was 5.3 (2.5–11.3) days in the intervention group versus 6.9 (3.0–11.5) days in the control group. Shock reversal occurred at a median of 35.2 (14.6–101.2) hours in the intervention group versus 47.3 (22.4–106.8) hours in the standard care group (median difference –12 hr; 95% CI, –56.8 to 32.7 hr). CONCLUSIONS: In children requiring vasopressors for septic shock, a protocol comparing adjunctive treatment with high-dose vitamin C, hydrocortisone

Published
2024

35. Long‐term outcomes after paediatric sepsis (LOTUS)–A protocol for an Australian cohort study

Author

Minogue, Jessicah; https://orcid.org/0000-0001-6551-9098, Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598, Keogh, Samantha; https://orcid.org/0000-0002-2797-4388, Gibbons, Kristen; https://orcid.org/0000-0002-5679-0932, Long, Debbie; https://orcid.org/0000-0002-0984-9559, Minogue, Jessicah; https://orcid.org/0000-0001-6551-9098, Schlapbach, Luregn J; https://orcid.org/0000-0003-2281-2598, Keogh, Samantha; https://orcid.org/0000-0002-2797-4388, Gibbons, Kristen; https://orcid.org/0000-0002-5679-0932, and Long, Debbie; https://orcid.org/0000-0002-0984-9559

Abstract

Background: Globally, sepsis has been identified as one of the leading causes of preventable childhood mortality and morbidity. Previous studies on intensive care patients estimated that approximately 30% of children with sepsis experience some form of disability at discharge. Development of care has seen growing numbers of children treated for sepsis not requiring a PICU admission; however, outcomes in this population are yet to be understood. Further focus is required to understand sepsis survivorship across the wider population to address knowledge gaps and morbidity burden in the broader surviving population. Aims: To assess the cognitive, physical, emotional and social health of children surviving sepsis 2 years after hospital discharge. Study design: A prospective, observational cohort study. Results: Two hundred and thirty-two children will be screened, 2 years after their hospital admission, and approached for participation in this study. Children who are <18 years of age at follow-up, treated for sepsis-related organ dysfunction or septic shock in Queensland between October 2018 and December 2019, will be included. Children who are deceased at follow-up, under care of the state, or require English interpreters will be excluded from participation. Data will be collected through an online follow-up survey comprising validated caregiver-reported questionnaires covering the four Post Intensive Care Syndrome-paediatrics (PICS-p) domains (cognitive, physical, emotional and social health; Manning et al. Pediatr Crit Care Med, 2018, 19, 298-300). The primary outcome is an adaptive behaviour of the participants assessed using the Vinelands-3 tool. Secondary outcomes will include neurodevelopment, quality of life, child distress, overall function, executive function, caregiver's distress and caregiver's stress. Analysis of variance (ANOVA), Kruskal-Wallis and Fisher's exact test/chi-squared tests will be used for statistical analyses. No adjustments will be made for

Published
2024

36. Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial.

Author

Le Marsney, Renate, Johnson, Kerry, Chumbes Flores, Jenipher, Coetzer, Shelley, Darvas, Jennifer, Delzoppo, Carmel, Jolly, Arielle, Masterson, Kate, Sherring, Claire, Thomson, Hannah, Ergetu, Endrias, Gilholm, Patricia, and Gibbons, Kristen S

Subjects
DATA security, RISK assessment, DATABASES, DATABASE management, SECONDARY analysis, RESEARCH funding, STATISTICAL sampling, LOGISTIC regression analysis, DESCRIPTIVE statistics, CORONARY artery bypass, SIMULATION methods in education, INTENSIVE care units, HEALTH outcome assessment, CONFIDENCE intervals, TIME, REGRESSION analysis
Abstract

Background/Aims: Regulatory guidelines recommend that sponsors develop a risk-based approach to monitoring clinical trials. However, there is a lack of evidence to guide the effective implementation of monitoring activities encompassed in this approach. The aim of this study was to assess the efficiency and impact of the risk-based monitoring approach used for a multicentre randomised controlled trial comparing treatments in paediatric patients undergoing cardiac bypass surgery. Methods: This is a secondary analysis of data from a randomised controlled trial that implemented targeted source data verification as part of the risk-based monitoring approach. Monitoring duration and source to database error rates were calculated across the monitored trial dataset. The monitored and unmonitored trial dataset, and simulated trial datasets with differing degrees of source data verification and cohort sizes were compared for their effect on trial outcomes. Results: In total, 106,749 critical data points across 1,282 participants were verified from source data either remotely or on-site during the trial. The total time spent monitoring was 365 hours, with a median (interquartile range) of 10 (7, 16) minutes per participant. An overall source to database error rate of 3.1% was found, and this did not differ between treatment groups. A low rate of error was found for all outcomes undergoing 100% source data verification, with the exception of two secondary outcomes with error rates >10%. Minimal variation in trial outcomes were found between the unmonitored and monitored datasets. Reduced degrees of source data verification and reduced cohort sizes assessed using simulated trial datasets had minimal impact on trial outcomes. Conclusions: Targeted source data verification of data critical to trial outcomes, which carried with it a substantial time investment, did not have an impact on study outcomes in this trial. This evaluation of the cost-effectiveness of targeted source data verification contributes to the evidence-base regarding the context where reduced emphasis should be placed on source data verification as the foremost monitoring activity. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Comparison of carbon dioxide control during pressure controlled versus pressure regulated volume controlled ventilation in children (CoCO2): protocol for a pilot digital randomized controlled trial

Author

Mozun, Rebeca, primary, Chopard, Daphne, additional, Zapf, Florian, additional, Baumann, Philipp, additional, Brotschi, Barbara, additional, Adam, Anika, additional, Jaegi, Vera, additional, Bangerter, Beat, additional, Gibbons, Kristen, additional, Burren, Juerg, additional, and Schlapbach, Luregn J, additional

Published
2024
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41. Host gene expression signatures to identify infection type and organ dysfunction in children evaluated for sepsis: a multicentre cohort study

Author

Schlapbach, Luregn J, Ganesamoorthy, Devika, Wilson, Clare, Raman, Sainath, George, Shane, Snelling, Peter J, Phillips, Natalie, Irwin, Adam, Sharp, Natalie, Le Marsney, Renate, Chavan, Arjun, Hempenstall, Allison, Bialasiewicz, Seweryn, MacDonald, Anna D, Grimwood, Keith, Kling, Jessica C, McPherson, Stephen J, Blumenthal, Antje, Kaforou, Myrsini, Levin, Michael, Herberg, Jethro A, Gibbons, Kristen S, Coin, Lachlan J M, Levin, Michael, Coin, Lachlan, Gormley, Stuart, Hamilton, Shea, Hoggart, Clive, Kaforou, Myrsini, Sancho-Shimizu, Vanessa, Wright, Victoria, Abdulla, Amina, Agapow, Paul, Bartlett, Maeve, Eleftherohorinou, Hariklia, Galassini, Rachel, Inwald, David, Mashbat, Meg, Menikou, Stephanie, Mustafa, Sobia, Nadel, Simon, Rahman, Rahmeen, Shailes, Hannah, Thakker, Clare, Bokhandi, S., Power, Sue, Barham, Heather, Pathan, N., Ridout, Jenna, White, Deborah, Thurston, Sarah, Faust, S., Patel, S., McCorkell, Jenni, Davies, P., Crate, Lindsey, Navarra, Helen, Carter, Stephanie, Ramaiah, R., Patel, Rekha, Tuffrey, Catherine, Gribbin, Andrew, McCready, Sharon, Peters, Mark, Hardy, Katie, Standing, Fran, O'Neill, Lauren, Abelake, Eugenia, Deep, Akash, Nsirim, Eniola, Pollard, Andrew, Willis, Louise, Young, Zoe, Royad, C., White, Sonia, Fortune, Peter-Marc, Hudnott, Phil, Martinón-Torres, Federico, Salas, Antonio, Álvez González, Fernando, Barral-Arca, Ruth, Cebey-López, Miriam, Curras-Tuala, María José, García, Natalia, García Vicente, Luisa, Gómez-Carballa, Alberto, Gómez Rial, Jose, Grela Beiroa, Andrea, Justicia Grande, Antonio, Leboráns Iglesias, Pilar, Martínez Santos, Alba Elena, Martinón-Torres, Nazareth, Martinón Sánchez, José María, Morillo Gutiérrez, Beatriz, Mosquera Pérez, Belén, Obando Pacheco, Pablo, Pardo-Seco, Jacobo, Pischedda, Sara, Rivero-Calle, Irene, Rodríguez-Tenreiro, Carmen, Redondo-Collazo, Lorenzo, Salas Ellacuriaga, Antonio, Fernández, Sonia Serén, del Sol Porto Silva, María, Vega, Ana, Vilanova Trillo, Lucía, Reyes, Susana Beatriz, Cruz León León, María, Navarro Mingorance, Álvaro, Gabaldó Barrio, Xavier, Oñate Vergara, Eider, Concha Torre, Andrés, Vivanco, Ana, Fernández, Reyes, Giménez Sánchez, Francisco, Sánchez Forte, Miguel, Rojo, Pablo, Contreras, J. Ruiz, Palacios, Alba, Epalza Ibarrondo, Cristina, Fernández Cooke, Elizabeth, Navarro, Marisa, Álvarez Álvarez, Cristina, José Lozano, María, Carreras, Eduardo, Brió Sanagustín, Sonia, Neth, Olaf, Martínez Padilla, Mª del Carmen, Prieto Tato, Luis Manuel, Guillén, Sara, Fernández Silveira, Laura, Moreno, David, de Groot, R., Tutu van Furth, A.M., van der Flier, M., Boeddha, N.P., Driessen, G.J.A., Emonts, M., Hazelzet, J.A., Kuijpers, T.W., Pajkrt, D., Sanders, E.A.M., van de Beek, D., van der Ende, A., Philipsen, H.L.A., Adeel, A.O.A., Breukels, M.A., Brinkman, D.M.C., de Korte, C.C.M.M., de Vries, E., de Waal, W.J., Dekkers, R., Dings-Lammertink, A., Doedens, R.A., Donker, A.E., Dousma, M., Faber, T.E., Gerrits, G.P.J.M., Gerver, J.A.M., Heidema, J., Homan-van der Veen, J., Jacobs, M.A.M., Jansen, N.J.G., Kawczynski, P., Klucovska, K., Kneyber, M.C.J., Koopman-Keemink, Y., Langenhorst, V.J., Leusink, J., Loza, B.F., Merth, I.T., Miedema, C.J., Neeleman, C., Noordzij, J.G., Obihara, C.C., van Overbeek- van Gils, A.L.T., Poortman, G.H., Potgieter, S.T., Potjewijd, J., Rosias, P.P.R., Sprong, T., ten Tussher, G.W., Thio, B.J., Tramper-Stranders, G.A., van Deuren, M., van der Meer, H., van Kuppevelt, A.J.M., van Wermeskerken, A.M., Verwijs, W.A., Wolfs, T.F.W., Schlapbach, Luregn J., Agyeman, Philipp, Aebi, Christoph, Giannoni, Eric, Stocker, Martin, Posfay-Barbe, Klara M., Heininger, Ulrich, Bernhard-Stirnemann, Sara, Niederer-Loher, Anita, Kahlert, Christian, Hasters, Paul, Relly, Christa, Baer, Walter, Berger, Christoph, Carrol, Enitan D., Paulus, Stéphane, Frederick, Hannah, Jennings, Rebecca, Johnston, Joanne, Kenwright, Rhian, Fink, Colin G, Pinnock, Elli, Emonts, Marieke, Agbeko, Rachel, Anderson, Suzanne, Secka, Fatou, Bojang, Kalifa, Sarr, Isatou, Kebbeh, Ngange, Sey, Gibbi, Saidykhan, Momodou, Cole, Fatoumata, Thomas, Gilleh, Antonio, Martin, Zenz, Werner, Kohlfürst, Daniela S., Binder, Alexander, Schweintzger, Nina A., Sagmeister, Manfred, Baumgart, Hinrich, Baumgartner, Markus, Behrends, Uta, Biebl, Ariane, Birnbacher, Robert, Blanke, Jan-Gerd, Boelke, Carsten, Breuling, Kai, Brunner, Jürgen, Buller, Maria, Dahlem, Peter, Dietrich, Beate, Eber, Ernst, Elias, Johannes, Emhofer, Josef, Etschmaier, Rosa, Farr, Sebastian, Girtler, Ylenia, Grigorow, Irina, Heimann, Konrad, Ihm, Ulrike, Jaros, Zdenek, Kalhoff, Hermann, Kaulfersch, Wilhelm, Kemen, Christoph, Klocker, Nina, Köster, Bernhard, Kohlmaier, Benno, Komini, Eleni, Kramer, Lydia, Neubert, Antje, Ortner, Daniel, Pescollderungg, Lydia, Pfurtscheller, Klaus, Reiter, Karl, Ristic, Goran, Rödl, Siegfried, Sellner, Andrea, Sonnleitner, Astrid, Sperl, Matthias, Stelzl, Wolfgang, Till, Holger, Trobisch, Andreas, Vierzig, Anne, Vogel, Ulrich, Weingarten, Christina, Welke, Stefanie, Wimmer, Andreas, Wintergerst, Uwe, Wüller, Daniel, Zaunschirm, Andrew, Ziuraite, Ieva, Žukovskaja, Veslava, Hibberd, Martin L., Davila, Sonia, Delany, Isabel, Schlapbach, Luregn J, Raman, Sainath, Sharp, Nathalie, Phillips, Natalie, Irwin, Adam, Balch, Ross, Harley, Amanda, Johnson, Kerry, Sever, Zoe, George, Shane, Grimwood, Keith, Snelling, Peter J, Chavan, Arjun, Kitcatt, Eleanor, Lawton, Luke, Hempenstall, Allison, Pilot, Pelista, Gibbons, Kristen S, Le Marsney, Renate, Blumenthal, Antje, Ganesamoorthy, Devika, Pardo, Carolyn, Kling, Jessica, McPherson, Stephen, MacDonald, Anna D, Bialasiewicz, Seweryn, Pham, Trang, and Coin, Lachlan

Abstract

Sepsis is defined as dysregulated host response to infection that leads to life-threatening organ dysfunction. Biomarkers characterising the dysregulated host response in sepsis are lacking. We aimed to develop host gene expression signatures to predict organ dysfunction in children with bacterial or viral infection.

Published
2024
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42. Development of the Birthweight Appropriateness Quotient: A New Measure of Infant's Size

Author

Gibbons, Kristen S., McIntyre, H. David, Mamun, Abdullah, and Chang, Allan M. Z.

Subjects
Body size -- Standards -- Health aspects, Birth weight -- Health aspects, Birth size -- Health aspects, Neonatology -- Standards, Pediatric research, Health care industry
Abstract

Introduction The customised birthweight model can be used to improve detection of babies that may be at risk of adverse outcomes associated with abnormal growth, however it is currently used in conjunction with either an intrauterine growth standard or the individualised birthweight ratio (IBR), both of which have significant methodological flaws. Our aim was to investigate the statistical validity of the IBR and attempt to develop a new measurement to represent the appropriateness of an infant's size at birth that will support clinicians in identifying infants requiring further attention. Methods Routinely collected hospital maternity and neonatal data on singleton, term births from a tertiary Australian hospital were extracted for the time period 1998-2009. The relationships between birthweight, customised birthweight and IBR are investigated using correlation, regression analysis and division of births into groups of 4000 g. A new measure, the Birthweight Appropriateness Quotient (BAQ), is developed. The utility of the BAQ is compared with IBR and birthweight to identify infants with a composite neonatal morbidity outcome. Results Statistical flaws with the IBR due to significant correlation between birthweight and customised birthweight and a heterogenous relationship between these two measurements across the range of birthweight are present. BAQ is uncorrelated with birthweight. Comparison of BAQ and IBR as indicators of adverse neonatal outcome demonstrates that BAQ identifies babies at risk due to their small size and those babies at risk due to inappropriate size. Conclusions for Practice BAQ is a customised measurement of an infant's size free of the statistical flaws experienced by the IBR with the ability to identify at-risk infants., Author(s): Kristen S. Gibbons [sup.1] [sup.5] , H. David McIntyre [sup.1] [sup.2] , Abdullah Mamun [sup.3] , Allan M. Z. Chang [sup.4] Author Affiliations: (1) grid.1003.2, 0000 0000 9320 7537, [...]

Published
2020
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47. REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for a pilot randomised controlled trial (REDUCE-1)

Author

Raman, Sainath, primary, Rahiman, Sarfaraz, additional, Kennedy, Melanie, additional, Mattke, Adrian, additional, Venugopal, Prem, additional, McBride, Craig, additional, Tu, Quyen, additional, Zapf, Florian, additional, Kuhlwein, Eva, additional, Woodgate, Jemma, additional, Singh, Puneet, additional, Schlapbach, Luregn J, additional, and Gibbons, Kristen S, additional

Published
2023
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