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1. Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III

Author

Vestager, Maria Linander; https://orcid.org/0000-0002-3273-0791, Hansen, Mathias Lühr; https://orcid.org/0000-0003-1957-7005, Greisen, Gorm, Pellicer, Adelina, Chathasaigh, Caitriona Ni, Lecart, Chantal, Knoepfli, Claudia, Hagmann, Cornelia; https://orcid.org/0000-0003-2647-9809, Gallo, Dario, Ergenekon, Ebru, Hatzidaki, Eleftheria, Dempsey, Eugene, Papathoma, Evangelina, Dimitrou, Gabriel, Pichler, Gerhard; https://orcid.org/0000-0003-2405-7143, Hahn, Gitte Holst, Naulaers, Gunnar, Fuchs, Hans; https://orcid.org/0000-0003-1303-3699, Ozkan, Hilal, de las Cuevas, Isabel, Serrano-Viñuales, Itziar, Sirc, Jan, de Buyst, Julie, Sarafidis, Kosmos, Arrusa, Luis, Baserga, Mariana, Stocker, Martin; https://orcid.org/0000-0002-1461-333X, Cetinkaya, Merih, Alsina-Casanova, Miguel; https://orcid.org/0000-0002-0139-7279, Fumagalli, Monica, et al, Vestager, Maria Linander; https://orcid.org/0000-0002-3273-0791, Hansen, Mathias Lühr; https://orcid.org/0000-0003-1957-7005, Greisen, Gorm, Pellicer, Adelina, Chathasaigh, Caitriona Ni, Lecart, Chantal, Knoepfli, Claudia, Hagmann, Cornelia; https://orcid.org/0000-0003-2647-9809, Gallo, Dario, Ergenekon, Ebru, Hatzidaki, Eleftheria, Dempsey, Eugene, Papathoma, Evangelina, Dimitrou, Gabriel, Pichler, Gerhard; https://orcid.org/0000-0003-2405-7143, Hahn, Gitte Holst, Naulaers, Gunnar, Fuchs, Hans; https://orcid.org/0000-0003-1303-3699, Ozkan, Hilal, de las Cuevas, Isabel, Serrano-Viñuales, Itziar, Sirc, Jan, de Buyst, Julie, Sarafidis, Kosmos, Arrusa, Luis, Baserga, Mariana, Stocker, Martin; https://orcid.org/0000-0002-1461-333X, Cetinkaya, Merih, Alsina-Casanova, Miguel; https://orcid.org/0000-0002-0139-7279, Fumagalli, Monica, and et al

Abstract

Background The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and ‘opt-out’ are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. Methods All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. Results Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. Conclusions Consent by opt-out was allowed by the protocol in this multinational trial

Published
2024

2. Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III.

Author

Vestager, Maria Linander, Hansen, Mathias Lühr, Greisen, Gorm, Pellicer, Adelina, Chathasaigh, Caitriona Ni, Lecart, Chantal, Knoepfli, Claudia, Hagmann, Cornelia, Gallo, Dario, Ergenekon, Ebru, Hatzidaki, Eleftheria, Dempsey, Eugene, Papathoma, Evangelina, Dimitrou, Gabriel, Pichler, Gerhard, Hahn, Gitte Holst, Naulaers, Gunnar, Fuchs, Hans, Ozkan, Hilal, and de las Cuevas, Isabel

Subjects
PREMATURE infants, PREMATURE labor, INSTITUTIONAL review boards, CLINICAL trials, INFORMED consent (Medical law)
Abstract

Background: The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. Methods: All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. Results: Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. Conclusions: Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Author

Maiwald, Christian A, Annink, Kim V, Ruediger, Mario, Benders, Manon JNL, van Bel, Frank, Allegaert, Karel, Naulaers, Gunnar, Bassler, Dirk, Kleberma-Schrehof, Katrin, Vento, Maximo, Guimaraes, Hercilia, Stiris, Tom, Cattarossi, Luigi, Metsaeranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, Jacobs, Yannique, Franz, Axel R, Poets, Christian F, Benders, Manon, Klebermass-Schrehof, Katrin, Metsaranta, Marjo, van Veldhuizen, Cees KW, Engel, Corinna, von Oldershausen, Gabriele, Bergmann, Iris, Weiss, Monika, Wichera, Caroline JBR, Eichhorn, Andreas, Raubuch, Michael, Schuler, Birgit, Lameris, Bas, van der Vlught-Meijer, Roselinda, Kliniken, Tirol, Griesmaier, Elke, Salzburg, Uniklinikum, Brandner, Johannes, Tackoen, Marie, Reibel, Ruth, Cornette, Luc, Viellevoye, Liege Renaud, Saik, Pille, Kaar, Ruth, Andresson, Pille, Carus, CG, Winkler, Stefan, Hoehn, Thomas, Teig, Norbert, Schroth, Michael, Fusch, Christoph, Thome, Ulrich H, Ehrhardt, Harald, Mauro, Isabella, Baraldi, Eugenio, Carnielli, Virgilio, Paterlini, Monza Giuseppe, Napolitano, Marcello, Faldini, Francesca, Lista, Gian-Luca, Barbarini, Mario, Pagani, Laura, Anna, S, Mastretta, Emmanuele, Vento, Giovanni, Fumagalli, Milano Monica, Binotti, Novara Marco, van Weissenbruch, Mirjam M, van Straaten, Henrica LM, Dudink, Jeroen, Derks, Jan B, de Boer, Inge P, Meijssen, Clemens B, de Haan, Timo R, van Rooij, Linda G, van Hillegersberg, Jacqueline L, van Dongen, Minouche, Dassel, ACM, Dijkman, Koen P, van Houten, Marlies A, van der Schoor, Sophie RD, Nestaas, Eirik, Karpinski, Lukas, Vilan, Ana I, de Pinho, Liliana Flores, Ferraz, Claudia, Pereira, Almerinda, Barroso, Rosalina, da Graca, Mendes, Tome, Teresa, Pinto, Filomena, Martinez Rodilla, Juan, Luz, Maria, Pico, Couce, Camprubi Camprubi, Marta, Hurtado Suazo, Jose Antonio, Valverde, Eva, Fernandez Lorenzo, Jose Ramon, Martinez Orgado, Jose, Boix, Hector, Jimenez Parrilla, Francisco, Blanco, Dorotea, Teresa Moral-Pumarega, Maria, Maletzki, Julia, Knoepfli, Claudia, Hagmann, Cornelia, Kleber, Michael, Schulzke, Sven, Stocker, Martin, Birkenmaier, Andre, and Riedel, Thomas

Subjects
Hypothermia therapy, Perinatal asphyxia, Allopurinol, Hypoxic-ischemic encephalopathy, Neonatal oxygen deficiency, Cerebral palsy, Brain injury, Childbirth outcome
Abstract

BACKGROUND: Perinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia. METHODS: This study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24 months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age ≥ 36 weeks and a birth weight ≥ 2500 g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion. DISCUSSION: This trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia. TRIAL REGISTRATION: NCT03162653, www.ClinicalTrials.gov , May 22, 2017. ispartof: BMC PEDIATRICS vol:19 issue:1 ispartof: location:England status: published

Published
2019

4. Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Author

Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., van Bel, Frank, Allegaert, Karel, Naulaers, Gunnar, Bassler, Dirk, Klebermaß-Schrehof, Katrin, Vento, Maximo, Guimarães, Hercilia, Stiris, Tom, Cattarossi, Luigi, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, Jacobs, Yannique, Franz, Axel R., Poets, Christian F., van Veldhuizen, Cees, Engel, Corinna, von Oldershausen, Gabriele, Bergmann, Iris, Weiss, Monika, Wichera, Caroline J. B. R., Eichhorn, Andreas, Raubuch, Michael, Schuler, Birgit, van Veldhuizen, Cees K. W., Laméris, Bas, van der Vlught-Meijer, Roselinda, Griesmaier, Elke, Brandner, Johannes, Tackoen, Marie, Reibel, Ruth, Lecart, Chantal, Cornette, Luc, Malfilatre, Genevieve, Viellevoye, Renaud, Ilmoja, Mari-Liis, Saik, Pille, Käär, Ruth, Andresson, Pille, Schloesser, Rolf, Ott, Torsten, Winkler, Stefan, Hoehn, Thomas, Teig, Norbert, Schroth, Michael, Thome, Ulrich H., Ehrhardt, Harald, Mauro, Isabella, Baraldi, Eugenio, Carnielli, Virgilio, Paterlini, Giuseppe, Napolitano, Marcello, Faldini, Paola Francesca, Lista, Gianluca, Visintin, Gianluca, Barbarini, Mario, Pagani, Laura, Mastretta, Emmanuele, Vento, Giovanni, Fumagalli, Monica, Binotti, Marco, van Weissenbruch, Mirjam M., van Straaten, Henrica L. M., Dudink, Jeroen, Derks, Jan B., de Boer, Inge P., Meijssen, Clemens B., de Haan, Timo R., van Rooij, Linda G., van Hillegersberg, Jacqueline L., van Dongen, Minouche, Bruinenberg, Jos, Dijkman, Koen P., van Houten, Marlies A., van der Schoor, Sophie R. D., Salvesen, Bodil, Schneider, Moritz, Nestaas, Eirik, Nakstad, Britt, Karpinski, Lukas, Gulczynska, Ewa, Królak-Olejnik, Barbara, Bokiniec, Renata, Vilan, Ana I., de Pinho, Liliana Flores, Ferraz, Claudia, Pereira, Almerinda, Barroso, Rosalina, da Graça, André Mendes, Tomé, Teresa, Pinto, Filomena, Rodilla, Juan Martínez, Lubián, Simón, Camprubí, Marta Campubri, Suazo, José Antonio Hurtado, Valverde, Eva, Lorenzo, José Ramón Fernández, Orgado, José Martinez, Boix, H. ctor, Parrilla, Francisco Jimenez, Moral-Pumarega, Maria Teresa, Maletzki, Julia, Knoepfli, Claudia, Hagmann, Cornelia, Schulzke, Sven, Stocker, Martin, Birkenmaier, André, Riedel, Thomas, Ehni, Hans-J. rg, Janvier, Annie, Marckmann, Georg, European Commission, German Research Foundation, Amsterdam Reproduction & Development (AR&D), Pediatric surgery, ACS - Diabetes & metabolism, AGEM - Endocrinology, metabolism and nutrition, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, Anatomy and neurosciences, HUS Children and Adolescents, HUS Medical Imaging Center, Children's Hospital, Doctoral Programme in Clinical Research, Department of Neurosciences, Clinicum, Doctoral Programme Brain & Mind, Kliinisen neurofysiologian yksikkö, Neonatology, and AGEM - Digestive immunity

Subjects
double blind procedure, drug safety, induced hypothermia, Antimetabolites, Neonatal oxygen deficiency, groups by age, mental disease, Allopurinol, Brain injury, Cerebral palsy, Childbirth outcome, Hypothermia therapy, Hypoxic-ischemic encephalopathy, Perinatal asphyxia, Study Protocol, heart function, newborn, phase 3 clinical trial (topic), 3123 Gynaecology and paediatrics, Hypothermia, Induced, Multicenter Studies as Topic, nuclear magnetic resonance imaging, randomized controlled trial (topic), multimodality cancer therapy, Allopurinol, Neonatal oxygen deficiency, Hypothermia therapy, Childbirth outcome, Hypoxic-ischemic encephalopathy, Perinatal asphyxia, Brain injury, Cerebral palsy, Randomized Controlled Trials as Topic, drug effect, Combined Modality Therapy, health care quality, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Hypoxia-Ischemia, Brain, multicenter study (topic), disease severity, hypothermia, echoencephalography, hypoxic ischemic encephalopathy, Gestational Age, Article, Double-Blind Method, protein S100B, Humans, controlled study, drug screening, human, newborn mortality, procedures, antimetabolite, phase 3 clinical trial, Infant, Newborn, birth weight, Infant, electroencephalogram, major clinical study, mortality, drug efficacy, Clinical Trials, Phase III as Topic, Neurodevelopmental Disorders, randomized controlled trial, incidence, treatment outcome
Abstract

Consortia for the ALBINO Study Group: Axel R. Franz, Mario Rüdiger, Christian F. Poets, Manon Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Hercilia Guimarães, Tom Stiris, Luigi Cattarossi, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Cees van Veldhuizen, Corinna Engel, Christian A. Maiwald, Gabriele von Oldershausen, Iris Bergmann, Monika Weiss, Caroline J. B. R. Wichera, Andreas Eichhorn, Michael Raubuch, Birgit Schuler, Cees K. W. van Veldhuizen, Bas Laméris, Yannique Jacobs, Roselinda van der Vlught-Meijer, Elke Griesmaier, Johannes Brandner, Marie Tackoen, Ruth Reibel, Chantal Lecart, Luc Cornette, Genevieve Malfilatre, Renaud Viellevoye, Tuuli Metsvaht, Mari-Liis Ilmoja, Pille Saik, Ruth Käär, Pille Andresson, Marjo Metsaranta, Axel R. Franz, Rolf Schloesser, Torsten Ott, Stefan Winkler, Thomas Hoehn, Norbert Teig, Michael Schroth, Ulrich H. Thome, Harald Ehrhardt, Luigi Cattarossi, Isabella Mauro, Eugenio Baraldi, Virgilio Carnielli, Giuseppe Paterlini, Marcello Napolitano, Paola Francesca Faldini, Gianluca Lista, Gianluca Visintin, Mario Barbarini, Laura Pagani, Emmanuele Mastretta, Giovanni Vento, Monica Fumagalli, Marco Binotti, Mirjam M. van Weissenbruch, Henrica L. M. van Straaten, Manon J. N. L. Benders, Kim V. Annink, Frank van Bel, Jeroen Dudink, Jan B. Derks, Inge P. de Boer, Clemens B. Meijssen, Timo R. de Haan, Linda G. van Rooij, Jacqueline L. van Hillegersberg, Minouche van Dongen, Jos Bruinenberg, Koen P. Dijkman, Marlies A. van Houten, Sophie R. D. van der Schoor, Tom Stiris, Bodil Salvesen, Moritz Schneider, Eirik Nestaas, Britt Nakstad, Jan Mazela, Lukas Karpinski, Ewa Gulczynska, Barbara Królak-Olejnik, Renata Bokiniec, Ana I. Vilan, Liliana Flores de Pinho, Claudia Ferraz, Almerinda Pereira, Rosalina Barroso, André Mendes da Graça, Teresa Tomé, Filomena Pinto, Maximo Vento, Juan Martínez Rodilla, Simón Lubián, Marta Campubri Camprubí, José Antonio Hurtado Suazo, Eva Valverde, José Ramón Fernández Lorenzo, José Martinez Orgado, Héctor Boix, Francisco Jimenez Parrilla, Maria Teresa Moral-Pumarega, Julia Maletzki, Claudia Knoepfli, Cornelia Hagmann, Sven Schulzke, Martin Stocker, André Birkenmaier, Thomas Riedel, Hans-Jörg Ehni, Annie Janvier & Georg Marckmann., [Background]: Perinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia., [Methods]: This study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24 months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age ≥ 36 weeks and a birth weight ≥ 2500 g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion., [Discussion]: This trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia., [Trial registration]: NCT03162653, www.ClinicalTrials.gov, May 22, 2017., This study is funded under the Horizon 2020 Framework Program of the European Union, call H2020-PHC-2015-two-stage, grant 667224. Publication of this manuscript was supported by Deutsche Forschungsgemeinschaft and the Open Access Publishing Fund of the University of Tuebingen.

Published
2019

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