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15 results on '"Klebermass‐Schrehof, Katrin"'

1. Global cross-sectional survey on neonatal pharmacologic sedation and analgesia practices and pain assessment tools: impact of the sociodemographic index (SDI)

Author

Arribas, Cristina, Cavallaro, Giacomo, Gonzalez, Juan-Luis, Lagares, Carolina, Raffaeli, Genny, Smits, Anne, Simons, Sinno H. P., Villamor, Eduardo, Allegaert, Karel, Garrido, Felipe, Amponsah, Abigail Kusi, van den Hoogen, Agnes, Ullsten, Alexandra, Amigoni, Angela, Axelin, Anna, Palomaa, Annakaija, Bhatt, Aomesh, Rønnestad, Arild, Duse, Beatrice Olsson, Vederhus, Bente Johanne, Tandberg, Bente Silnes, Joosten, Bert, Hartley, Caroline, Kotidis, Charalampos, Roehr, Charles Christoph, van Ganzewinkel, Christ-Jan, Machado, Daniela Sofia Horta, Roofthooft, Daniëlla, Norman, Elisabeth, Olsson, Emma, Dempsey, Eugene, Mörelius, Evalotte, Le Marechal, Flore, Sperotto, Francesca, van den Bosch, Gerbrich, Kristjánsdóttir, Guðrún, Ahl, Hanna, Stensvold, Hans Jørgen, Haslund-Thomsen, Helle, Weiss, Janne, Andresen, Jannicke Hanne, Roue, Jean-Michel, Wielenga, Joke, ten Barge, Judith, Klebermass-Schrehof, Katrin, Kristoffersen, Laila, Moschino, Laura, Arribas, Cristina, Cavallaro, Giacomo, Gonzalez, Juan-Luis, Lagares, Carolina, Raffaeli, Genny, Smits, Anne, Simons, Sinno H. P., Villamor, Eduardo, Allegaert, Karel, Garrido, Felipe, Amponsah, Abigail Kusi, van den Hoogen, Agnes, Ullsten, Alexandra, Amigoni, Angela, Axelin, Anna, Palomaa, Annakaija, Bhatt, Aomesh, Rønnestad, Arild, Duse, Beatrice Olsson, Vederhus, Bente Johanne, Tandberg, Bente Silnes, Joosten, Bert, Hartley, Caroline, Kotidis, Charalampos, Roehr, Charles Christoph, van Ganzewinkel, Christ-Jan, Machado, Daniela Sofia Horta, Roofthooft, Daniëlla, Norman, Elisabeth, Olsson, Emma, Dempsey, Eugene, Mörelius, Evalotte, Le Marechal, Flore, Sperotto, Francesca, van den Bosch, Gerbrich, Kristjánsdóttir, Guðrún, Ahl, Hanna, Stensvold, Hans Jørgen, Haslund-Thomsen, Helle, Weiss, Janne, Andresen, Jannicke Hanne, Roue, Jean-Michel, Wielenga, Joke, ten Barge, Judith, Klebermass-Schrehof, Katrin, Kristoffersen, Laila, and Moschino, Laura

Published
2024
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2. Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Author

Engel, Corinna; https://orcid.org/0000-0002-8565-6986, Rüdiger, Mario, Benders, Manon J N L; https://orcid.org/0000-0001-5491-9168, van Bel, Frank, Allegaert, Karel; https://orcid.org/0000-0001-9921-5105, Naulaers, Gunnar, Bassler, Dirk, Klebermaß-Schrehof, Katrin, Vento, Maximo; https://orcid.org/0000-0003-0061-4742, Vilan, Ana, Falck, Mari, Mauro, Isabella, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, van der Vlught, Roselinda, Franz, Axel R; https://orcid.org/0000-0001-5066-0857, ALBINO Study Group, Engel, Corinna; https://orcid.org/0000-0002-8565-6986, Rüdiger, Mario, Benders, Manon J N L; https://orcid.org/0000-0001-5491-9168, van Bel, Frank, Allegaert, Karel; https://orcid.org/0000-0001-9921-5105, Naulaers, Gunnar, Bassler, Dirk, Klebermaß-Schrehof, Katrin, Vento, Maximo; https://orcid.org/0000-0003-0061-4742, Vilan, Ana, Falck, Mari, Mauro, Isabella, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, van der Vlught, Roselinda, Franz, Axel R; https://orcid.org/0000-0001-5066-0857, and ALBINO Study Group

Abstract

BACKGROUND: Despite therapeutic hypothermia (TH) and neonatal intensive care, 45-50% of children affected by moderate-to-severe neonatal hypoxic-ischemic encephalopathy (HIE) die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective therapies are sought, besides TH, to further improve the outcome of affected infants. Allopurinol - a xanthine oxidase inhibitor - reduced the production of oxygen radicals and subsequent brain damage in pre-clinical and preliminary human studies of cerebral ischemia and reperfusion, if administered before or early after the insult. This ALBINO trial aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to (near-)term infants with early signs of HIE. METHODS/DESIGN: The ALBINO trial is an investigator-initiated, randomized, placebo-controlled, double-blinded, multi-national parallel group comparison for superiority investigating the effect of allopurinol in (near-)term infants with neonatal HIE. Primary endpoint is long-term outcome determined as survival with neurodevelopmental impairment versus death versus non-impaired survival at 2 years. RESULTS: The primary analysis with three mutually exclusive responses (healthy, death, composite outcome for impairment) will be on the intention-to-treat (ITT) population by a generalized logits model according to Bishop, Fienberg, Holland (Bishop YF, Discrete Multivariate Analysis: Therory and Practice, 1975) and ."will be stratified for the two treatment groups. DISCUSSION: The statistical analysis for the ALBINO study was defined in detail in the study protocol and implemented in this statistical analysis plan published prior to any data analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines.

Published
2024

3. European Consensus Guidelines on the Management of Respiratory Distress Syndrome:2022 Update

Author

Sweet, David G., Carnielli, Virgilio P., Greisen, Gorm, Hallman, Mikko, Klebermass-Schrehof, Katrin, Ozek, Eren, Te Pas, Arjan, Plavka, Richard, Roehr, Charles C., Saugstad, Ola D., Simeoni, Umberto, Speer, Christian P., Vento, Maximo, Visser, Gerry H. A., Halliday, Henry L., Sweet, David G., Carnielli, Virgilio P., Greisen, Gorm, Hallman, Mikko, Klebermass-Schrehof, Katrin, Ozek, Eren, Te Pas, Arjan, Plavka, Richard, Roehr, Charles C., Saugstad, Ola D., Simeoni, Umberto, Speer, Christian P., Vento, Maximo, Visser, Gerry H. A., and Halliday, Henry L.

Abstract

Respiratory distress syndrome (RDS) care pathways evolve slowly as new evidence emerges. We report the sixth version of "European Guidelines for the Management of RDS"by a panel of experienced European neonatologists and an expert perinatal obstetrician based on available literature up to end of 2022. Optimising outcome for babies with RDS includes prediction of risk of preterm delivery, appropriate maternal transfer to a perinatal centre, and appropriate and timely use of antenatal steroids. Evidence-based lung-protective management includes initiation of non-invasive respiratory support from birth, judicious use of oxygen, early surfactant administration, caffeine therapy, and avoidance of intubation and mechanical ventilation where possible. Methods of ongoing non-invasive respiratory support have been further refined and may help reduce chronic lung disease. As technology for delivering mechanical ventilation improves, the risk of causing lung injury should decrease, although minimising time spent on mechanical ventilation by targeted use of postnatal corticosteroids remains essential. The general care of infants with RDS is also reviewed, including emphasis on appropriate cardiovascular support and judicious use of antibiotics as being important determinants of best outcome. We would like to dedicate this guideline to the memory of Professor Henry Halliday who died on November 12, 2022.These updated guidelines contain evidence from recent Cochrane reviews and medical literature since 2019. Strength of evidence supporting recommendations has been evaluated using the GRADE system. There are changes to some of the previous recommendations as well as some changes to the strength of evidence supporting recommendations that have not changed. This guideline has been endorsed by the European Society for Paediatric Research (ESPR) and the Union of European Neonatal and Perinatal Societies (UENPS).

Published
2023

4. European Consensus Guidelines on the Management of Respiratory Distress Syndrome:2022 Update

Author

Sweet, David G., Carnielli, Virgilio P., Greisen, Gorm, Hallman, Mikko, Klebermass-Schrehof, Katrin, Ozek, Eren, Te Pas, Arjan, Plavka, Richard, Roehr, Charles C., Saugstad, Ola D., Simeoni, Umberto, Speer, Christian P., Vento, Maximo, Visser, Gerry H. A., Halliday, Henry L., Sweet, David G., Carnielli, Virgilio P., Greisen, Gorm, Hallman, Mikko, Klebermass-Schrehof, Katrin, Ozek, Eren, Te Pas, Arjan, Plavka, Richard, Roehr, Charles C., Saugstad, Ola D., Simeoni, Umberto, Speer, Christian P., Vento, Maximo, Visser, Gerry H. A., and Halliday, Henry L.

Abstract

Respiratory distress syndrome (RDS) care pathways evolve slowly as new evidence emerges. We report the sixth version of "European Guidelines for the Management of RDS"by a panel of experienced European neonatologists and an expert perinatal obstetrician based on available literature up to end of 2022. Optimising outcome for babies with RDS includes prediction of risk of preterm delivery, appropriate maternal transfer to a perinatal centre, and appropriate and timely use of antenatal steroids. Evidence-based lung-protective management includes initiation of non-invasive respiratory support from birth, judicious use of oxygen, early surfactant administration, caffeine therapy, and avoidance of intubation and mechanical ventilation where possible. Methods of ongoing non-invasive respiratory support have been further refined and may help reduce chronic lung disease. As technology for delivering mechanical ventilation improves, the risk of causing lung injury should decrease, although minimising time spent on mechanical ventilation by targeted use of postnatal corticosteroids remains essential. The general care of infants with RDS is also reviewed, including emphasis on appropriate cardiovascular support and judicious use of antibiotics as being important determinants of best outcome. We would like to dedicate this guideline to the memory of Professor Henry Halliday who died on November 12, 2022.These updated guidelines contain evidence from recent Cochrane reviews and medical literature since 2019. Strength of evidence supporting recommendations has been evaluated using the GRADE system. There are changes to some of the previous recommendations as well as some changes to the strength of evidence supporting recommendations that have not changed. This guideline has been endorsed by the European Society for Paediatric Research (ESPR) and the Union of European Neonatal and Perinatal Societies (UENPS).

Published
2023

5. Proceedings of the 13th International Newborn Brain Conference: Neuro-imaging studies

Author

MS Neonatologie, Beeldverwerking ISI, Brain, Cancer, Trialbureau Beeld, Abramsky, Ramy, Acosta, Rebeka, Acosta Izquierdo, Laura, Albeshri, Bushra, Almouqdad, Mountasser, Asfour, Yasmeen, Asfour, Suzan, Austin, Topun, Bach, Ashley, Barkovich, Jim, Beare, Richard, Ben Fadel, Nadya, Benner, Eric, Berger, Angelika, Blanco, Borja, Boomsma, Martijn, Bora, Samudragupta, Boswinkel, Vivian, Chao, Agnes, Chin, Theresa, Collins-Jones, Liam, Cooper, Robert, Dagur, Gautam, Davila, Jorge, de Vries, Linda, Shesrao, Laxmikant, Dovjak, Gregor, Dubois, Laura, Edwards, Andrea, El-Dib, Mohamed, Elshibiny, Hoda, Eshel, Dafna, Eshel, Ron, Ferriero, Donna, Gano, Dawn, Girvan, Olivia, Glass, Hannah, Goeral, Katharina, Golan, Agneta, Goldberg, Ronald N, Gregory, Simon, Gurvitz, Michelle, Inder, Terrie, Jain, Vaibhav, Jamjoom, Dima, Kadom, Nadja, Kasprian, Gregor, Khalil, Thanaa, Klebermass-Schrehof, Katrin, Kleinmahon, Jake, Krüse-Ruijter, Martine, Lambing, Hannah, Lee, Sarah, Leemans, Alexander, Leijser, Lara, Lemyre, Brigitte, Li, Yi, Maltais-Bilodeau, Camille, Marks, Kyla, Matak, Pavle, McCulloch, Charles, Milla, Sarah, Miller, Elka, Mishra, Aradhana, Mitsakakis, Nicholas, Mohammad, Khorshid, Tollenaer, Susanne Mulder-de, Munster, Chelsea, Nijboer-Oosterveld, Jacqueline, Nijholt, Ingrid, Novoa, Rosa, Ortinau, Cynthia, Pegram, Kelly, Porter, Emma, Prayer, Daniela, Reddy, Deepti, Redpath, Stephanie, Rogers, Elizabeth, Schmidbauer, Victor, Scott, James, Sewell, Elizabeth, Shany, Eilon, Shelef, Ilan, Singh, Elizabeth, Slump, Cornelis, Steele, Tina, Szakmar, Eniko, Tax, Chantal, Thiim, Kirsten, Thompson, J Will, Uchitel, Julie, van Osch, Jochen, van Wezel-Meijler, Gerda, Verschuur, Anouk, Wu-Smit, Mei-Nga, Yang, Edward, Younge, Noelle, Zein, Hussein, MS Neonatologie, Beeldverwerking ISI, Brain, Cancer, Trialbureau Beeld, Abramsky, Ramy, Acosta, Rebeka, Acosta Izquierdo, Laura, Albeshri, Bushra, Almouqdad, Mountasser, Asfour, Yasmeen, Asfour, Suzan, Austin, Topun, Bach, Ashley, Barkovich, Jim, Beare, Richard, Ben Fadel, Nadya, Benner, Eric, Berger, Angelika, Blanco, Borja, Boomsma, Martijn, Bora, Samudragupta, Boswinkel, Vivian, Chao, Agnes, Chin, Theresa, Collins-Jones, Liam, Cooper, Robert, Dagur, Gautam, Davila, Jorge, de Vries, Linda, Shesrao, Laxmikant, Dovjak, Gregor, Dubois, Laura, Edwards, Andrea, El-Dib, Mohamed, Elshibiny, Hoda, Eshel, Dafna, Eshel, Ron, Ferriero, Donna, Gano, Dawn, Girvan, Olivia, Glass, Hannah, Goeral, Katharina, Golan, Agneta, Goldberg, Ronald N, Gregory, Simon, Gurvitz, Michelle, Inder, Terrie, Jain, Vaibhav, Jamjoom, Dima, Kadom, Nadja, Kasprian, Gregor, Khalil, Thanaa, Klebermass-Schrehof, Katrin, Kleinmahon, Jake, Krüse-Ruijter, Martine, Lambing, Hannah, Lee, Sarah, Leemans, Alexander, Leijser, Lara, Lemyre, Brigitte, Li, Yi, Maltais-Bilodeau, Camille, Marks, Kyla, Matak, Pavle, McCulloch, Charles, Milla, Sarah, Miller, Elka, Mishra, Aradhana, Mitsakakis, Nicholas, Mohammad, Khorshid, Tollenaer, Susanne Mulder-de, Munster, Chelsea, Nijboer-Oosterveld, Jacqueline, Nijholt, Ingrid, Novoa, Rosa, Ortinau, Cynthia, Pegram, Kelly, Porter, Emma, Prayer, Daniela, Reddy, Deepti, Redpath, Stephanie, Rogers, Elizabeth, Schmidbauer, Victor, Scott, James, Sewell, Elizabeth, Shany, Eilon, Shelef, Ilan, Singh, Elizabeth, Slump, Cornelis, Steele, Tina, Szakmar, Eniko, Tax, Chantal, Thiim, Kirsten, Thompson, J Will, Uchitel, Julie, van Osch, Jochen, van Wezel-Meijler, Gerda, Verschuur, Anouk, Wu-Smit, Mei-Nga, Yang, Edward, Younge, Noelle, and Zein, Hussein

Published
2022

6. Safety and Short-term Outcomes of High-Dose Erythropoietin in Preterm Infants With Intraventricular Hemorrhage: The EpoRepair Randomized Clinical Trial

Author

Wellmann, Sven, Hagmann, Cornelia F; https://orcid.org/0000-0003-2647-9809, von Felten, Stefanie; https://orcid.org/0000-0002-5264-6394, Held, Leonard, Klebermass-Schrehof, Katrin, Truttmann, Anita C, Knöpfli, Claudia, Fauchere, Jean-Claude; https://orcid.org/0000-0001-8158-7410, Bührer, Christoph, Bucher, Hans Ulrich; https://orcid.org/0000-0003-4458-1161, Rüegger, Christoph M; https://orcid.org/0000-0003-1496-2625, Wellmann, Sven, Hagmann, Cornelia F; https://orcid.org/0000-0003-2647-9809, von Felten, Stefanie; https://orcid.org/0000-0002-5264-6394, Held, Leonard, Klebermass-Schrehof, Katrin, Truttmann, Anita C, Knöpfli, Claudia, Fauchere, Jean-Claude; https://orcid.org/0000-0001-8158-7410, Bührer, Christoph, Bucher, Hans Ulrich; https://orcid.org/0000-0003-4458-1161, and Rüegger, Christoph M; https://orcid.org/0000-0003-1496-2625

Abstract

IMPORTANCE Intraventricular hemorrhage (IVH) is a major cause of neonatal morbidity and mortality in preterm infants without a specific medical treatment to date. OBJECTIVE To assess the safety and short-term outcomes of high-dose erythropoietin in preterm infants with IVH. DESIGN, SETTING, AND PARTICIPANTS Between April 1, 2014, and August 3, 2018, a randomized double-blind clinical trial enrolled 121 preterm infants (gestational age <32 weeks or birth weight <1500 g) aged 8 or less days with moderate to severe IVH identified by cerebral ultrasonography from 8 Swiss and Austrian tertiary neonatal units. Statistical analyses were performed between October 1, 2019, and September 12, 2022. INTERVENTIONS Infants received intravenous high-dose erythropoietin (2000 units/kg body weight) or placebo at 4 time points between weeks 1 and 4 of life. MAIN OUTCOMES AND MEASURES Secondary outcomes included (1) mortality and morbidity rates and (2) brain magnetic resonance imaging findings at term-equivalent age (TEA). The primary outcome was the composite intelligence quotient at 5 years of age (not available before 2023). RESULTS Sixty infants (48% male [n = 29]) were randomly assigned to receive erythropoietin, and 61 infants (61% male [n = 37]) were randomly assigned to receive placebo. The median birth weight was 832 g (IQR, 687-990 g) in the erythropoietin group and 870 g (IQR, 680-1110 g) in the placebo group. Median gestation was 26.1 weeks (IQR, 24.8-27.3 weeks) in the erythropoietin group and 27.0 weeks (24.9-28.1 weeks) in the placebo group. The 2 groups had similar baseline characteristics and morbidities. Up to TEA, 10 newborns died (16.7%) in the erythropoietin group, and 5 newborns (8.2%) died in the placebo group (adjusted odds ratio, 2.24 [95% CI, 0.74-7.66]; P = .15). Infants receiving erythropoietin had higher mean hematocrit levels. Conventional magnetic resonance imaging at TEA for 100 infants showed no significant differences in global or regional brain inju

Published
2022

7. Reliability and accuracy of EEG interpretation for estimating age in preterm infants

Author

MS Neonatologie, Brain, Stevenson, Nathan J, Tataranno, Maria-Luisa, Kaminska, Anna, Pavlidis, Elena, Clancy, Robert R, Griesmaier, Elke, Roberts, James A, Klebermass-Schrehof, Katrin, Vanhatalo, Sampsa, MS Neonatologie, Brain, Stevenson, Nathan J, Tataranno, Maria-Luisa, Kaminska, Anna, Pavlidis, Elena, Clancy, Robert R, Griesmaier, Elke, Roberts, James A, Klebermass-Schrehof, Katrin, and Vanhatalo, Sampsa

Published
2020

8. Automated cot-side tracking of functional brain age in preterm infants

Author

Child Health, MS Neonatologie, Brain, Stevenson, Nathan J, Oberdorfer, Lisa, Tataranno, Maria-Luisa, Breakspear, Michael, Colditz, Paul B, de Vries, Linda S, Benders, Manon J N L, Klebermass-Schrehof, Katrin, Vanhatalo, Sampsa, Roberts, James A, Child Health, MS Neonatologie, Brain, Stevenson, Nathan J, Oberdorfer, Lisa, Tataranno, Maria-Luisa, Breakspear, Michael, Colditz, Paul B, de Vries, Linda S, Benders, Manon J N L, Klebermass-Schrehof, Katrin, Vanhatalo, Sampsa, and Roberts, James A

Published
2020

9. 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., Bel, Frank van, 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., ALBINO Study Group, Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., Bel, Frank van, 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., and ALBINO Study Group

Published
2019

10. 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., Bel, Frank van, 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., ALBINO Study Group, Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., Bel, Frank van, 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., and ALBINO Study Group

Published
2019

11. 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., Bel, Frank van, 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., ALBINO Study Group, Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., Bel, Frank van, 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., and ALBINO Study Group

Published
2019

12. 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; https://orcid.org/0000-0001-5066-0857, ALBINO Study Group, 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; https://orcid.org/0000-0001-5066-0857, and ALBINO Study Group

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

Published
2019

13. 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, Carnielli, Virgilio, Dudink, Jeroen, Stocker, Martin, 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, Carnielli, Virgilio, Dudink, Jeroen, and Stocker, Martin

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 provid

Published
2019

14. 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., Bel, Frank van, 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., ALBINO Study Group, Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., Bel, Frank van, 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., and ALBINO Study Group

Published
2019

15. 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

European Commission, German Research Foundation, Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., Bel, Frank van, Allegaer, Karel, Naulaer, Gunnar, Bassler, Dirk, Klebermaß-Schrehof, Katrin, Vento, Máximo, Guimarães, Hercilia, Stiris, Tom, Cattarossi, Luigi, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, Jacobs, Yannique, Franz, Axel R., European Commission, German Research Foundation, Maiwald, Christian A., Annink, Kim V., Rüdiger, Mario, Benders, Manon J. N. L., Bel, Frank van, Allegaer, Karel, Naulaer, Gunnar, Bassler, Dirk, Klebermaß-Schrehof, Katrin, Vento, Máximo, Guimarães, Hercilia, Stiris, Tom, Cattarossi, Luigi, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, Jacobs, Yannique, and Franz, Axel R.

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.

Published
2019

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