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1. 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

Benders, MJNL, Klebermass-Schrehof, K, Metsaranta, M, Rudiger, M, Poets, CF, Benders, M, Allegaert, K, Naulaers, G, Guimaraes, H, Stiris, T, Vanhatalo, S, Metsvaht, T, Engel, C, Maiwald, CA, von Oldershausen, G, Bergmann, I, Weiss, M, Wichera, CJBR, Eichhorn, A, Raubuch, M, Schuler, B, van Veldhuizen, CKW, Lameris, B, Jacobs, Y, van der Vlught-Meijer, R, Kliniken, T, Griesmaier, E, Salzburg, U, Brandner, J, Tackoen, M, Reibel, R, Cornette, L, Viellevoye, LR, Saik, P, Kaar, R, Andresson, P, Franz, AR, Carus, CG, Winkler, S, Hoehn, T, Teig, N, Schroth, M, Fusch, C, Thome, UH, Ehrhardt, H, Cattarossi, L, Mauro, I, Baraldi, E, Carnielli, V, Paterlini, MG, Napolitano, M, Faldini, F, Lista, GL, Barbarini, M, Pagani, L, Anna, S, Mastretta, E, Vento, G, Fumagalli, MM, Binotti, NM, van Weissenbruch, MM, van Straaten, HLM, Annink, KV, van Bel, F, Dudink, J, Derks, JB, de Boer, IP, Meijssen, CB, de Haan, TR, van Rooij, LG, van Hillegersberg, JL, van Dongen, M, Dassel, ACM, Dijkman, KP, van Houten, MA, van der Schoor, SRD, Nestaas, E, Mazela, J, Karpinski, L, Vilan, AI, de Pinho, LF, Ferraz, C, Pereira, A, Barroso, R, da Graca, M, Tome, T, Pinto, F, Vento, M, Rodilla, JM, Luz, M, Pico, C, Camprubi, MC, Suazo, JAH, Valverde, E, Lorenzo, JRF, Orgado, JM, Boix, H, Parrilla, FJ, Blanco, D, Moral-Pumarega, MT, Bassler, D, Maletzki, J, Knoepfli, C, Hagmann, C, Kleber, M, Schulzke, S, Stocker, M, Birkenmaier, A, Riedel, T, and ALBINO Study Grp

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

BackgroundPerinatal 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.MethodsThis 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 24months 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 age36weeks and a birth weight2500g, 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.DiscussionThis 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 registrationNCT03162653, www.ClinicalTrials.gov, May 22, 2017.

Published
2019

2. 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, C. A., Annink, K. V., Rudiger, M., Benders, M. J. N. L., Van Bel, F., Allegaert, K., Naulaers, G., Bassler, D., Klebermass-Schrehof, K., Vento, M., Guimaraes, H., Stiris, T., Cattarossi, L., Metsaranta, M., Vanhatalo, S., Mazela, J., Metsvaht, T., Jacobs, Y., Franz, A. R., Poets, C. F., Van Veldhuizen, C., Engel, C., Von Oldershausen, G., Bergmann, I., Weiss, M., Wichera, C. J. B. R., Eichhorn, A., Raubuch, M., Schuler, B., Van Veldhuizen, C. K. W., Lameris, B., Van Der Vlught-Meijer, R., Griesmaier, E., Brandner, J., Tackoen, M., Reibel, R., Lecart, C., Cornette, L., Malfilatre, G., Viellevoye, R., Ilmoja, M. -L., Saik, P., Kaar, R., Andresson, P., Schloesser, R., Ott, T., Winkler, S., Hoehn, T., Teig, N., Schroth, M., Thome, U. H., Ehrhardt, H., Mauro, I., Baraldi, E., Carnielli, V., Paterlini, G., Napolitano, M., Faldini, P. F., Lista, G., Visintin, G., Barbarini, M., Pagani, L., Mastretta, E., Vento, Giovanni, Fumagalli, M., Binotti, M., Van Weissenbruch, M. M., Van Straaten, H. L. M., Dudink, J., Derks, J. B., De Boer, I. P., Meijssen, C. B., De Haan, T. R., Van Rooij, L. G., Van Hillegersberg, J. L., Van Dongen, M., Bruinenberg, J., Dijkman, K. P., Van Houten, M. A., Van Der Schoor, S. R. D., Salvesen, B., Schneider, M., Nestaas, E., Nakstad, B., Karpinski, L., Gulczynska, E., Krolak-Olejnik, B., Bokiniec, R., Vilan, A. I., De Pinho, L. F., Ferraz, C., Pereira, A., Barroso, R., Da Graca, A. M., Tome, T., Pinto, F., Rodilla, J. M., Lubian, S., Camprubi, M. C., Suazo, J. A. H., Valverde, E., Lorenzo, J. R. F., Orgado, J. M., Boix, H., Parrilla, F. J., Moral-Pumarega, M. T., Maletzki, J., Knoepfli, C., Hagmann, C., Schulzke, S., Stocker, M., Birkenmaier, A., Riedel, T., Ehni, H. -J., Janvier, A., Marckmann, G., Vento G. (ORCID:0000-0002-8132-5127), Maiwald, C. A., Annink, K. V., Rudiger, M., Benders, M. J. N. L., Van Bel, F., Allegaert, K., Naulaers, G., Bassler, D., Klebermass-Schrehof, K., Vento, M., Guimaraes, H., Stiris, T., Cattarossi, L., Metsaranta, M., Vanhatalo, S., Mazela, J., Metsvaht, T., Jacobs, Y., Franz, A. R., Poets, C. F., Van Veldhuizen, C., Engel, C., Von Oldershausen, G., Bergmann, I., Weiss, M., Wichera, C. J. B. R., Eichhorn, A., Raubuch, M., Schuler, B., Van Veldhuizen, C. K. W., Lameris, B., Van Der Vlught-Meijer, R., Griesmaier, E., Brandner, J., Tackoen, M., Reibel, R., Lecart, C., Cornette, L., Malfilatre, G., Viellevoye, R., Ilmoja, M. -L., Saik, P., Kaar, R., Andresson, P., Schloesser, R., Ott, T., Winkler, S., Hoehn, T., Teig, N., Schroth, M., Thome, U. H., Ehrhardt, H., Mauro, I., Baraldi, E., Carnielli, V., Paterlini, G., Napolitano, M., Faldini, P. F., Lista, G., Visintin, G., Barbarini, M., Pagani, L., Mastretta, E., Vento, Giovanni, Fumagalli, M., Binotti, M., Van Weissenbruch, M. M., Van Straaten, H. L. M., Dudink, J., Derks, J. B., De Boer, I. P., Meijssen, C. B., De Haan, T. R., Van Rooij, L. G., Van Hillegersberg, J. L., Van Dongen, M., Bruinenberg, J., Dijkman, K. P., Van Houten, M. A., Van Der Schoor, S. R. D., Salvesen, B., Schneider, M., Nestaas, E., Nakstad, B., Karpinski, L., Gulczynska, E., Krolak-Olejnik, B., Bokiniec, R., Vilan, A. I., De Pinho, L. F., Ferraz, C., Pereira, A., Barroso, R., Da Graca, A. M., Tome, T., Pinto, F., Rodilla, J. M., Lubian, S., Camprubi, M. C., Suazo, J. A. H., Valverde, E., Lorenzo, J. R. F., Orgado, J. M., Boix, H., Parrilla, F. J., Moral-Pumarega, M. T., Maletzki, J., Knoepfli, C., Hagmann, C., Schulzke, S., Stocker, M., Birkenmaier, A., Riedel, T., Ehni, H. -J., Janvier, A., Marckmann, G., and Vento G. (ORCID:0000-0002-8132-5127)

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 d

Published
2019

3. Supplementary Material for: Inhaled Glucocorticoids and Pneumonia in Preterm Infants: Post Hoc Results from the NEuroSIS Trial

Author

Koch, A., Kreutzer, K., Von Oldershausen, G., Poets, C.F., Bassler, D., and Group, On Behalf Of The NEuroSIS Trial

Abstract

Background: Inhaled glucocorticoids may increase the risk of pneumonia in adults. Thus, respiratory infections may be a potential explanation for the non-significantly increased mortality seen in the glucocorticoid group in the largest randomized trial on inhaled glucocorticoids for preventing bronchopulmonary dysplasia in preterm infants published to date (NEuroSIS). Objective: To evaluate the effect of inhaled budesonide on the risk of death due to respiratory infections in the NEuroSIS trial. Methods: We performed post hoc analyses of prospectively collected data from 856 preterm infants on presumed but not culture-proven sepsis and antimicrobial drug use. Additionally, pulmonary complications reported on adverse event forms, death certificates and autopsy reports were compared between study groups. Results: Treatment groups did not differ in the number of episodes with suspected sepsis (184/437 [42.1%] in the budesonide vs. 171/419 [40.8%] in the placebo group). Neither the number of patients receiving antimicrobial drugs nor the length of antimicrobial treatment differed between groups. Our analyses for pulmonary adverse events as well as for pulmonary complications reported on death certificates and autopsy reports did not suggest a negative impact of inhaled budesonide on these outcomes. Conclusion: The current analysis does not support the assumption that respiratory tract infections explain the increased mortality seen in the glucocorticoid group in the NEuroSIS trial.

Published
2017
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4. Inhaled Glucocorticoids and Pneumonia in Preterm Infants: Post Hoc Results from the NEuroSIS Trial.

Author

Koch A, Kreutzer K, von Oldershausen G, Poets CF, and Bassler D

Subjects
Administration, Inhalation, Anti-Infective Agents administration & dosage, Bronchopulmonary Dysplasia diagnosis, Bronchopulmonary Dysplasia etiology, Bronchopulmonary Dysplasia mortality, Budesonide administration & dosage, Cause of Death, Gestational Age, Glucocorticoids administration & dosage, Humans, Infant, Newborn, Pneumonia diagnosis, Pneumonia mortality, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Bronchopulmonary Dysplasia prevention & control, Budesonide adverse effects, Glucocorticoids adverse effects, Infant, Premature, Pneumonia chemically induced
Abstract

Background: Inhaled glucocorticoids may increase the risk of pneumonia in adults. Thus, respiratory infections may be a potential explanation for the non-significantly increased mortality seen in the glucocorticoid group in the largest randomized trial on inhaled glucocorticoids for preventing bronchopulmonary dysplasia in preterm infants published to date (NEuroSIS)., Objective: To evaluate the effect of inhaled budesonide on the risk of death due to respiratory infections in the NEuroSIS trial., Methods: We performed post hoc analyses of prospectively collected data from 856 preterm infants on presumed but not culture-proven sepsis and antimicrobial drug use. Additionally, pulmonary complications reported on adverse event forms, death certificates and autopsy reports were compared between study groups., Results: Treatment groups did not differ in the number of episodes with suspected sepsis (184/437 [42.1%] in the budesonide vs. 171/419 [40.8%] in the placebo group). Neither the number of patients receiving antimicrobial drugs nor the length of antimicrobial treatment differed between groups. Our analyses for pulmonary adverse events as well as for pulmonary complications reported on death certificates and autopsy reports did not suggest a negative impact of inhaled budesonide on these outcomes., Conclusion: The current analysis does not support the assumption that respiratory tract infections explain the increased mortality seen in the glucocorticoid group in the NEuroSIS trial., (© 2017 S. Karger AG, Basel.)

Published
2017
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