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1. Pharmacokinetic/Pharmacodynamic Modelling of Allopurinol, its Active Metabolite Oxypurinol, and Biomarkers Hypoxanthine, Xanthine and Uric Acid in Hypoxic-Ischemic Encephalopathy Neonates

Author

Chu, Wan-Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J. N. L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P. C., Allegaert, Karel, and Huitema, Alwin D. R.

Published
2022
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7. Proceedings of the 14th International Newborn Brain Conference: Other forms of brain monitoring, such as NIRS, fMRI, biochemical, etc.

Author

Ali, Sanoj, primary, Altamimi, Talal, additional, Annink, Kim, additional, Bartmann, Peter, additional, Beato, Nina, additional, Belker, Kristina, additional, Ben-David, Danielle, additional, Benders, Manon, additional, Bhattacharya, Soume, additional, Anbu Chakkarapani, Aravanan, additional, Charbonneau, Laurence, additional, Cherkerzian, Sara, additional, Chowdhury, Rasheda Arman, additional, Christou, Helen, additional, de Ribaupierre, Dandrine, additional, Dehaes, Mathieu, additional, Domogalla, Caroline, additional, Duerden, Emma G., additional, El-Dib, Mohamed, additional, Elanbari, Mohammed, additional, Elshibiny, Hoda, additional, Engel, Corinna, additional, Felderhoff, Ursula, additional, Flemmer, Andreas W., additional, Franceschini, Maria Angela, additional, Franz, Axel, additional, Garvey, Aisling, additional, Groenendaal, Floris, additional, Gupta, Samir, additional, Hannon, Katie, additional, Hellström-Westas, Lena, additional, Herber-Jonat, Susanne, additional, Holz, Sandra, additional, Hüning, Britta, additional, Inder, Terrie, additional, Jamil, Asma, additional, Jilson, Treesa, additional, Kebaya, Lilian M.N., additional, Keller, Matthias, additional, Khalifa, Aisha Kamil Mohamed, additional, Kim, Seh Hyun, additional, Kittel, Jochen, additional, Koch, Lutz, additional, Kowalczyk, Alexandra, additional, Kühr, Joachim, additional, St. Lawrence, Keith, additional, Lee, Sarah, additional, Marandyuk, Bohdana, additional, Marlow, Neil, additional, Mayorga, Paula Camila, additional, Meyer, Ron, additional, Meyerink, Paige, additional, Miró, Joaquim, additional, More, Kiran, additional, Munk, Aisha, additional, Munster, Chelsea, additional, Musabi, Melab, additional, Nuyt, Anne-Monique, additional, Peters, Jochen, additional, Plum, Achim, additional, Poirier, Nancy, additional, Pöschl, Johannes, additional, Raboisson, Marie-Josée, additional, Robinson, Jill, additional, Roychaudhuri, Sriya, additional, Rüdiger, Mario, additional, Sarközy, Gergely, additional, Saugstad, Ola D., additional, Segerer, Hugo, additional, Soni, Naharmal, additional, Stein, Anja, additional, Steins-Rang, Carola, additional, Sunwoo, John, additional, Szakmar, Eniko, additional, Tang, Lingkai, additional, Taskin, Erdal, additional, Vahidi, Homa, additional, Waldherr, Sina, additional, Wieg, Christian, additional, Winkler, Stefan, additional, Wu, Rong, additional, Yajamanyam, Phani Kiran, additional, and Yapicioglu-Yildizdas, Hacer, additional

Published
2023
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8. Proceedings of the 14th International Newborn Brain Conference: Other forms of brain monitoring, such as NIRS, fMRI, biochemical, etc

Author

Arts-assistenten Kinderen, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Ali, Sanoj, Altamimi, Talal, Annink, Kim, Bartmann, Peter, Beato, Nina, Belker, Kristina, Ben-David, Danielle, Benders, Manon, Bhattacharya, Soume, Anbu Chakkarapani, Aravanan, Charbonneau, Laurence, Cherkerzian, Sara, Chowdhury, Rasheda Arman, Christou, Helen, de Ribaupierre, Dandrine, Dehaes, Mathieu, Domogalla, Caroline, Duerden, Emma G., El-Dib, Mohamed, Elanbari, Mohammed, Elshibiny, Hoda, Engel, Corinna, Felderhoff, Ursula, Flemmer, Andreas W., Franceschini, Maria Angela, Franz, Axel, Garvey, Aisling, Groenendaal, Floris, Gupta, Samir, Hannon, Katie, Hellström-Westas, Lena, Herber-Jonat, Susanne, Holz, Sandra, Hüning, Britta, Inder, Terrie, Jamil, Asma, Jilson, Treesa, Kebaya, Lilian M.N., Keller, Matthias, Khalifa, Aisha Kamil Mohamed, Kim, Seh Hyun, Kittel, Jochen, Koch, Lutz, Kowalczyk, Alexandra, Kühr, Joachim, St Lawrence, Keith, Lee, Sarah, Marandyuk, Bohdana, Marlow, Neil, Mayorga, Paula Camila, Meyer, Ron, Meyerink, Paige, Miró, Joaquim, More, Kiran, Munk, Aisha, Munster, Chelsea, Musabi, Melab, Nuyt, Anne Monique, Peters, Jochen, Plum, Achim, Poirier, Nancy, Pöschl, Johannes, Raboisson, Marie Josée, Robinson, Jill, Roychaudhuri, Sriya, Rüdiger, Mario, Sarközy, Gergely, Saugstad, Ola D., Segerer, Hugo, Soni, Naharmal, Stein, Anja, Steins-Rang, Carola, Sunwoo, John, Szakmar, Eniko, Tang, Lingkai, Taskin, Erdal, Vahidi, Homa, Waldherr, Sina, Wieg, Christian, Winkler, Stefan, Wu, Rong, Yajamanyam, Phani Kiran, Yapicioglu-Yildizdas, Hacer, Arts-assistenten Kinderen, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Ali, Sanoj, Altamimi, Talal, Annink, Kim, Bartmann, Peter, Beato, Nina, Belker, Kristina, Ben-David, Danielle, Benders, Manon, Bhattacharya, Soume, Anbu Chakkarapani, Aravanan, Charbonneau, Laurence, Cherkerzian, Sara, Chowdhury, Rasheda Arman, Christou, Helen, de Ribaupierre, Dandrine, Dehaes, Mathieu, Domogalla, Caroline, Duerden, Emma G., El-Dib, Mohamed, Elanbari, Mohammed, Elshibiny, Hoda, Engel, Corinna, Felderhoff, Ursula, Flemmer, Andreas W., Franceschini, Maria Angela, Franz, Axel, Garvey, Aisling, Groenendaal, Floris, Gupta, Samir, Hannon, Katie, Hellström-Westas, Lena, Herber-Jonat, Susanne, Holz, Sandra, Hüning, Britta, Inder, Terrie, Jamil, Asma, Jilson, Treesa, Kebaya, Lilian M.N., Keller, Matthias, Khalifa, Aisha Kamil Mohamed, Kim, Seh Hyun, Kittel, Jochen, Koch, Lutz, Kowalczyk, Alexandra, Kühr, Joachim, St Lawrence, Keith, Lee, Sarah, Marandyuk, Bohdana, Marlow, Neil, Mayorga, Paula Camila, Meyer, Ron, Meyerink, Paige, Miró, Joaquim, More, Kiran, Munk, Aisha, Munster, Chelsea, Musabi, Melab, Nuyt, Anne Monique, Peters, Jochen, Plum, Achim, Poirier, Nancy, Pöschl, Johannes, Raboisson, Marie Josée, Robinson, Jill, Roychaudhuri, Sriya, Rüdiger, Mario, Sarközy, Gergely, Saugstad, Ola D., Segerer, Hugo, Soni, Naharmal, Stein, Anja, Steins-Rang, Carola, Sunwoo, John, Szakmar, Eniko, Tang, Lingkai, Taskin, Erdal, Vahidi, Homa, Waldherr, Sina, Wieg, Christian, Winkler, Stefan, Wu, Rong, Yajamanyam, Phani Kiran, and Yapicioglu-Yildizdas, Hacer

Published
2023

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., 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., and for the ALBINO Study Group

Published
2019
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10. Semi-mechanistic Modeling of Hypoxanthine, Xanthine, and Uric Acid Metabolism in Asphyxiated Neonates

Author

Chu, Wan-Yu, Allegaert, Karel, Dorlo, Thomas P. C., Huitema, Alwin D. R., Franz, Axel R., Rüdiger, Mario, Nijstad, Laura, Annink, Kim, Maiwald, Christian, Schroth, Michael, Hagen, Anja, Bakkali, Loubna el, van Weisenbruch, Mirjam M., Poets, Christian F., Benders, Manon, van Bel, Frank, Naulaers, Gunnar, Bassler, Dirk, Klebermass-Schrehof, Katrin, Vento, Maximo, Guimaraes, Hercilia, Stiris, Tom, Mauro, Isabella, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Metsvaht, Tuuli, van der Vlugt-Meijer, Roselinda, and Pharmacy

Subjects
Pharmacology, Hypoxanthine, Xanthine Dehydrogenase, Allopurinol, Clinical Studies as Topic, Infant, Newborn, Oxypurinol, Xanthine, Uric Acid, Other Clinical Medicine, Hypoxia-Ischemia, Brain, Annan klinisk medicin, Humans, Pharmacology (medical), Mannitol, Hypoxia
Abstract

BACKGROUND AND OBJECTIVE: Previously, we developed a pharmacokinetic-pharmacodynamic model of allopurinol, oxypurinol, and biomarkers, hypoxanthine, xanthine, and uric acid, in neonates with hypoxic-ischemic encephalopathy, in which high initial biomarker levels were observed suggesting an impact of hypoxia. However, the full pharmacodynamics could not be elucidated in our previous study. The current study included additional data from the ALBINO study (NCT03162653) placebo group, aiming to characterize the dynamics of hypoxanthine, xanthine, and uric acid in neonates with hypoxic-ischemic encephalopathy. METHODS: Neonates from the ALBINO study who received allopurinol or placebo mannitol were included. An extended population pharmacokinetic-pharmacodynamic model was developed based on the mechanism of purine metabolism, where synthesis, salvage, and degradation via xanthine oxidoreductase pathways were described. The initial level of the biomarkers was a combination of endogenous turnover and high disease-related amounts. Model development was accomplished by nonlinear mixed-effects modeling (NONMEM®, version 7.5). RESULTS: In total, 20 neonates treated with allopurinol and 17 neonates treated with mannitol were included in this analysis. Endogenous synthesis of the biomarkers reduced with 0.43% per hour because of precursor exhaustion. Hypoxanthine was readily salvaged or degraded to xanthine with rate constants of 0.5 1/h (95% confidence interval 0.33-0.77) and 0.2 1/h (95% confidence interval 0.09-0.31), respectively. A greater salvage was found in the allopurinol treatment group consistent with its mechanism of action. High hypoxia-induced initial levels of biomarkers were quantified, and were 1.2-fold to 2.9-fold higher in neonates with moderate-to-severe hypoxic-ischemic encephalopathy compared with those with mild hypoxic-ischemic encephalopathy. Half-maximal xanthine oxidoreductase inhibition was achieved with a combined allopurinol and oxypurinol concentration of 0.68 mg/L (95% confidence interval 0.48-0.92), suggesting full xanthine oxidoreductase inhibition during the period studied. CONCLUSIONS: This extended pharmacokinetic-pharmacodynamic model provided an adequate description of the complex hypoxanthine, xanthine, and uric acid metabolism in neonates with hypoxic-ischemic encephalopathy, suggesting a positive allopurinol effect on these biomarkers. The impact of hypoxia on their dynamics was characterized, underlining higher hypoxia-related initial exposure with a more severe hypoxic-ischemic encephalopathy status. ispartof: CLINICAL PHARMACOKINETICS vol:61 issue:11 pages:1545-1558 ispartof: location:Switzerland status: published

Published
2022

11. Pharmacokinetic/Pharmacodynamic Modelling of Allopurinol, its Active Metabolite Oxypurinol, and Biomarkers Hypoxanthine, Xanthine and Uric Acid in Hypoxic-Ischemic Encephalopathy Neonates

Author

Chu, Wan Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J.N.L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P.C., Allegaert, Karel, Huitema, Alwin D.R., Chu, Wan Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J.N.L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P.C., Allegaert, Karel, and Huitema, Alwin D.R.

Abstract

Background: Allopurinol, an xanthine oxidase (XO) inhibitor, is a promising intervention that may provide neuroprotection for neonates with hypoxic-ischemic encephalopathy (HIE). Currently, a double-blind, placebo-controlled study (ALBINO, NCT03162653) is investigating the neuroprotective effect of allopurinol in HIE neonates. Objective: The aim of the current study was to establish the pharmacokinetics (PK) of allopurinol and oxypurinol, and the pharmacodynamics (PD) of both compounds on hypoxanthine, xanthine, and uric acid in HIE neonates. The dosage used and the effect of allopurinol in this population, either or not undergoing therapeutic hypothermia (TH), were evaluated. Methods: Forty-six neonates from the ALBINO study and two historical clinical studies were included. All doses were administered on the first day of life. In the ALBINO study (n = 20), neonates received a first dose of allopurinol 20 mg/kg, and, in the case of TH (n = 13), a second dose of allopurinol 10 mg/kg. In the historical cohorts (n = 26), neonates (all without TH) received two doses of allopurinol 20 mg/kg in total. Allopurinol and oxypurinol population PK, and their effects on inhibiting conversions of hypoxanthine and xanthine to uric acid, were assessed using nonlinear mixed-effects modelling. Results: Allopurinol and oxypurinol PK were described by two sequential one-compartment models with an autoinhibition effect on allopurinol metabolism by oxypurinol. For allopurinol, clearance (CL) was 0.83 L/h (95% confidence interval [CI] 0.62–1.09) and volume of distribution (Vd) was 2.43 L (95% CI 2.25–2.63). For metabolite oxypurinol, CL and Vd relative to a formation fraction (fm) were 0.26 L/h (95% CI 0.23–0.3) and 11 L (95% CI 9.9–12.2), respectively. No difference in allopurinol and oxypurinol CL was found between TH and non-TH patients. The effect of allopurinol and oxypurinol on XO inhibition was described by a turnover

Published
2022

12. Proceedings of the 14th International Newborn Brain Conference: Other forms of brain monitoring, such as NIRS, fMRI, biochemical, etc.

Author

Ali, Sanoj, Altamimi, Talal, Annink, Kim, Bartmann, Peter, Beato, Nina, Belker, Kristina, Ben-David, Danielle, Benders, Manon, Bhattacharya, Soume, Anbu Chakkarapani, Aravanan, Charbonneau, Laurence, Cherkerzian, Sara, Chowdhury, Rasheda Arman, Christou, Helen, de Ribaupierre, Dandrine, Dehaes, Mathieu, Domogalla, Caroline, Duerden, Emma G., El-Dib, Mohamed, and Elanbari, Mohammed

Subjects
CEREBRAL anoxia-ischemia, NEWBORN infants, MEDICAL sciences, NEAR infrared spectroscopy, NEUROSCIENCES, FUNCTIONAL magnetic resonance imaging
Abstract

The pattern of brain injury was evaluated according to an MRI grading system developed by Weeke et. al. tcPCO2, rSO2 and bedside physiological data were captured simultaneously by a real-time integrated neuromonitoring system (CNS Monitor). Though small in effect size, correlations were stronger among infants with brain injury (tcPCO2/rSO2 r= 0.19; tcPCO2/FTOE r= -0.15) compared to those without brain injury on MRI (tcPCO2/rSO2 r= 0.08; tcPCO2/FTOE r=-0.04) (Figure 2). [Extracted from the article]

Published
2023
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13. Pharmacokinetic/Pharmacodynamic Modelling of Allopurinol, its Active Metabolite Oxypurinol, and Biomarkers Hypoxanthine, Xanthine and Uric Acid in Hypoxic-Ischemic Encephalopathy Neonates

Author

Chu, Wan-Yu, Annink, Kim V., Nijstad, A. Laura, Maiwald, Christian A., Schroth, Michael, Bakkali, Loubna el, van Bel, Frank, Benders, Manon J. N. L., van Weissenbruch, Mirjam M., Hagen, Anja, Franz, Axel R., Dorlo, Thomas P. C., Allegaert, Karel, Huitema, Alwin D. R., Rüdiger, Mario, Poets, Christian F., Naulaers, Gunnar, Bassler, Dirk, Klebermass-Schrehof, Katrin, Vento, Maximo, Guimaraes, Hercilia, Stiris, Tom, Mauro, Isabella, Metsäranta, Marjo, Vanhatalo, Sampsa, Mazela, Jan, Jacobs, Yannique, Pharmacy, Pediatric surgery, Amsterdam Gastroenterology Endocrinology Metabolism, and Amsterdam Reproduction & Development (AR&D)

Subjects
Xanthine Oxidase, Allopurinol, Population, INHIBITION, Oxypurinol, Pharmacology, OXIDASE, ASPHYXIA, Xanthine, BRAIN-DAMAGE, chemistry.chemical_compound, Pharmacokinetics, Humans, Medicine, Pharmacology (medical), Pharmacology & Pharmacy, Enzyme Inhibitors, Xanthine oxidase, education, Hypoxanthine, HYPOTHERMIA, education.field_of_study, Science & Technology, business.industry, Infant, Newborn, nutritional and metabolic diseases, PHARMACODYNAMICS, POPULATION PHARMACOKINETICS, RENAL CLEARANCE, Uric Acid, chemistry, Pharmacodynamics, Hypoxia-Ischemia, Brain, Uric acid, CLINICAL PHARMACOKINETICS, business, Life Sciences & Biomedicine, Biomarkers, DEFEROXAMINE, medicine.drug
Abstract

BACKGROUND: Allopurinol, an xanthine oxidase (XO) inhibitor, is a promising intervention that may provide neuroprotection for neonates with hypoxic-ischemic encephalopathy (HIE). Currently, a double-blind, placebo-controlled study (ALBINO, NCT03162653) is investigating the neuroprotective effect of allopurinol in HIE neonates. OBJECTIVE: The aim of the current study was to establish the pharmacokinetics (PK) of allopurinol and oxypurinol, and the pharmacodynamics (PD) of both compounds on hypoxanthine, xanthine, and uric acid in HIE neonates. The dosage used and the effect of allopurinol in this population, either or not undergoing therapeutic hypothermia (TH), were evaluated. METHODS: Forty-six neonates from the ALBINO study and two historical clinical studies were included. All doses were administered on the first day of life. In the ALBINO study (n = 20), neonates received a first dose of allopurinol 20 mg/kg, and, in the case of TH (n = 13), a second dose of allopurinol 10 mg/kg. In the historical cohorts (n = 26), neonates (all without TH) received two doses of allopurinol 20 mg/kg in total. Allopurinol and oxypurinol population PK, and their effects on inhibiting conversions of hypoxanthine and xanthine to uric acid, were assessed using nonlinear mixed-effects modelling. RESULTS: Allopurinol and oxypurinol PK were described by two sequential one-compartment models with an autoinhibition effect on allopurinol metabolism by oxypurinol. For allopurinol, clearance (CL) was 0.83 L/h (95% confidence interval [CI] 0.62-1.09) and volume of distribution (Vd) was 2.43 L (95% CI 2.25-2.63). For metabolite oxypurinol, CL and Vd relative to a formation fraction (fm) were 0.26 L/h (95% CI 0.23-0.3) and 11 L (95% CI 9.9-12.2), respectively. No difference in allopurinol and oxypurinol CL was found between TH and non-TH patients. The effect of allopurinol and oxypurinol on XO inhibition was described by a turnover model of hypoxanthine with sequential metabolites xanthine and uric acid. The combined allopurinol and oxypurinol concentration at the half-maximal XO inhibition was 0.36 mg/L (95% CI 0.31-0.42). CONCLUSION: The PK and PD of allopurinol, oxypurinol, hypoxanthine, xanthine, and uric acid in neonates with HIE were described. The dosing regimen applied in the ALBINO trial leads to the targeted XO inhibition in neonates treated with or without TH. ispartof: CLINICAL PHARMACOKINETICS vol:61 issue:2 pages:321-333 ispartof: location:Switzerland status: published

Published
2021
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14. Glomerular Filtration Rate in Asphyxiated Neonates Under Therapeutic Whole-Body Hypothermia, Quantified by Mannitol Clearance

Author

Deferm, Neel, Annink, Kim V, Faelens, Ruben, Schroth, Michael, Maiwald, Christian A, Bakkali, Loubna El, van Bel, Frank, Benders, Manon J N L, van Weissenbruch, Mirjam M, Hagen, Anja, Smits, Anne, Annaert, Pieter, Franz, Axel R, Allegaert, Karel; https://orcid.org/0000-0001-9921-5105, ALBINO Study Group, Deferm, Neel, Annink, Kim V, Faelens, Ruben, Schroth, Michael, Maiwald, Christian A, Bakkali, Loubna El, van Bel, Frank, Benders, Manon J N L, van Weissenbruch, Mirjam M, Hagen, Anja, Smits, Anne, Annaert, Pieter, Franz, Axel R, Allegaert, Karel; https://orcid.org/0000-0001-9921-5105, and ALBINO Study Group

Abstract

BACKGROUND Therapeutic hypothermia (TH) is an established intervention to improve the outcome of neonates with moderate-to-severe hypoxic-ischemic encephalopathy resulting from perinatal asphyxia. Despite this beneficial effect, TH may further affect drug elimination pathways such as the glomerular filtration rate. OBJECTIVES The objective of this study was to quantify the effect of TH in addition to asphyxia on mannitol clearance as a surrogate for the glomerular filtration rate. METHODS The effect of asphyxia and TH (mild vs moderate/severe) on mannitol clearance was assessed using a population approach, based on mannitol observations collected in the ALBINO (ALlopurinol in addition to TH for hypoxic-ischemic Brain Injury on Neurocognitive Outcome) trial, as some were exposed to a second dose of 10 mg/kg intravenous mannitol as placebo to ensure blinding. Pharmacokinetic analysis and model development were conducted using NONMEM version 7.4. RESULTS Based on 77 observations from 17 neonates (TH = 13), a one-compartment model with first-order linear elimination best described the observed data. To account for prenatal glomerular filtration rate maturation, both birthweight and gestational age were implemented as clearance covariates using an earlier published three-quarters power function and a sigmoid hyperbolic function. Our final model predicted a mannitol clearance of 0.15 L/h for a typical asphyxia neonate (39.5 weeks, birthweight 3.25 kg, no TH), lower than the reported value of 0.33 L/h for a healthy neonate of similar age and weight. By introducing TH as a binary covariate on clearance, the additional impact of TH on mannitol clearance was quantified (60% decrease). CONCLUSIONS Mannitol clearance was decreased by approximately 60% in neonates undergoing TH, although this is likely confounded with asphyxia severity. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT03162653.

Published
2021

15. Pathophysiology of Cerebral Hyperperfusion in Term Neonates With Hypoxic-Ischemic Encephalopathy: A Systematic Review for Future Research

Author

MS Neonatologie, Brain, Child Health, Infection & Immunity, Arts-assistenten Kinderen, Circulatory Health, Regenerative Medicine and Stem Cells, Kleuskens, Dianne G, Gonçalves Costa, Filipe, Annink, Kim V, van den Hoogen, Agnes, Alderliesten, Thomas, Groenendaal, Floris, Benders, Manon J N, Dudink, Jeroen, MS Neonatologie, Brain, Child Health, Infection & Immunity, Arts-assistenten Kinderen, Circulatory Health, Regenerative Medicine and Stem Cells, Kleuskens, Dianne G, Gonçalves Costa, Filipe, Annink, Kim V, van den Hoogen, Agnes, Alderliesten, Thomas, Groenendaal, Floris, Benders, Manon J N, and Dudink, Jeroen

Published
2021

16. Mammillary body atrophy and other MRI correlates of school-age outcome following neonatal hypoxic-ischemic encephalopathy

Author

MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Kinderbewegingszorg patientenzorg, Psychosociale zorg patientenzorg, Other research (not in main researchprogram), MS Radiologie, Circulatory Health, Annink, Kim V, de Vries, Linda S, Groenendaal, Floris, Eijsermans, Rian M J C, Mocking, Manouk, van Schooneveld, Monique M J, Dudink, Jeroen, van Straaten, Henrica L M, Benders, Manon J N L, Lequin, Maarten, van der Aa, Niek E, MS Neonatologie, Brain, Child Health, Regenerative Medicine and Stem Cells, Kinderbewegingszorg patientenzorg, Psychosociale zorg patientenzorg, Other research (not in main researchprogram), MS Radiologie, Circulatory Health, Annink, Kim V, de Vries, Linda S, Groenendaal, Floris, Eijsermans, Rian M J C, Mocking, Manouk, van Schooneveld, Monique M J, Dudink, Jeroen, van Straaten, Henrica L M, Benders, Manon J N L, Lequin, Maarten, and van der Aa, Niek E

Published
2021

17. The development and validation of a cerebral ultrasound scoring system for infants with hypoxic-ischaemic encephalopathy

Author

Annink, Kim, Vries, Linda de, Groenendaal, Floris, Vijlbrief, Daniel, Weeke, Lauren, Roehr, Charles, Lequin, Maarten, Reiss, Irwin K M, Govaert, Paul, Benders, Manon, Dudink, Jeroen, Annink, Kim, Vries, Linda de, Groenendaal, Floris, Vijlbrief, Daniel, Weeke, Lauren, Roehr, Charles, Lequin, Maarten, Reiss, Irwin K M, Govaert, Paul, Benders, Manon, and Dudink, Jeroen

Published
2020

18. Cerebellar injury in term neonates with hypoxic–ischemic encephalopathy is underestimated

Author

Annink, Kim V., Meerts, Lilly, Aa, Niek E. van der, Alderliesten, Thomas, Nikkels, Peter G. J., Nijboer, Cora H. A., Groenendaal, Floris, Vries, Linda S. de, Benders, Manon J. N. L., Hoebeek, Freek E., Dudink, Jeroen, Annink, Kim V., Meerts, Lilly, Aa, Niek E. van der, Alderliesten, Thomas, Nikkels, Peter G. J., Nijboer, Cora H. A., Groenendaal, Floris, Vries, Linda S. de, Benders, Manon J. N. L., Hoebeek, Freek E., and Dudink, Jeroen

Published
2020

22. 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, ALBINO Study Group, University of Zurich, and Franz, Axel R

Subjects
Hypothermia therapy, Perinatal asphyxia, Allopurinol, Neonatal oxygen deficiency, Hypoxic-ischemic encephalopathy, lcsh:RJ1-570, Allopurinol, Neonatal oxygen deficiency, Hypothermia therapy, Childbirth outcome, Hypoxic-ischemic encephalopathy, Perinatal asphyxia, Brain injury, Cerebral palsy, lcsh:Pediatrics, 610 Medicine & health, 2735 Pediatrics, Perinatology and Child Health, Childbirth outcome, 10027 Clinic for Neonatology
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

23. 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

24. 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

25. In silico validation of the autoinflammatory disease damage index

Author

Ter Haar, Nienke M., Van Delft, Amber Laetitia Justine, Annink, Kim Valerie, Van Stel, Henk, Al-Mayouf, Sulaiman M., Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne, Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, De Jesus, Adriana Almeida, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L., Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M., Insalaco, Antonella, Jansson, Annette F., Kallinich, Tilmann, Kone-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin Beate, Lachmann, Helen J., Laxer, Ronald M., Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K., Özen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Schulert, Grant, Gattorno, Marco, Frenkel, Joost, Ter Haar, Nienke M., Van Delft, Amber Laetitia Justine, Annink, Kim Valerie, Van Stel, Henk, Al-Mayouf, Sulaiman M., Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne, Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, De Jesus, Adriana Almeida, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L., Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M., Insalaco, Antonella, Jansson, Annette F., Kallinich, Tilmann, Kone-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin Beate, Lachmann, Helen J., Laxer, Ronald M., Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K., Özen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Schulert, Grant, Gattorno, Marco, and Frenkel, Joost

Published
2018

26. In silico validation of the autoinflammatory disease damage index

Author

Infection & Immunity, Child Health, CTI Vastert, MS Neonatologie, Brain, JC onderzoeksprogramma Methodologie, Other research (not in main researchprogram), Verplegingswetenschap, Arts-assistenten Kinderen, Ter Haar, Nienke M., Van Delft, Amber Laetitia Justine, Annink, Kim Valerie, Van Stel, Henk, Al-Mayouf, Sulaiman M., Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne, Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, De Jesus, Adriana Almeida, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L., Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M., Insalaco, Antonella, Jansson, Annette F., Kallinich, Tilmann, Kone-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin Beate, Lachmann, Helen J., Laxer, Ronald M., Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K., Özen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Schulert, Grant, Gattorno, Marco, Frenkel, Joost, Infection & Immunity, Child Health, CTI Vastert, MS Neonatologie, Brain, JC onderzoeksprogramma Methodologie, Other research (not in main researchprogram), Verplegingswetenschap, Arts-assistenten Kinderen, Ter Haar, Nienke M., Van Delft, Amber Laetitia Justine, Annink, Kim Valerie, Van Stel, Henk, Al-Mayouf, Sulaiman M., Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne, Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, De Jesus, Adriana Almeida, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L., Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M., Insalaco, Antonella, Jansson, Annette F., Kallinich, Tilmann, Kone-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin Beate, Lachmann, Helen J., Laxer, Ronald M., Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K., Özen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Schulert, Grant, Gattorno, Marco, and Frenkel, Joost

Published
2018

28. In silico validation of the Autoinflammatory Disease Damage Index

Author

ter Haar, Nienke M, primary, van Delft, Amber Laetitia Justine, additional, Annink, Kim Valerie, additional, van Stel, Henk, additional, Al-Mayouf, Sulaiman M, additional, Amaryan, Gayane, additional, Anton, Jordi, additional, Barron, Karyl S, additional, Benseler, Susanne, additional, Brogan, Paul A, additional, Cantarini, Luca, additional, Cattalini, Marco, additional, Cochino, Alexis-Virgil, additional, de Benedetti, Fabrizio, additional, Dedeoglu, Fatma, additional, de Jesus, Adriana Almeida, additional, Demirkaya, Erkan, additional, Dolezalova, Pavla, additional, Durrant, Karen L, additional, Fabio, Giovanna, additional, Gallizzi, Romina, additional, Goldbach-Mansky, Raphaela, additional, Hachulla, Eric, additional, Hentgen, Veronique, additional, Herlin, Troels, additional, Hofer, Michaël, additional, Hoffman, Hal M, additional, Insalaco, Antonella, additional, Jansson, Annette F, additional, Kallinich, Tilmann, additional, Kone-Paut, Isabelle, additional, Kozlova, Anna, additional, Kuemmerle-Deschner, Jasmin Beate, additional, Lachmann, Helen J, additional, Laxer, Ronald M, additional, Martini, Alberto, additional, Nielsen, Susan, additional, Nikishina, Irina, additional, Ombrello, Amanda K, additional, Özen, Seza, additional, Papadopoulou-Alataki, Efimia, additional, Quartier, Pierre, additional, Rigante, Donato, additional, Russo, Ricardo, additional, Simon, Anna, additional, Trachana, Maria, additional, Uziel, Yosef, additional, Ravelli, Angelo, additional, Schulert, Grant, additional, Gattorno, Marco, additional, and Frenkel, Joost, additional

Published
2018
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29. The long-term effect of perinatal asphyxia on hippocampal volumes

Author

Annink, Kim V., primary, de Vries, Linda S., additional, Groenendaal, Floris, additional, van den Heuvel, Martijn P., additional, van Haren, Neeltje E. M., additional, Swaab, Hanna, additional, van Handel, Mariëlle, additional, Jongmans, Marian J., additional, Benders, Manon J., additional, and van der Aa, Niek E., additional

Published
2018
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31. Development of the autoinflammatory disease damage index (ADDI)

Author

Ter Haar, Nienke M., Annink, Kim V., Al-Mayouf, Sulaiman M, Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne M., Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis-Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, de Jesus, Adriana Almeida, Della Casa Alberighi, Ornella, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L, Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M, Insalaco, Antonella, Jansson, Annette F, Kallinich, Tilmann, Koné-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin B., Lachmann, Helen J., Laxer, Ronald M, Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K, Ozen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Gattorno, Marco, Frenkel, Joost, Ter Haar, Nienke M., Annink, Kim V., Al-Mayouf, Sulaiman M, Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne M., Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis-Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, de Jesus, Adriana Almeida, Della Casa Alberighi, Ornella, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L, Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M, Insalaco, Antonella, Jansson, Annette F, Kallinich, Tilmann, Koné-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin B., Lachmann, Helen J., Laxer, Ronald M, Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K, Ozen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Gattorno, Marco, and Frenkel, Joost

Published
2017

32. Allopurinol: Old Drug, New Indication in Neonates?

Author

Annink, Kim V., Franz, Axel R., Derks, Jan B., Rüdiger, Mario, Bel, Frank van, Benders, Manon J. N. L., Annink, Kim V., Franz, Axel R., Derks, Jan B., Rüdiger, Mario, Bel, Frank van, and Benders, Manon J. N. L.

Published
2017

34. Development of the autoinflammatory disease damage index (ADDI)

Author

CDL Patiëntenzorg MI, Infection & Immunity, Child Health, Arts-assistenten Kinderen, Ter Haar, Nienke M., Annink, Kim V., Al-Mayouf, Sulaiman M, Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne M., Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis-Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, de Jesus, Adriana Almeida, Della Casa Alberighi, Ornella, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L, Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M, Insalaco, Antonella, Jansson, Annette F, Kallinich, Tilmann, Koné-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin B., Lachmann, Helen J., Laxer, Ronald M, Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K, Ozen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Gattorno, Marco, Frenkel, Joost, CDL Patiëntenzorg MI, Infection & Immunity, Child Health, Arts-assistenten Kinderen, Ter Haar, Nienke M., Annink, Kim V., Al-Mayouf, Sulaiman M, Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne M., Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis-Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, de Jesus, Adriana Almeida, Della Casa Alberighi, Ornella, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L, Fabio, Giovanna, Gallizzi, Romina, Goldbach-Mansky, Raphaela, Hachulla, Eric, Hentgen, Veronique, Herlin, Troels, Hofer, Michaël, Hoffman, Hal M, Insalaco, Antonella, Jansson, Annette F, Kallinich, Tilmann, Koné-Paut, Isabelle, Kozlova, Anna, Kuemmerle-Deschner, Jasmin B., Lachmann, Helen J., Laxer, Ronald M, Martini, Alberto, Nielsen, Susan, Nikishina, Irina, Ombrello, Amanda K, Ozen, Seza, Papadopoulou-Alataki, Efimia, Quartier, Pierre, Rigante, Donato, Russo, Ricardo, Simon, Anna, Trachana, Maria, Uziel, Yosef, Ravelli, Angelo, Gattorno, Marco, and Frenkel, Joost

Published
2017

35. Development of the autoinflammatory disease damage index (ADDI)

Author

ter Haar, Nienke M, primary, Annink, Kim V, additional, Al-Mayouf, Sulaiman M, additional, Amaryan, Gayane, additional, Anton, Jordi, additional, Barron, Karyl S, additional, Benseler, Susanne M, additional, Brogan, Paul A, additional, Cantarini, Luca, additional, Cattalini, Marco, additional, Cochino, Alexis-Virgil, additional, De Benedetti, Fabrizio, additional, Dedeoglu, Fatma, additional, De Jesus, Adriana A, additional, Della Casa Alberighi, Ornella, additional, Demirkaya, Erkan, additional, Dolezalova, Pavla, additional, Durrant, Karen L, additional, Fabio, Giovanna, additional, Gallizzi, Romina, additional, Goldbach-Mansky, Raphaela, additional, Hachulla, Eric, additional, Hentgen, Veronique, additional, Herlin, Troels, additional, Hofer, Michaël, additional, Hoffman, Hal M, additional, Insalaco, Antonella, additional, Jansson, Annette F, additional, Kallinich, Tilmann, additional, Koné-Paut, Isabelle, additional, Kozlova, Anna, additional, Kuemmerle-Deschner, Jasmin B, additional, Lachmann, Helen J, additional, Laxer, Ronald M, additional, Martini, Alberto, additional, Nielsen, Susan, additional, Nikishina, Irina, additional, Ombrello, Amanda K, additional, Ozen, Seza, additional, Papadopoulou-Alataki, Efimia, additional, Quartier, Pierre, additional, Rigante, Donato, additional, Russo, Ricardo, additional, Simon, Anna, additional, Trachana, Maria, additional, Uziel, Yosef, additional, Ravelli, Angelo, additional, Gattorno, Marco, additional, and Frenkel, Joost, additional

Published
2016
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36. Development of the autoinflammatory disease damage index (ADDI).

Author

Haar, Nienke M. ter, Annink, Kim V., Al-Mayouf, Sulaiman M., Amaryan, Gayane, Anton, Jordi, Barron, Karyl S., Benseler, Susanne M., Brogan, Paul A., Cantarini, Luca, Cattalini, Marco, Cochino, Alexis-Virgil, De Benedetti, Fabrizio, Dedeoglu, Fatma, De Jesus, Adriana A., Alberighi, Ornella Della Casa, Demirkaya, Erkan, Dolezalova, Pavla, Durrant, Karen L., Fabio, Giovanna, and Gallizzi, Romina

Subjects
CONSENSUS (Social sciences), FEVER, GENETIC disorders, INFLAMMATION, LITERATURE, SEVERITY of illness index, DISEASE complications
Abstract

Objectives: Autoinflammatory diseases cause systemic inflammation that can result in damage to multiple organs. A validated instrument is essential to quantify damage in individual patients and to compare disease outcomes in clinical studies. Currently, there is no such tool. Our objective was to develop a common autoinflammatory disease damage index (ADDI) for familial Mediterranean fever, cryopyrin-associated periodic syndromes, tumour necrosis factor receptor-associated periodic fever syndrome and mevalonate kinase deficiency.Methods: We developed the ADDI by consensus building. The top 40 enrollers of patients in the Eurofever Registry and 9 experts from the Americas participated in multiple rounds of online surveys to select items and definitions. Further, 22 (parents of) patients rated damage items and suggested new items. A consensus meeting was held to refine the items and definitions, which were then formally weighted in a scoring system derived using decision-making software, known as 1000minds.Results: More than 80% of the experts and patients completed the online surveys. The preliminary ADDI contains 18 items, categorised in the following eight organ systems: reproductive, renal/amyloidosis, developmental, serosal, neurological, ears, ocular and musculoskeletal damage. The categories renal/amyloidosis and neurological damage were assigned the highest number of points, serosal damage the lowest number of points. The involvement of (parents of) patients resulted in the inclusion of, for example, chronic musculoskeletal pain.Conclusions: An instrument to measure damage caused by autoinflammatory diseases is developed based on consensus building. Patients fulfilled a significant role in this process. [ABSTRACT FROM AUTHOR]

Published
2017
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38. Vital Signs, Temperature and COMFORT Scale Scores in Infants During Ultra-High-Field MR Imaging.

Author

van Ooijen, Inge, primary, Annink, Kim, additional, Dudink, Jeroen, additional, Alderliesten, Thomas, additional, Groenendaal, Floris, additional, Tataranno, Maria Luisa, additional, Lequin, Maarten, additional, Hoogduin, Hans, additional, Visser, Frederik, additional, Raaijmakers, Alexander, additional, Klomp, Dennis, additional, Wiegers, Evita, additional, Benders, Manon, additional, Wijnen, Jannie, additional, and van der Aa, Niek, additional

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39. Glomerular Filtration Rate in Asphyxiated Neonates Under Therapeutic Whole-Body Hypothermia, Quantified by Mannitol Clearance.

Author

Deferm N, Annink KV, Faelens R, Schroth M, Maiwald CA, Bakkali LE, van Bel F, Benders MJNL, van Weissenbruch MM, Hagen A, Smits A, Annaert P, Franz AR, and Allegaert K

Subjects
Female, Glomerular Filtration Rate, Humans, Infant, Newborn, Mannitol, Pregnancy, Asphyxia Neonatorum therapy, Hypothermia, Hypothermia, Induced, Hypoxia-Ischemia, Brain therapy
Abstract

Background: Therapeutic hypothermia (TH) is an established intervention to improve the outcome of neonates with moderate-to-severe hypoxic-ischemic encephalopathy resulting from perinatal asphyxia. Despite this beneficial effect, TH may further affect drug elimination pathways such as the glomerular filtration rate., Objectives: The objective of this study was to quantify the effect of TH in addition to asphyxia on mannitol clearance as a surrogate for the glomerular filtration rate., Methods: The effect of asphyxia and TH (mild vs moderate/severe) on mannitol clearance was assessed using a population approach, based on mannitol observations collected in the ALBINO (ALlopurinol in addition to TH for hypoxic-ischemic Brain Injury on Neurocognitive Outcome) trial, as some were exposed to a second dose of 10 mg/kg intravenous mannitol as placebo to ensure blinding. Pharmacokinetic analysis and model development were conducted using NONMEM version 7.4., Results: Based on 77 observations from 17 neonates (TH = 13), a one-compartment model with first-order linear elimination best described the observed data. To account for prenatal glomerular filtration rate maturation, both birthweight and gestational age were implemented as clearance covariates using an earlier published three-quarters power function and a sigmoid hyperbolic function. Our final model predicted a mannitol clearance of 0.15 L/h for a typical asphyxia neonate (39.5 weeks, birthweight 3.25 kg, no TH), lower than the reported value of 0.33 L/h for a healthy neonate of similar age and weight. By introducing TH as a binary covariate on clearance, the additional impact of TH on mannitol clearance was quantified (60% decrease)., Conclusions: Mannitol clearance was decreased by approximately 60% in neonates undergoing TH, although this is likely confounded with asphyxia severity., Trial Registration: ClinicalTrials.gov identifier NCT03162653.

Published
2021
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41. Development of the autoinflammatory disease damage index (ADDI).

Author

Ter Haar NM, Annink KV, Al-Mayouf SM, Amaryan G, Anton J, Barron KS, Benseler SM, Brogan PA, Cantarini L, Cattalini M, Cochino AV, De Benedetti F, Dedeoglu F, De Jesus AA, Della Casa Alberighi O, Demirkaya E, Dolezalova P, Durrant KL, Fabio G, Gallizzi R, Goldbach-Mansky R, Hachulla E, Hentgen V, Herlin T, Hofer M, Hoffman HM, Insalaco A, Jansson AF, Kallinich T, Koné-Paut I, Kozlova A, Kuemmerle-Deschner JB, Lachmann HJ, Laxer RM, Martini A, Nielsen S, Nikishina I, Ombrello AK, Ozen S, Papadopoulou-Alataki E, Quartier P, Rigante D, Russo R, Simon A, Trachana M, Uziel Y, Ravelli A, Gattorno M, and Frenkel J

Subjects
Adolescent, Adult, Aged, Child, Child, Preschool, Consensus, Humans, Middle Aged, Review Literature as Topic, Surveys and Questionnaires, Young Adult, Fever complications, Hereditary Autoinflammatory Diseases complications, Severity of Illness Index
Abstract

Objectives: Autoinflammatory diseases cause systemic inflammation that can result in damage to multiple organs. A validated instrument is essential to quantify damage in individual patients and to compare disease outcomes in clinical studies. Currently, there is no such tool. Our objective was to develop a common autoinflammatory disease damage index (ADDI) for familial Mediterranean fever, cryopyrin-associated periodic syndromes, tumour necrosis factor receptor-associated periodic fever syndrome and mevalonate kinase deficiency., Methods: We developed the ADDI by consensus building. The top 40 enrollers of patients in the Eurofever Registry and 9 experts from the Americas participated in multiple rounds of online surveys to select items and definitions. Further, 22 (parents of) patients rated damage items and suggested new items. A consensus meeting was held to refine the items and definitions, which were then formally weighted in a scoring system derived using decision-making software, known as 1000minds., Results: More than 80% of the experts and patients completed the online surveys. The preliminary ADDI contains 18 items, categorised in the following eight organ systems: reproductive, renal/amyloidosis, developmental, serosal, neurological, ears, ocular and musculoskeletal damage. The categories renal/amyloidosis and neurological damage were assigned the highest number of points, serosal damage the lowest number of points. The involvement of (parents of) patients resulted in the inclusion of, for example, chronic musculoskeletal pain., Conclusions: An instrument to measure damage caused by autoinflammatory diseases is developed based on consensus building. Patients fulfilled a significant role in this process., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Published
2017
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42. Allopurinol: Old Drug, New Indication in Neonates?

Author

Annink KV, Franz AR, Derks JB, Rudiger M, Bel FV, and Benders MJNL

Subjects
Allopurinol pharmacology, Animals, Brain Injuries diagnosis, Brain Injuries drug therapy, Brain Injuries metabolism, Enzyme Inhibitors pharmacology, Enzyme Inhibitors therapeutic use, Free Radical Scavengers pharmacology, Humans, Hypoxia-Ischemia, Brain diagnosis, Hypoxia-Ischemia, Brain metabolism, Infant, Newborn, Xanthine Oxidase metabolism, Allopurinol therapeutic use, Free Radical Scavengers therapeutic use, Hypoxia-Ischemia, Brain drug therapy, Xanthine Oxidase antagonists & inhibitors
Abstract

Background: Hypoxic-ischemic encephalopathy (HIE) is an important cause of neonatal mortality and neurological morbidity, even despite hypothermia treatment. Neuronal damage in these infants is partly caused by the production of superoxides via the xanthine-oxidase pathway and concomitant free radical formation. Allopurinol is a xanthine-oxidase inhibitor and can potentially reduce the formation of these superoxides that lead to brain damage in HIE., Methods: The aim of this review is to provide an overview of the animal and clinical data about the neuroprotective effect of allopurinol in HIE and the relevant mechanisms leading to brain injury in HIE., Results: A possible neuroprotective effect of allopurinol has been suggested based on several preclinical studies in rats, piglets and sheep. Allopurinol seemed to inhibit the formation of superoxide and to scavenge free radicals directly, but the effect on brain damage was inconclusive in these preclinical trials. The neuroprotective effect was also investigated in neonates with HIE. In three small studies, in which, allopurinol was administered postnatally and a pilot and one multi-center study, in which, allopurinol was administered antenatally, a possible beneficial effect was found. After combining the data of 2 postnatal allopurinol studies, long-term follow-up was only beneficial in infants with moderate HIE, therefore, large-scale studies are needed. Additionally, safety, pharmacokinetics and the neuroprotective effect of allopurinol in other neonatal populations are discussed in this review., Conclusion: The available literature is not conclusive whether allopurinol is a neuroprotective add-on therapy in infants with HIE. More research is needed to establish the neuroprotective effect of allopurinol especially in combination with hypothermia., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Published
2017
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43. Health-related quality of life in children with newly diagnosed immune thrombocytopenia.

Author

Heitink-Pollé KM, Haverman L, Annink KV, Schep SJ, de Haas M, and Bruin MC

Subjects
Adolescent, Case-Control Studies, Child, Child, Preschool, Female, Humans, Immunoglobulins, Intravenous therapeutic use, Infant, Male, Parents psychology, Prospective Studies, Purpura, Thrombocytopenic, Idiopathic drug therapy, Purpura, Thrombocytopenic, Idiopathic pathology, Purpura, Thrombocytopenic, Idiopathic physiopathology, Self Report, Surveys and Questionnaires, Purpura, Thrombocytopenic, Idiopathic psychology, Quality of Life
Abstract

Despite its generally transient and benign course, childhood immune thrombocytopenia has a large impact on health-related quality of life. Recently published guidelines state that quality of life should be taken into account while making decisions on management in childhood immune thrombocytopenia. We, therefore, assessed health-related quality of life in children with newly diagnosed immune thrombocytopenia in a prospective multicenter study. One hundred and seven children aged 6 months-16 years (mean age 5.57 years) were included. We used Pediatric Quality of Life Inventory™ and Kids' ITP Tools questionnaires at diagnosis and during standardized follow-up. Scores on the Pediatric Quality of Life Inventory™ Core Scales were compared with those of healthy children. Relationships between health-related quality of life scores and treatment modality, bleeding tendency and course of the disease were examined. Kids' ITP Tools proxy reports and parent self-reports showed significant higher health-related quality of life scores in children who recovered than in children with persistent immune thrombocytopenia (at 3 months: Kids' ITP Tools parent self-report score 80.85 for recovered patients (n=69) versus 58.98 for patients with persistent disease (n=21), P<0.001). No significant differences in health-related quality of life were found between children with mild or moderate bleeding or between children who received intravenous immunoglobulin or children who were carefully observed. In conclusion, health-related quality of life of children with newly diagnosed immune thrombocytopenia is not influenced by treatment modality or bleeding severity, but only by clinical course of the disease. (Dutch Trial Register identifier: NTR TC1563)., (Copyright© Ferrata Storti Foundation.)

Published
2014
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