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News-Archive

Study site in 4 more countries open for recruitment

published: September 5th 2019

During the first half of 2019, study sites in Finland, Norway, Belgium and Italy have opened for patient recruitment. In total, ALBINO is now recruiting in 10 countries.

Recruitment now open in Estonia and Spain

published: March 14th 2019

The ALBINO-consortium happily announces the official opening of the first centers for patient recruitment in Estonia and Spain.

Recruitment open and first patient included in Austria

published: November 28th 2018

Recruitment for the ALBINO-study was successfully opened in Austria, and the first patient has been enrolled already.

First Patients Included

published: July 10th 2018

Since the opening of the first study sites in the Netherlands and Germany, 4 patients have been successfully included into the ALBINO-trial (2 in the Netherlands, 2 in Germany).

Recruitment now open in Switzerland

published: July 10th 2018
The ALBINO-consortium happily announces the official opening of two centres for patient recruitment in Switzerland.

Recruitment now open in the Netherlands and Germany

published: June 6th 2018

The ALBINO-consortium happily announces the official opening of several centres for patient recruitment in the Netherlands and Germany. We are confident that more countries will follow soon.

Approvals received in Portugal

published: November 21st 2019

On 08 November, 2019 partner UPORTO received all necessary approvals to start patient recruitment for the ALBINO-trial in Portugal. Portugal is now the 11th country recruiting for ALBINO.

Events

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Past Events

Next ALBINO Consortium-meeting to be held on 19 March, 2024, March 19th 2024

The ALBINO-Consortium will reconvene in Berlin on March 19,2024 to discuss the progress of the clinical trial and the project as a whole and to define priorities for the final year of the project duration.

ALBINO-trial presented at C4C Multi-Stakeholder Meeting on Perinatal Asphyxia in Rome on 18 and 19 September 2023, September 19th 2023

The ALBINO-trial will be presented and be part of the expert discussion at the C4C Multi-Stakeholder Meeting on Perinatal Asphyxia in Rome on 18 and 19 September 2023. For more information, see: (https://conect4children.org/2023/07/19/msm_perinatal-asphyxia/)

Next ALBINO Consortium-meeting to be held at 5th Congress of joint European Neonatal Societies (JENS), September 21st 2023

The ALBINO-Consortium will reconvene on September 20 and 21 during the 5th JENS-Congress in Rome to assess progress and next steps to be taken in the project and the clini-cal trial.

ALBINO Consortium Meeting and Presentation of WP8-results at EAPS 2022 in Barcelona 07-10 October 2022, October 10th 2022

The ALBINO-Consortium will hold its first in-person meeting since November 2019 in Barcelona during the 9th Congress of the European Academy of Paediatric Socie-ties (EAPS) in Barcelona on 10 October, 2022. Results of ALBINO Work Package 8 (Pharmacokinetics) will also be presented at EAPS 2022.

ALBINO Investigator Meeting at GNPI 2020, June 18th 2020

The ALBINO-trial will be present at the 46th Annual Conference of the German Society for Neonatology and Paediatric Intensive Care (GNPI) in Berlin, Germany, Estrel-Hotel and Congress Center, from June 18-20, 2020.
Further information is available at gnpi2020.de.

ALBINO-investigators from Germany, Austria and Switzerland will convene room NIZZA on Friday, 18 June, 2020, 11.15-12.15 am. All participating investigators and interested new investigators are cordially invited to join and learn about the latest news and conditions for trial participation.

ALBINO Presentation at the 11th Dresden Symposium on Delivery Room Management and Regenerative Therapies, March 5th 2020

The ALBINO-trial will be presented by Axel Franz in the session on Neonatal Brain Injury on Thursday, 05 March, 2020.
Further information is available at here

Next ALBINO General Assembly Meeting in Berlin, March 4th 2020

The members of the ALBINO-consortium will once again meet on 04 March, 2020 at Berlin, Tegel Airport.

ALBINO Investigator Meeting in Germany, May 24th 2019

The next investigator meeting for participating and interested centers will take place at the annual GNPI congress 2019 in Leipzig. The meeting will be held on 24 May, 2019, 12-1pm.

ALBINO Consortium Meeting in Germany, April 10th 2019

The ALBINO consortium will convene in Frankfurt, Germany on 10 April, 2019 for its first consortium meeting in 2019.

ALBINO Investigator Meetings in Italy and Norway, June 11th 2018

In order to speed up the trial roll-out in further European countries, investigator meetings will be held in Italy and Norway. In Italy the meeting will take place at the Hotel Courtyard by Marriott in Tessera, Venice on 11 June, 2018, 11 am to 4 pm. In Norway, investigators will convene at Oslo University Hospital on 12 June, 2018, from 9 am until 4 pm.

ALBINO Investigator Meeting at GNPI 2018, June 9th 2018

The ALBINO-trial will be present at the 44th Annual Conference of the German Society for Neonatology and Paediatric Intensive Care (GNPI) in Rostock, Germany, from June 07-09, 2018. Further information is available at www.gnpi2018.de.

ALBINO-investigators from Germany, Austria and Switzerland will convene in Hall 8 on Saturday, 09 June, 2018, 12.45-1.45 pm. All participating investigators and interested new investigators are cordially invited to join and learn about the latest news and conditions for trial participation.

ALBINO presented at the “9th Dresden Symposium on Delivery Room Manage-ment, Asphyxia, Hypothermia and Stem cell research, March 9th 2018

The progress and state of affairs of the ALBINO-study will be presented at the “9th Dresden Symposium on Delivery Room Management, Asphyxia, Hypothermia and Stem cell re-search” which is held from 08-09 March, 2018 in Dresden, Germany. This symposium is a regular convention of national and international researchers and experts on hypothermia, and we hope for interesting inputs and discussions for various perspectives.

Annual ALBINO-Meeting to be held in Dresden, Germany, March 7th 2018

The ALBINO-consortium will hold its annual meeting in Dresden, Germany on 07 March, 2018. For the 2nd time, the annual spring meeting will be hosted by TUD and EKUT. We are looking forward to fruitful discussions among all partners.

Publication

New Publication on the statistical analysis plan of the ALBINO-trial available in Trials

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)

Corinna Engel, Mario Rüdiger, Manon J N L Benders, Frank van Bel, Karel Allegaert , Gunnar Naulaers, Dirk Bassler , Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck , Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Roselinda van der Vlught, Axel R Franz; ALBINO Study Group

is now available Trials. 2024 Jan 24;25(1):81. doi: 10.1186/s13063-023-07828-6a

New Publication from ALBINO-trial on parental consent published in Archives in Disease in Childhood (Arch Dis Child)

The latest publication from the ALBINO-project “Parental perspectives about infor-mation and deferred versus two-stage consent in studies of neonatal asphyxia“

Maiwald CA, Rovers C, Janvier A, et al.

is now available in Arch Dis Child Fetal Ne-onatal Ed. 2023 Aug 30 (Online ahead of print), doi: 10.1136/archdischild-2023-325900.

New Publication from ALBINO Work Package 8 (Pharmacokinetics) available in Clinical Pharmacokinetics

Open Access paper “Semi-mechanistic Modeling of Hypoxanthine, Xanthine, and Uric Acid Metabolism in Asphyxiated Neonates”

Wan-Yu Chu, Karel Allegaert, Thomas P. C. Dorlo, Alwin D. R. Huitema

Published online 30 August 2022

Clinical Pharmacokinetics https://doi.org/10.1007/s40262-022-01164-9
https://link.springer.com/article/10.1007/s40262-022-01164-9

Results of ALBINO PK-Analysis (ALBINO Work Package 8) published in Clinical Pharmacokinetics

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

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

Published online 07 October 2021

Clinical Pharmacokinetics https://doi.org/10.1007/s40262-021-01068-0
https://link.springer.com/article/10.1007/s40262-021-01068-0

Five peer reviewed papers on ALBINO Work Package 6 published

WP6 Lead Partner UMCU published five papers on MRI-analyses in the context of HIE-diagnosis in term born neonates in “Pediatric Research” and the “American Journal of Neuroradiology”:

Mammillary body atrophy and other MRI correlates of school-age outcome following neonatal hypoxic-ischemic encephalopathy. Kim V Annink, Linda S de Vries , Floris Groenendaal, Rian M J C Eijsermans, Manouk Mock-ing, Monique M J van Schooneveld, Jeroen Dudink, Henrica L M van Straaten, Manon J N L Benders, Maarten Lequin, Niek E van der Aa. Sci Rep. 2021 Mar 3;11(1):5017. doi: 10.1038/s41598-021-83982-8.

Introduction of Ultra-High-Field MR Imaging in Infants: Preparations and Feasibility. Annink KV, van der Aa NE, Dudink J, Alderliesten T, Groenendaal F, Lequin M, Jansen FE, Rhebergen KS, Luijten P, Hendrikse J, Hoogduin HJM, Huijing ER, Versteeg E, Visser F, Raaijmakers AJE, Wiegers EC, Klomp DWJ, Wijnen JP, Benders MJNL. AJNR Am J Neuroradiol. 2020 Aug;41(8):1532-1537. doi: 10.3174/ajnr.A6702. Epub 2020 Jul 30.

The development and validation of a cerebral ultrasound scoring system for infants with hy-poxic-ischaemic encephalopathy. Annink KV, de Vries LS, Groenendaal F, Vijlbrief DC, Weeke LC, Roehr CC, Lequin M, Reiss I, Govaert P, Benders MJNL, Dudink J. Pediatr Res. 2020 Mar;87(Suppl 1):59-66. doi: 10.1038/s41390-020-0782-0.

Cerebellar injury in term neonates with hypoxic-ischemic encephalopathy is underestimated. Annink KV, Meerts L, van der Aa NE, Alderliesten T, Nikkels PGJ, Nijboer CHA, Groenen-daal F, de Vries LS, Benders MJNL, Hoebeek FE, Dudink J. Pediatr Res. 2020 Sep 23. doi: 10.1038/s41390-020-01173-z. Online ahead of print.

Brain temperature of infants with neonatal encephalopathy following perinatal asphyxia cal-culated using magnetic resonance spectroscopy. Annink KV, Groenendaal F, Cohen D, van der Aa NE, Alderliesten T, Dudink J, Benders MJNL, Wijnen JP. Pediatr Res. 2020 Aug; 88(2):279-284. doi: 10.1038/s41390-019-0739-3. Epub 2020 Jan 2.

First results from WP8 published in Clinical Pharmacokinetics

WP8 Academic Lead Partner KULEUVEN and the study group involved in WP 8 pub-lished important results on pharmacokinetics in the ALBINO trial:

Glomerular Filtration Rate in Asphyxiated Neonates Under Therapeutic Whole-Body Hypo-thermia, Quantified by Mannitol Clearance. 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, Allegaert K; ALBI-NO Study Group. Clin Pharmacokinet. 2021 Feb 21. doi: 10.1007/s40262-021-00991-6. On-line ahead of print.

Second peer-reviewed publication on ALBINO now available in BMC Pediatrics

Maiwald et al.’s paper “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)” is now available in BMC Pediatrics. Please visit https://rdcu.be/bH0i2 for open access to full text.

First peer-reviewed journal article on ALBINO has been published

Annink et al.’s review article “Allopurinol: Old Drug, New Indication in Neonates?“ is now available in Current Pharmaceutical Design, https://benthamscience.com/journals/current-pharmaceutical-design.