News Events Publications
News
358 ALBINO patients have completed follow-up
published: December 13th 2024
Follow-up examinations at the age of 2 years have been completed for 358 patients enrolled in ALBINO as of 10 December, 2024.No actual news
News-Archive
Recruitment to the ALBINO trials was stopped after enrolment of 504 patients.
published: March 31st 2024
504 Patients have been included into the ALBINO study and will be followed to 24 months of age. With this sample size, ALBINO is one of the largest clinical trials ever conducted in the field of perinatal hypoxia/asphyxia and the results after completion of follow-up (to be expected earliest Q3/Q4 2026) will make an important contribution to future research and potentially also to patient care and wellbeing.Statistical Analysis Plan published
published: January 24th 2024
Detailed statistical analysis plan was submitted to Trials on 31 October 2023, accepted on 22 November 2023, and published online 24 January 2024. Engelo et al. Trials 2024;25:81 doi.org/10.1186/s13063-023-07828-6Database Closure for Interim Analysis
published: January 8th 2024
475 patients have been recruited into ALBINO
published: December 13th 2023
ALBINO patient "No. 300" has reached 2 years of age
published: October 18th 2023
Presentation of the Activities of the ALBINO project during the "Connect-for-Children (IMI-c4c)" Multistakeholder-Meeting on Asphyxia on Sept. 18+19. 2023 in Rome, Italy
published: September 19th 2023
Along activities of other consortia concerning development of Erythropoietin, Melantonin, Stem cells, and other potential medications to improve outcome following perinatal asphyxia, the ALBINO project was presented and discussed. Major challenge in ALBINO is the early postnatal administration. A panel discussion addressed the issue on how to best obtain parental consent and how parent representatives could be involved - to which the PreALBINO results were contributed.Pre-ALBINO study results on parental perspectives about consent was published
published: August 10th 2023
Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia has been published open-access (https://dx.doi.org/10.1136/archdischild-2023-325900). The key messages are: Considering parental perspectives is essential and two-stage consent with the opportunity to opt-out may be a good approach. The manuscript has been submitted June 2023 and was accepted 10 August 2023393 patients have been recruited into ALBINO
published: December 31st 2022
Additional Pharmacokinetic analyses give important insight into purin-biomarker metabolism in perinatal asphyxia
published: August 30th 2022
The extended pharmacokinetic-pharmacodynamic model developed herein, 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 manuscript was accepted: 24 July 2022 and published online: 30 August 2022320 patients have been recruited into ALBINO
published: December 31st 2021
Pharmakokinetic substudy confirms that allopurinol dosing in ALBINO achieves targeted inhibition of the enzym xanthine oxidase
published: October 7th 2021
The dosing regimen applied in the ALBINO trial leads to the targeted XO inhibition in neonates treated with or without therpeutic hypothermia. (rdcu.be/dXX0H). The manuscript was accepted on: 10 August 2021 and published online on: 7 October 2021211 patients have been recruited into ALBINO
published: December 31st 2020
ALBINO study protocol published open access
published: June 27th 2019
To achive full transparency, the major contents of the ALBINO study protocol have been published open-access (Maiwald et al. BMC Pediatrics 2019;19:210 doi.org/10.1186/s12887-019-1566-8) in addition to previous trial registration on www.clinicaltrials.gov. The manuscript was submitted on 21 February 2019 and accepted on 31 May 2019.
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
No upcoming Events
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.