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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)

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)

Data de publicació: 27/06/2019

Autors de IIS La Fe

Máximo Vento Torres

Autor

Autors aliens a IIS La Fe

Benders, MJNL
Klebermass-Schrehof, K
Metsaranta, M
Rudiger, M
Poets, CF
Benders, M
Allegaert, K
Naulaers, G
Klebermass-Schrehof, K
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
Metsaranta, M
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
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
ALBINO Study Grp

Grups d'Investigació

Perinatología

Leader

Máximo Vento Torres

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.

Dades de la publicació

ISSN/ISSNe:: 1471-2431, 1471-2431
Tipus:: Article
Pàgines:: 210-210
DOI:: 10.1186/s12887-019-1566-8
PubMed:: 31248390
Factor d'Impacte:: 0,853 SCImago ℠
Quartil:: Q1 SCImago ℠

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Keywords

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