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)

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ALBINO Study Group , Maiwald , C A , Annink , K V , Rüdiger , M , Benders , M J N L , Van Bel , F , Allegaert , K , Naulaers , G , Bassler , D , Klebermaß-Schrehof , K , Vento , M , Guimarães , H , Stiris , T , Cattarossi , L , Metsäranta , M , Vanhatalo , S , Mazela , J , Metsvaht , T & Jacobs , Y 2019 , ' 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) ' , BMC Pediatrics , vol. 19 , no. 1 , 210 . https://doi.org/10.1186/s12887-019-1566-8

Title: 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: ALBINO Study Group; Maiwald, C.A.; Annink, K.V.; Rüdiger, M.; Benders, M.J.N.L.; Van Bel, F.; Allegaert, K.; Naulaers, G.; Bassler, D.; Klebermaß-Schrehof, K.; Vento, M.; Guimarães, H.; Stiris, T.; Cattarossi, L.; Metsäranta, M.; Vanhatalo, S.; Mazela, J.; Metsvaht, T.; Jacobs, Y.
Contributor: University of Helsinki, HUS Children and Adolescents
University of Helsinki, Department of Neurosciences
Date: 2019
Language: eng
Number of pages: 10
Belongs to series: BMC Pediatrics
ISSN: 1471-2431
URI: http://hdl.handle.net/10138/327644
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. © 2019 The Author(s).
Subject: Allopurinol
Brain injury
Cerebral palsy
Childbirth outcome
Hypothermia therapy
Hypoxic-ischemic encephalopathy
Neonatal oxygen deficiency
Perinatal asphyxia
allopurinol
protein S100B
antimetabolite
Article
birth weight
controlled study
disease severity
double blind procedure
drug effect
drug efficacy
drug safety
drug screening
echoencephalography
electroencephalogram
gestational age
groups by age
health care quality
heart function
human
hypothermia
hypoxic ischemic encephalopathy
incidence
major clinical study
mental disease
newborn
newborn mortality
nuclear magnetic resonance imaging
perinatal asphyxia
phase 3 clinical trial
randomized controlled trial
treatment outcome
induced hypothermia
infant
mortality
multicenter study (topic)
multimodality cancer therapy
phase 3 clinical trial (topic)
procedures
randomized controlled trial (topic)
Antimetabolites
Clinical Trials, Phase III as Topic
Combined Modality Therapy
Double-Blind Method
Gestational Age
Humans
Hypothermia, Induced
Hypoxia-Ischemia, Brain
Infant
Infant, Newborn
Multicenter Studies as Topic
Neurodevelopmental Disorders
Randomized Controlled Trials as Topic
3123 Gynaecology and paediatrics
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