Am J Perinatol 2018; 35(S 01): S1-S26
DOI: 10.1055/s-0038-1647082
Abstracts
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The Albino Trail Effect of Allopurinol in Addition to Hypothermia for Hypoxic-Ischemic Brain Injury on Neurocognitive Outcome

I. Mauro
1   NICU, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy
,
A. Franz
2   Center for Pediatric Clinical Studies, Universitätsklinikum Tübingen, Tübingen, Germany
,
E. Baraldi
3   Women’s and Children’s Health Department, University of Padova, Padova, Italy
,
V. Carnielli
4   NICU, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona, Italy
,
G. Paterlini
5   NICU, ASST DI MONZA - Ospedale San Gerardo, Monza, Italy
,
M. Napolitano
6   Ospedale Evangelico Villa Betania, Napoli, Italy
,
P. F. Faldini
7   NICU, Ospedale Valduce, Como, Italy
,
M. Barbarini
8   NICU, ASST-Lariana, Ospedale Sant'Anna, Como, Italy
,
G. Lista
9   NICU, ASST FBF-Sacco Ospedale dei Bambini “V.Buzzi,” Milan, Italy
,
G. Visintin
10   NICU, ULLS9- Ospedale Ca' Foncello di Treviso, Treviso, Italy
,
E. Mastretta
11   NICU, Presidio Ospedaliero S.Anna, Città della Salute e della Scienza di Torino, Turin, Italy
,
G. Vento
12   Fondazione Policlinico Universitario Gemelli-Università Cattolica del Sacro Cuore, Rome, Italy
,
M. Fumagalli
13   NICU, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milano, Milan, Italy
,
M. Binotti
14   NICU, Ospedale Maggiore della Carità, Novara, Italy
,
L. Cattarossi
1   NICU, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy
› Author Affiliations
Further Information

Publication History

Publication Date:
27 April 2018 (online)

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Introduction: Neonatal brain damage due to hypoxic-ischemic event is a major burden in the western world. Hypothermia is the first-line treatment, but the risk of death and long-term neurodevelopmental impairment remains still high. Allopurinol, a xantine-oxidase inhibitor, reduces the production of oxygen radicals and may have a synergic action with hypothermia as shown in animal models. This European funded study aims to evaluate the efficacy and safety of Allopurinol in infants with hypoxic-ischemic encephalopathy.

Materials and Methods: The study is a blinded randomized placebo-controlled parallel group multicenter trial (around 60 centers of 12 countries in Europe are involved). Allopurinol or placebo (Mannitol) will be administered intravenously immediately after birth and 24 hours later and standard care (including hypothermia) will be started. The sample size necessary for the statistical power consists of 846 neonates. The study will evaluate the efficacy of Allopurinol in terms of reduction of death or severe neurodevelopmental impairment at 24 months of age.

Conclusion: Our project is the first study testing the activity of Allopurinol in human neonates. Recruitment of patients will took place in the first months of this year and the full trial will past 5 years. The major concern is the large patient’s sample which can be reached only involving a wide number of neonatal nurseries. At present time, 13 Italian neonatal units has been recruited.

Keywords: hypoxic-ischemic encephalopathy, allopurinol, hypothermia, neurodevelopmental outcome