760
Participants
Start Date
March 25, 2018
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Allopurinol
Allopurinol, powder for injection (PFI), administered in two doses. First dose (20 mg/kg in 2ml/kg sterile water for injection) given as soon as intravenous access is established and no later than 30min postnatally and second dose (10mg/kg in 1ml/kg sterile water for injection) 12 hours thereafter. The second dose will only be administered to in infants on therapeutic hypothermia. Infants who recover quickly and do not qualify for and hence do not undergo hypothermia will not receive a second dose. Administration will be by continuous infusion using a syringe pump over 10min through secure venous access.
Mannitol
Placebo (Mannitol, PFI, 20mg/kg in the same volume and at the same time intervals as the intervention group - (2nd dose 10mg/kg only if infant undergoes therapeutic hypothermia)).
RECRUITING
Medizinische Universitaet Wien, Vienna
RECRUITING
Katholieke Universiteit Leuven, Leuven
RECRUITING
Universitaet Zuerich, Zurich
RECRUITING
Universita Degli Studi Di Udine, Udine
RECRUITING
Para La Investigacion Del Hospital UniversitarioLa Fe De La Comunidad Valenciana, Valencia
RECRUITING
Tartu Ulikool, Tartu
WITHDRAWN
Uniwersytet Medyczny Im Karola Marcinkowskiego W Poznaniu, Poznan
RECRUITING
University Hospital Tübingen, Tübingen
RECRUITING
Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä, Helsinki
RECRUITING
Universitair Medisch Centrum Utrecht, Utrecht
RECRUITING
Oslo Universitetssykehus Hf, Oslo
WITHDRAWN
Universidade Do Porto, Porto
Collaborators (1)
Technische Universität Dresden
OTHER
UMC Utrecht
OTHER
KU Leuven
OTHER
University of Zurich
OTHER
University of Vienna
OTHER
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Universidade do Porto
OTHER
Oslo University Hospital
OTHER
Università degli Studi di Udine
UNKNOWN
Helsingin Ja Uudenmaan Sairaanhoitopiirin
UNKNOWN
University of Helsinki
OTHER
Poznan University of Medical Sciences
OTHER
Tartu University Hospital
OTHER
ACE Pharmaceuticals BV
OTHER
University Hospital Tuebingen
OTHER