Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

PHASE3RecruitingINTERVENTIONAL
Enrollment

760

Participants

Timeline

Start Date

March 25, 2018

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Encephalopathy, Hypoxic-IschemicInfant, Newborn, Diseases
Interventions
DRUG

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.

DRUG

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)).

Trial Locations (12)

1090

RECRUITING

Medizinische Universitaet Wien, Vienna

3000

RECRUITING

Katholieke Universiteit Leuven, Leuven

8006

RECRUITING

Universitaet Zuerich, Zurich

33100

RECRUITING

Universita Degli Studi Di Udine, Udine

46026

RECRUITING

Para La Investigacion Del Hospital UniversitarioLa Fe De La Comunidad Valenciana, Valencia

50090

RECRUITING

Tartu Ulikool, Tartu

61701

WITHDRAWN

Uniwersytet Medyczny Im Karola Marcinkowskiego W Poznaniu, Poznan

72076

RECRUITING

University Hospital Tübingen, Tübingen

00029

RECRUITING

Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä, Helsinki

3584 CX

RECRUITING

Universitair Medisch Centrum Utrecht, Utrecht

0450

RECRUITING

Oslo Universitetssykehus Hf, Oslo

4099 002

WITHDRAWN

Universidade Do Porto, Porto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Technische Universität Dresden

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

KU Leuven

OTHER

collaborator

University of Zurich

OTHER

collaborator

University of Vienna

OTHER

collaborator

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

collaborator

Universidade do Porto

OTHER

collaborator

Oslo University Hospital

OTHER

collaborator

Università degli Studi di Udine

UNKNOWN

collaborator

Helsingin Ja Uudenmaan Sairaanhoitopiirin

UNKNOWN

collaborator

University of Helsinki

OTHER

collaborator

Poznan University of Medical Sciences

OTHER

collaborator

Tartu University Hospital

OTHER

collaborator

ACE Pharmaceuticals BV

OTHER

lead

University Hospital Tuebingen

OTHER

NCT03162653 - Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome | Biotech Hunter | Biotech Hunter