Effect of Allopurinol in addition to hypothermia for hypoxic-ischemicBrain Injury on Neurocognitive Outcome

Phase 1

• Conditions: hypoxic-ischemic brain injury; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000222-19-ES
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 846

Inclusion Criteria

Term and near-term infants with a history of disturbed labour who meet at least one criterion of perinatal acidosis (or ongoing resuscitation) and at least two early clinical signs of potentially evolving encephalopathy as defined herein:

Severe perinatal metabolic acidosis or ongoing cardiopulmonary resuscitation at 5 min after birth:

At least 1 out of the following 5 criteria must be met
- Umbilical (or arterial or reliable venous) blood gas within 30 min after birth with pH<7.0
- Umbilical (or arterial or reliable venous) blood gas within 30 min after birth with base deficit =16 mmol/l
- Need for ongoing cardiac massage at/beyond 5 min postnatally
- Need for adrenalin administration during resuscitation
- APGAR score =5 at 10min

AND
Early clinical signs of potentially evolving encephalopathy:

At least 2 out of the following 4 criteria must be met:

- Altered state of consciousness (reduced or absent response to stimulation or hyperexcitability)
- Severe muscular hypotonia or hypertonia,
- Absent or insufficient spontaneous respiration (e.g., gasping only) with need for respiratory support at 10 min postnatally,
- Abnormal primitive reflexes (absent suck or gag or corneal or Moro reflex) or abnormal movements (e.g., potential clinical correlates of seizure activity)
Are the trial subjects under 18? yes
Number of subjects for this age range: 846
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- gestational age below 36 weeks
- birth weight below 2500 g
- postnatal age >30min at the end of screening phase
- severe congenital malformation or syndrome requiring neonatal surgery or affecting longterm outcome
- patient considered moribund”
- decision for comfort care only” before study drug administration
- parents declined study participation as response to measures of community engagement
- parents haven’t had the chance to appraise the conduct of the ALBINO study at the study site and to refute that their child may receive study drug in the event of asphyxia/HIE
- both parents are insufficiently fluent in the study site’s national language(s) or English or do not have the intellectual capacity to understand the study procedures and to give consent as judged by the personel who had been in contact with the mother/father before
delivery.
- both parents/guardians less than 18 years of age, in case of single parent/guardian this one less than 18 years of age

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified