A European trial to evaluate the effect of Allopurinol administered very early after birth on brain injury in children with oxygen deficiency during birth

Phase 1

• Conditions: Perinatal Asphyxia, hypoxic-ischemic brain injury; MedDRA version: 20.0Level: PTClassification code 10028923Term: Neonatal asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10014633Term: Encephalopathy neonatalSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Last Update Posted: 26 February 2018

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 sign of perinatal asphyxia and early clinical signs of potentially evolving encephalopathy as defined herein:
Perinatal asphyxia:
At least 1 out of the following 4criteria 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 or 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 the screening phase
-severe congenital malformation or syndrome requiring neonatal
surgery or affecting long-term outcome
-patient considered moribund” or decision for comfort care only”
before study drug administration
-parents declined study participation as response to community
engagment
-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 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 underaged, in case of single parent/guardian this one underaged

Study & Design

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