Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome – a blinded randomized placebo-controlled parallel group multicenter trial for superiority (Phase III) - ALBINO

niversity Hospital Tuebingen0 个研究点目标入组 846 人开始时间: 2017年9月25日最近更新: 2018年1月22日

适应症

试验速览

暂无简介。

•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
•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

•-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
•-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

发起方

niversity Hospital Tuebingen