2024-511322-31-00招募中3 期
Effect of ALlopurinol in addition to hypothermia for hypoxicischemic Brain Injury on Neurocognitive Outcome
Universitaetsklinikum Tuebingen AöR44 个研究点 分布在 9 个国家目标入组 452 人开始时间: 2024年9月10日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 452
- 试验地点
- 44
- 主要终点
- Death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years
研究概览
简要总结
To evaluate whether in newborns with asphyxia and early clinical signs of hypoxic ischemic encephalopathy, early postnatal allopurinol compared to placebo administered in addition to standard of care (including therapeutic hypothermia if indicated) reduces the incidence of death or severe neurodevelopmental impairment (defined as cerebral palsy, or cognitive or language impairment, the latter defined as cognitive- and the language-composite scores of the Bayley Scales of Infant and Toddler Development (3rd edition) <85) at 24 months of age.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Severe perinatal metabolic acidosis or ongoing cardiopulmonary resuscitation at 5 min after birth
- •Early clinical signs of potentially evolving encephalopathy
排除标准
- •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 long-term outcome
- •patient considered “moribund” / “non-viable” (e.g., lack of spontaneous cardiac activity and ongoing chest compression at 30min)
结局指标
主要结局
Death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years
Death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years
次要结局
- Motor-Composite-Score (Bayley III)
- Death or neurodevelopmental impairment (NDI) The primary endpoint will be reconstituted as dichotomised composite secondary endpoint (survival without NDI versus Death or languagecomposite- score < 85 or cognitive-composite-score <85 or cerebral palsy present).
- Incidence of CP Incidence of CP will be analyzed by Cochrane-Mantel-Haenzel- X²-Test.
- GMFCS-score GMFCS-Score for quantification of the effects of cerebral palsy and other motor impairments (adapted from Palisano et al. [Palisano Med Child Neurol 1997]) using the ALBINO-GMFCS-score sheet (separate document not part of this protocol) will be analysed. GMFCS-score consists of six categories.
- Motor-Composite-Score dichotomised (Bayley III) The motor-composite-score will be dichotomised at the cut-off <85 versus ≥85
- Cognitive-Composite-Score (cognitive subscale, Bayley III)
- Cognitive-Composite-Score dichotomised (cognitive subscale, Bayley III) The cognitive-composite-score will be dichotomised at the cut-off <85 versus ≥85
- Language-Composite-Score (language subscale, Bayley III)
- Language-Composite-Score dichotomised (language subscale, Bayley III) The language-composite-score will be dichotomised at the cut-off <85 versus ≥85
- Single Components of primary endpoint - Graph Single components and observed combinations of the primary endpoint (healthy, death, CP, language-composite-score <85, cognitivecomposite- score <85) will be displayed graphically stratified for the two treatment groups.
研究者
Axel Franz
Scientific
Universitaetsklinikum Tuebingen AöR
研究点 (44)
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