Effect of ALlopurinol in addition to hypothermia for hypoxicischemic Brain Injury on Neurocognitive Outcome
- Conditions
- Brain injury termed “hypoxic-ischemic encephalopathy” (HIE) as a result of various events during labour and childbirth such as placental abruption, uterine rupture, umbilical cord complications, etc.)
- Registration Number
- 2024-511322-31-00
- Lead Sponsor
- Universitaetsklinikum Tuebingen AöR
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 452
Severe perinatal metabolic acidosis or ongoing cardiopulmonary resuscitation at 5 min after birth
Early clinical signs of potentially evolving encephalopathy
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Motor-Composite-Score (Bayley III) 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). 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. 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. 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 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 (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 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 (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 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. 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.
Trial Locations
- Locations (44)
Tartu University Hospital
🇪🇪Tartu, Estonia
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Helsingin ja Uudenmaan Sairaanhoitopiirin Kuntayhtämy (HUS)
🇫🇮Helsingin, Finland
Jorvi Hospital, HUS
🇫🇮Helsinki, Finland
Hospital General Alicante
🇪🇸Alicante, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Complejo Hospitalario Universitario
🇪🇸Santiago de Compostela, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen De Las Nieves
🇪🇸Granada, Spain
Hospital Universitario Puerta Del Mar
🇪🇸Cadiz, Spain
Scroll for more (34 remaining)Tartu University Hospital🇪🇪Tartu, EstoniaTuuli MetsvahtSite contact003727319550tuuli.metsvaht@kliinikum.ee